Alicia Ault

FDA Warns Lilly on Adcirca Promos

The Food and Drug Administration has issued a warning to Eli Lilly & Co. and United Therapeutics that a Web page and two patient videos were in violation of the agency's promotional rules. Adcirca (tadalafil) is indicated for pulmonary arterial hypertension to improve exercise ability. The FDA cited the Web page for failing to include any contraindications, warnings, or precautions for the drug, which “misleadingly suggests that Adcirca is safer than has been demonstrated,” said the warning letter. The two patient videos “seriously misrepresent what is known about the efficacy of Adcirca,” said the FDA. The agency directed the drug makers to immediately cease dissemination of the offending materials.

ICD Study Collaboration

The Agency for Healthcare Research and Quality (AHRQ) and the American College of Cardiology are joining on a $3.5-million project to study the long-term benefits and risks of implantable cardioverter defibrillators in patients at risk of death from ventricular fibrillation. The three-and-a-half-year study will be carried out by a network of 15 health care delivery systems and is being led by Dr. Frederick Masoudi of Kaiser Permanente Colorado and Dr. Robert Greenlee of the Marshfield (Wisc.) Clinic Research Foundation. The network is supported by the AHRQ. Over the first 2 years, 3,500 patients will be followed to determine how often shocks are delivered and if they are appropriate, and to determine who is most likely to require defibrillation. In the final year, the data will be analyzed.

No FDA Conflict on Heparin

The FDA revealed in early February that a federal investigation had cleared Dr. Janet Woodcock of any conflict-of-interest allegations over her involvement with Momenta Pharmaceuticals, a company that was seeking approval for a generic version of Lovenox, a low-molecular-weight heparin. In an ethics complaint filed in mid-2009, Amphastar Pharmaceuticals claimed that Dr. Woodcock, director of the FDA's Center for Drug Evaluation and Research, was biased in favor of Momenta because she had worked with the company in investigating the tainting of Chinese heparin. Now, the Inspector General of the Department of Health and Human Services has ruled that there was no conflict. The controversy aside, Wall Street analysts at Rodman & Renshaw say they predict that Momenta's generic will win approval in this quarter.

PQRI Reminder

In 2010, the Physician Quality Reporting Initiative (PQRI) will include several new measures on coronary artery disease and heart failure. To qualify for the 2% bonus, physicians have to report on only 30 patients. In the past, they had to report on 80% of eligible patients, according to the American College of Cardiology. In addition, there are five individual measures that can be reported through a registry. Cardiologists can use the ACC's Pinnacle Registry (formerly the IC3 Program) for PQRI reporting.

New York Limits Its Salt

The New York City Health Department said it will ask restaurants and producers of packaged food to voluntarily reduce sodium in their meals and products by 25% over 5 years in an effort to curb high blood pressure and heart disease. The department acted as leader of the National Salt Reduction Initiative, a partnership of cities, states, and health organizations. The New York agency said that nearly 80% of the sodium in Americans' diets is added to foods before they are sold. After a year of consultation with food industry leaders, the coalition has developed targets for salt reductions in various foods. In a statement following the New York announcement, Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention, endorsed such efforts: “The majority of Americans are consuming about twice the recommended limit of sodium each day, and not by choice. Achieving substantial reductions in sodium levels by incremental decreases in sodium content across the food supply can save many lives while maintaining good taste.”

No Smoke, No Device Authority

The U.S. District Court for the District of Columbia ruled that the Food and Drug Administration does not have the authority to regulate so-called e-cigarettes (electronic cigarettes) as a drug-device combination. E-cigarettes are battery-powered devices that deliver vaporized doses of nicotine to be inhaled. The FDA had detained multiple shipments of e-cigarettes imported by one company, Smoking Everywhere, saying that they were unapproved drug-devices. Judge Richard J. Leon disagreed with the FDA's justification for its action. However, he did not address whether the agency has authority to regulate e-cigarettes under the Family Smoking Prevention and Tobacco Control Act, which President Obama signed into law last June, after the e-cigarette shipments in this case had been halted.

FDA Warns Lilly on Adcirca Promos

The Food and Drug Administration has issued a warning to Eli Lilly & Co. and United Therapeutics that a Web page and two patient videos were in violation of the agency's promotional rules. Adcirca (tadalafil) is indicated for pulmonary arterial hypertension to improve exercise ability. The FDA cited the Web page for failing to include any contraindications, warnings, or precautions for the drug, which “misleadingly suggests that Adcirca is safer than has been demonstrated,” said the warning letter. The two patient videos “seriously misrepresent what is known about the efficacy of Adcirca,” said the FDA. The agency directed the drug makers to immediately cease dissemination of the offending materials.

ICD Study Collaboration

The Agency for Healthcare Research and Quality (AHRQ) and the American College of Cardiology are joining on a $3.5-million project to study the long-term benefits and risks of implantable cardioverter defibrillators in patients at risk of death from ventricular fibrillation. The three-and-a-half-year study will be carried out by a network of 15 health care delivery systems and is being led by Dr. Frederick Masoudi of Kaiser Permanente Colorado and Dr. Robert Greenlee of the Marshfield (Wisc.) Clinic Research Foundation. The network is supported by the AHRQ. Over the first 2 years, 3,500 patients will be followed to determine how often shocks are delivered and if they are appropriate, and to determine who is most likely to require defibrillation. In the final year, the data will be analyzed.

No FDA Conflict on Heparin

The FDA revealed in early February that a federal investigation had cleared Dr. Janet Woodcock of any conflict-of-interest allegations over her involvement with Momenta Pharmaceuticals, a company that was seeking approval for a generic version of Lovenox, a low-molecular-weight heparin. In an ethics complaint filed in mid-2009, Amphastar Pharmaceuticals claimed that Dr. Woodcock, director of the FDA's Center for Drug Evaluation and Research, was biased in favor of Momenta because she had worked with the company in investigating the tainting of Chinese heparin. Now, the Inspector General of the Department of Health and Human Services has ruled that there was no conflict. The controversy aside, Wall Street analysts at Rodman & Renshaw say they predict that Momenta's generic will win approval in this quarter.

PQRI Reminder

In 2010, the Physician Quality Reporting Initiative (PQRI) will include several new measures on coronary artery disease and heart failure. To qualify for the 2% bonus, physicians have to report on only 30 patients. In the past, they had to report on 80% of eligible patients, according to the American College of Cardiology. In addition, there are five individual measures that can be reported through a registry. Cardiologists can use the ACC's Pinnacle Registry (formerly the IC3 Program) for PQRI reporting.

New York Limits Its Salt

The New York City Health Department said it will ask restaurants and producers of packaged food to voluntarily reduce sodium in their meals and products by 25% over 5 years in an effort to curb high blood pressure and heart disease. The department acted as leader of the National Salt Reduction Initiative, a partnership of cities, states, and health organizations. The New York agency said that nearly 80% of the sodium in Americans' diets is added to foods before they are sold. After a year of consultation with food industry leaders, the coalition has developed targets for salt reductions in various foods. In a statement following the New York announcement, Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention, endorsed such efforts: “The majority of Americans are consuming about twice the recommended limit of sodium each day, and not by choice. Achieving substantial reductions in sodium levels by incremental decreases in sodium content across the food supply can save many lives while maintaining good taste.”

No Smoke, No Device Authority

The U.S. District Court for the District of Columbia ruled that the Food and Drug Administration does not have the authority to regulate so-called e-cigarettes (electronic cigarettes) as a drug-device combination. E-cigarettes are battery-powered devices that deliver vaporized doses of nicotine to be inhaled. The FDA had detained multiple shipments of e-cigarettes imported by one company, Smoking Everywhere, saying that they were unapproved drug-devices. Judge Richard J. Leon disagreed with the FDA's justification for its action. However, he did not address whether the agency has authority to regulate e-cigarettes under the Family Smoking Prevention and Tobacco Control Act, which President Obama signed into law last June, after the e-cigarette shipments in this case had been halted.

FDA Warns Lilly on Adcirca Promos

The Food and Drug Administration has issued a warning to Eli Lilly & Co. and United Therapeutics that a Web page and two patient videos were in violation of the agency's promotional rules. Adcirca (tadalafil) is indicated for pulmonary arterial hypertension to improve exercise ability. The FDA cited the Web page for failing to include any contraindications, warnings, or precautions for the drug, which “misleadingly suggests that Adcirca is safer than has been demonstrated,” said the warning letter. The two patient videos “seriously misrepresent what is known about the efficacy of Adcirca,” said the FDA. The agency directed the drug makers to immediately cease dissemination of the offending materials.

ICD Study Collaboration

The Agency for Healthcare Research and Quality (AHRQ) and the American College of Cardiology are joining on a $3.5-million project to study the long-term benefits and risks of implantable cardioverter defibrillators in patients at risk of death from ventricular fibrillation. The three-and-a-half-year study will be carried out by a network of 15 health care delivery systems and is being led by Dr. Frederick Masoudi of Kaiser Permanente Colorado and Dr. Robert Greenlee of the Marshfield (Wisc.) Clinic Research Foundation. The network is supported by the AHRQ. Over the first 2 years, 3,500 patients will be followed to determine how often shocks are delivered and if they are appropriate, and to determine who is most likely to require defibrillation. In the final year, the data will be analyzed.

No FDA Conflict on Heparin

The FDA revealed in early February that a federal investigation had cleared Dr. Janet Woodcock of any conflict-of-interest allegations over her involvement with Momenta Pharmaceuticals, a company that was seeking approval for a generic version of Lovenox, a low-molecular-weight heparin. In an ethics complaint filed in mid-2009, Amphastar Pharmaceuticals claimed that Dr. Woodcock, director of the FDA's Center for Drug Evaluation and Research, was biased in favor of Momenta because she had worked with the company in investigating the tainting of Chinese heparin. Now, the Inspector General of the Department of Health and Human Services has ruled that there was no conflict. The controversy aside, Wall Street analysts at Rodman & Renshaw say they predict that Momenta's generic will win approval in this quarter.

PQRI Reminder

In 2010, the Physician Quality Reporting Initiative (PQRI) will include several new measures on coronary artery disease and heart failure. To qualify for the 2% bonus, physicians have to report on only 30 patients. In the past, they had to report on 80% of eligible patients, according to the American College of Cardiology. In addition, there are five individual measures that can be reported through a registry. Cardiologists can use the ACC's Pinnacle Registry (formerly the IC3 Program) for PQRI reporting.

New York Limits Its Salt

The New York City Health Department said it will ask restaurants and producers of packaged food to voluntarily reduce sodium in their meals and products by 25% over 5 years in an effort to curb high blood pressure and heart disease. The department acted as leader of the National Salt Reduction Initiative, a partnership of cities, states, and health organizations. The New York agency said that nearly 80% of the sodium in Americans' diets is added to foods before they are sold. After a year of consultation with food industry leaders, the coalition has developed targets for salt reductions in various foods. In a statement following the New York announcement, Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention, endorsed such efforts: “The majority of Americans are consuming about twice the recommended limit of sodium each day, and not by choice. Achieving substantial reductions in sodium levels by incremental decreases in sodium content across the food supply can save many lives while maintaining good taste.”

No Smoke, No Device Authority

The U.S. District Court for the District of Columbia ruled that the Food and Drug Administration does not have the authority to regulate so-called e-cigarettes (electronic cigarettes) as a drug-device combination. E-cigarettes are battery-powered devices that deliver vaporized doses of nicotine to be inhaled. The FDA had detained multiple shipments of e-cigarettes imported by one company, Smoking Everywhere, saying that they were unapproved drug-devices. Judge Richard J. Leon disagreed with the FDA's justification for its action. However, he did not address whether the agency has authority to regulate e-cigarettes under the Family Smoking Prevention and Tobacco Control Act, which President Obama signed into law last June, after the e-cigarette shipments in this case had been halted.

Walgreens, the nation's largest drug store chain, is dipping a toe into diabetes care by offering education and counseling in four metropolitan areas.

The company's Optimal Wellness program is based on the North Carolina Center for Pharmaceutical Care's diabetes project and also draws on a Walgreens pilot that was developed by the drug store chain and Harvard's Joslin Diabetes Center.

The program initially will be offered in Indianapolis, Phoenix, Albuquerque, and Oklahoma City. These areas were chosen partly because of the large number of diabetic residents, said Dr. Jay Rosan, senior vice president of health innovation at Take Care Health Systems, a Walgreens company.

Dr. Mack Harrell, chair of the socioeconomics and member advocacy committee for the American Association of Clinical Endocrinologists, said the Walgreens program could be helpful but that AACE believes that any assistance, education, or counseling should be supervised by physicians.

“I'm in favor of people getting all the education they need,” Dr. Harrell said in an interview. But, he added, “what we've learned from a number of recent studies is that the degree of glycemic control has to be individualized. You have to know the patient, know whether they have comorbidities that put them at higher risk, and decide what degree of control is acceptable.”

These nuances are beyond the capacity of a nurse practitioner and reinforce the need for a supervisory physician, he said.

Dr. Rosan emphasized that the nurse practitioners in the Optimal Wellness program will not offer treatments, and that physicians indeed will be relied upon as primary care coordinators and supervisors.

The program is being rolled out in concert with major insurers. The insurers, who pay a fee to Walgreens, will identify diabetic patients for the chain. When patients go to Walgreens for supplies or a prescription, pharmacists will tell them about the program's availability and then attempt to enroll them.

If the store has a retail clinic, a nurse practitioner will offer counseling; otherwise, the pharmacist will conduct the sessions, Dr. Rosan explained. Both the pharmacists and the nurses have received training through a Joslin program certified by the Accreditation Council for Pharmacy Education.

The aim is to give patients four 30- to 60-minute sessions over a year-long period, with the potential of up to 12 interventions. Patients will pay nothing or a small copay for the sessions, Dr. Rosan said.

After each session, the counselor will fax, e-mail, or call the patient's primary care physician with information. “Our intent here is to make certain that this is not a fragmentation of the care,” said Dr. Rosan. If the primary caretaker is an endocrinologist, the counselor will reach out to that physician. For those who do not yet have a designated primary care physician, the pharmacies will make referrals.

Dr. Harrell also expressed reservations about Walgreens' potential conflict of interest. “The pharmacy has a certain secondary gain from having the patient in there,” he noted. For instance, the pharmacy could promote supplies or treatments that favor the pharmacy's bottom line but aren't necessarily the best fit for the patient.

Dr. Rosan acknowledges that there's an opportunity, at a minimum, to fill more prescriptions. It also expands Walgreens' growing role as a multiservice provider and gives it a chance to burnish its brand. “If we can help people get better outcomes, we think they'll have a tendency to use Walgreens more than other stores,” he said.

But the program may also help improve the nation's health if more diabetics take responsibility for managing their own care, he added.

Optimal Wellness won't be available to the uninsured, at least not initially. Walgreens is courting pharmaceutical companies to subsidize that effort. Walgreens' diabetes education effort is likely to expand nationally sooner rather than later. Many insurers are interested in the Optimal Wellness program, he said.

Walgreens, the nation's largest drug store chain, is dipping a toe into diabetes care by offering education and counseling in four metropolitan areas.

The company's Optimal Wellness program is based on the North Carolina Center for Pharmaceutical Care's diabetes project and also draws on a Walgreens pilot that was developed by the drug store chain and Harvard's Joslin Diabetes Center.

The program initially will be offered in Indianapolis, Phoenix, Albuquerque, and Oklahoma City. These areas were chosen partly because of the large number of diabetic residents, said Dr. Jay Rosan, senior vice president of health innovation at Take Care Health Systems, a Walgreens company.

Dr. Mack Harrell, chair of the socioeconomics and member advocacy committee for the American Association of Clinical Endocrinologists, said the Walgreens program could be helpful but that AACE believes that any assistance, education, or counseling should be supervised by physicians.

“I'm in favor of people getting all the education they need,” Dr. Harrell said in an interview. But, he added, “what we've learned from a number of recent studies is that the degree of glycemic control has to be individualized. You have to know the patient, know whether they have comorbidities that put them at higher risk, and decide what degree of control is acceptable.”

These nuances are beyond the capacity of a nurse practitioner and reinforce the need for a supervisory physician, he said.

Dr. Rosan emphasized that the nurse practitioners in the Optimal Wellness program will not offer treatments, and that physicians indeed will be relied upon as primary care coordinators and supervisors.

The program is being rolled out in concert with major insurers. The insurers, who pay a fee to Walgreens, will identify diabetic patients for the chain. When patients go to Walgreens for supplies or a prescription, pharmacists will tell them about the program's availability and then attempt to enroll them.

If the store has a retail clinic, a nurse practitioner will offer counseling; otherwise, the pharmacist will conduct the sessions, Dr. Rosan explained. Both the pharmacists and the nurses have received training through a Joslin program certified by the Accreditation Council for Pharmacy Education.

The aim is to give patients four 30- to 60-minute sessions over a year-long period, with the potential of up to 12 interventions. Patients will pay nothing or a small copay for the sessions, Dr. Rosan said.

After each session, the counselor will fax, e-mail, or call the patient's primary care physician with information. “Our intent here is to make certain that this is not a fragmentation of the care,” said Dr. Rosan. If the primary caretaker is an endocrinologist, the counselor will reach out to that physician. For those who do not yet have a designated primary care physician, the pharmacies will make referrals.

Dr. Harrell also expressed reservations about Walgreens' potential conflict of interest. “The pharmacy has a certain secondary gain from having the patient in there,” he noted. For instance, the pharmacy could promote supplies or treatments that favor the pharmacy's bottom line but aren't necessarily the best fit for the patient.

Dr. Rosan acknowledges that there's an opportunity, at a minimum, to fill more prescriptions. It also expands Walgreens' growing role as a multiservice provider and gives it a chance to burnish its brand. “If we can help people get better outcomes, we think they'll have a tendency to use Walgreens more than other stores,” he said.

But the program may also help improve the nation's health if more diabetics take responsibility for managing their own care, he added.

Optimal Wellness won't be available to the uninsured, at least not initially. Walgreens is courting pharmaceutical companies to subsidize that effort. Walgreens' diabetes education effort is likely to expand nationally sooner rather than later. Many insurers are interested in the Optimal Wellness program, he said.

Walgreens, the nation's largest drug store chain, is dipping a toe into diabetes care by offering education and counseling in four metropolitan areas.

The company's Optimal Wellness program is based on the North Carolina Center for Pharmaceutical Care's diabetes project and also draws on a Walgreens pilot that was developed by the drug store chain and Harvard's Joslin Diabetes Center.

The program initially will be offered in Indianapolis, Phoenix, Albuquerque, and Oklahoma City. These areas were chosen partly because of the large number of diabetic residents, said Dr. Jay Rosan, senior vice president of health innovation at Take Care Health Systems, a Walgreens company.

Dr. Mack Harrell, chair of the socioeconomics and member advocacy committee for the American Association of Clinical Endocrinologists, said the Walgreens program could be helpful but that AACE believes that any assistance, education, or counseling should be supervised by physicians.

“I'm in favor of people getting all the education they need,” Dr. Harrell said in an interview. But, he added, “what we've learned from a number of recent studies is that the degree of glycemic control has to be individualized. You have to know the patient, know whether they have comorbidities that put them at higher risk, and decide what degree of control is acceptable.”

These nuances are beyond the capacity of a nurse practitioner and reinforce the need for a supervisory physician, he said.

Dr. Rosan emphasized that the nurse practitioners in the Optimal Wellness program will not offer treatments, and that physicians indeed will be relied upon as primary care coordinators and supervisors.

The program is being rolled out in concert with major insurers. The insurers, who pay a fee to Walgreens, will identify diabetic patients for the chain. When patients go to Walgreens for supplies or a prescription, pharmacists will tell them about the program's availability and then attempt to enroll them.

If the store has a retail clinic, a nurse practitioner will offer counseling; otherwise, the pharmacist will conduct the sessions, Dr. Rosan explained. Both the pharmacists and the nurses have received training through a Joslin program certified by the Accreditation Council for Pharmacy Education.

The aim is to give patients four 30- to 60-minute sessions over a year-long period, with the potential of up to 12 interventions. Patients will pay nothing or a small copay for the sessions, Dr. Rosan said.

After each session, the counselor will fax, e-mail, or call the patient's primary care physician with information. “Our intent here is to make certain that this is not a fragmentation of the care,” said Dr. Rosan. If the primary caretaker is an endocrinologist, the counselor will reach out to that physician. For those who do not yet have a designated primary care physician, the pharmacies will make referrals.

Dr. Harrell also expressed reservations about Walgreens' potential conflict of interest. “The pharmacy has a certain secondary gain from having the patient in there,” he noted. For instance, the pharmacy could promote supplies or treatments that favor the pharmacy's bottom line but aren't necessarily the best fit for the patient.

Dr. Rosan acknowledges that there's an opportunity, at a minimum, to fill more prescriptions. It also expands Walgreens' growing role as a multiservice provider and gives it a chance to burnish its brand. “If we can help people get better outcomes, we think they'll have a tendency to use Walgreens more than other stores,” he said.

But the program may also help improve the nation's health if more diabetics take responsibility for managing their own care, he added.

Optimal Wellness won't be available to the uninsured, at least not initially. Walgreens is courting pharmaceutical companies to subsidize that effort. Walgreens' diabetes education effort is likely to expand nationally sooner rather than later. Many insurers are interested in the Optimal Wellness program, he said.

PhRMA Chief Resigning

Billy Tauzin, the president and chief executive officer of the Pharmaceutical Research and Manufacturers of America (PhRMA), announced in February that he will leave the trade association at the end of June. Mr. Tauzin noted in a statement that he took on the PhRMA role in 2005, shortly after a battle with cancer. “As the first ever cancer patient to lead PhRMA as its CEO, I now believe it is time I move on and hand the mantle of leadership of this great organization to others as passionate as myself, and to explore the many other interests I would like to pursue in this special second-chance life that I have been given,” Mr. Tauzin said. He also denied speculation that he was pushed out by PhRMA member companies unhappy with the deal that he made last year to support the Obama administration's health reform plan.

Big Market for Neurostimulation

Kalorama Information is predicting that within 5 years, the market for electrical and magnetic neurostimulation devices for treating depression could reach $16 billion a year. Currently, the market is limited because only one device is on the market, the vagus nerve stimulator made by Cyberonics Inc., and treatment with the device outweighs the cost of drug therapy, according to a report by the medical market research company. The analysis notes, however, that several manufacturers are developing external devices, such as Neuronetics Inc.'s repetitive TMS therapy system. Medtronic Inc., St. Jude Medical Inc., and the Boston Scientific Corp. are also looking into adapting their deep brain and spinal cord stimulators to depression treatment, Kalorama said.

Dissolvable Tobacco Info Sought

The Food and Drug Administration's Center for Tobacco Products got right to work after its launch last August. In February, the center sent letters to several tobacco companies, asking them to submit “a comprehensive and detailed summary” of research on their dissolvable smokeless tobacco products. The products “resemble candy,” according to the letters, and concerns about them include their use by people under age 26, potential misuse of the products, and accidental ingestion. The center said it wants the information to prepare for a meeting of the Tobacco Products Scientific Advisory Committee. The letters expressed concern “that children and adolescents may find dissolvable tobacco products particularly appealing, given the brightly colored packaging, candy-like appearance, and easily concealable size of many of these products.”

Depression Screening Backed

Physicians should strongly consider screening women for depression both during and after pregnancy, according to a new position statement from the American College of Obstetricians and Gynecologists. There are significant benefits to women and their families if depression is diagnosed and treated, the statement said (Obstet. Gynecol. 2010;115:394-5). ACOG estimates that 14%-23% of pregnant women experience depression symptoms and that 5%-25% of women experience postpartum depression. “With over 4 million births in the [United States] every year, we're talking about a huge number of women with postpartum depression–between 200,000 to more than 1 million each year,” Dr. Gerald F. Joseph, president of ACOG, said in a statement. The ACOG statement includes information on seven depression screening tools, each taking less than 10 minutes to perform. Practices should have a referral program in place for women who have depression symptoms.

Autism Research Gets Boost

The Obama administration is seeking $222 million in fiscal year 2011 to expand research into autism spectrum disorders. The funding, which would be disseminated through the Health and Human Services department, would focus on detection, treatment, and other activities with the potential to improve the lives of families affected by autism. The National Institutes of Health also is putting a focus on the disorder. The agency plans to undertake a complete genome sequencing and DNA analysis of 300 autism spectrum disorder cases. Officials at NIH are also planning to launch the first epigenomic studies of brain samples from individuals with autism spectrum disorders and those without the disorder. NIH will also investigate patterns of environmental exposure during pregnancy and the perinatal period.

IOM to Study LGBT Health Issues

The Institute of Medicine plans to review the state of science concerning the health of lesbian, gay, bisexual, and transgender (LGBT) people. An IOM committee will be charged with identifying knowledge gaps and outlining a specific research agenda for the National Institutes of Health. The committee is to examine LGBT health risks, health disparities, access to health care, and use of health care. Late last year, the Center for American Progress found in its own study that there are significant disparities when it comes to LGBT health status–for example, that lesbian, gay, and bisexual adults are twice as likely as heterosexual adults to experience psychological distress.

–Alicia Ault

PhRMA Chief Resigning

Billy Tauzin, the president and chief executive officer of the Pharmaceutical Research and Manufacturers of America (PhRMA), announced in February that he will leave the trade association at the end of June. Mr. Tauzin noted in a statement that he took on the PhRMA role in 2005, shortly after a battle with cancer. “As the first ever cancer patient to lead PhRMA as its CEO, I now believe it is time I move on and hand the mantle of leadership of this great organization to others as passionate as myself, and to explore the many other interests I would like to pursue in this special second-chance life that I have been given,” Mr. Tauzin said. He also denied speculation that he was pushed out by PhRMA member companies unhappy with the deal that he made last year to support the Obama administration's health reform plan.

Big Market for Neurostimulation

Kalorama Information is predicting that within 5 years, the market for electrical and magnetic neurostimulation devices for treating depression could reach $16 billion a year. Currently, the market is limited because only one device is on the market, the vagus nerve stimulator made by Cyberonics Inc., and treatment with the device outweighs the cost of drug therapy, according to a report by the medical market research company. The analysis notes, however, that several manufacturers are developing external devices, such as Neuronetics Inc.'s repetitive TMS therapy system. Medtronic Inc., St. Jude Medical Inc., and the Boston Scientific Corp. are also looking into adapting their deep brain and spinal cord stimulators to depression treatment, Kalorama said.

Dissolvable Tobacco Info Sought

The Food and Drug Administration's Center for Tobacco Products got right to work after its launch last August. In February, the center sent letters to several tobacco companies, asking them to submit “a comprehensive and detailed summary” of research on their dissolvable smokeless tobacco products. The products “resemble candy,” according to the letters, and concerns about them include their use by people under age 26, potential misuse of the products, and accidental ingestion. The center said it wants the information to prepare for a meeting of the Tobacco Products Scientific Advisory Committee. The letters expressed concern “that children and adolescents may find dissolvable tobacco products particularly appealing, given the brightly colored packaging, candy-like appearance, and easily concealable size of many of these products.”

Depression Screening Backed

Physicians should strongly consider screening women for depression both during and after pregnancy, according to a new position statement from the American College of Obstetricians and Gynecologists. There are significant benefits to women and their families if depression is diagnosed and treated, the statement said (Obstet. Gynecol. 2010;115:394-5). ACOG estimates that 14%-23% of pregnant women experience depression symptoms and that 5%-25% of women experience postpartum depression. “With over 4 million births in the [United States] every year, we're talking about a huge number of women with postpartum depression–between 200,000 to more than 1 million each year,” Dr. Gerald F. Joseph, president of ACOG, said in a statement. The ACOG statement includes information on seven depression screening tools, each taking less than 10 minutes to perform. Practices should have a referral program in place for women who have depression symptoms.

Autism Research Gets Boost

The Obama administration is seeking $222 million in fiscal year 2011 to expand research into autism spectrum disorders. The funding, which would be disseminated through the Health and Human Services department, would focus on detection, treatment, and other activities with the potential to improve the lives of families affected by autism. The National Institutes of Health also is putting a focus on the disorder. The agency plans to undertake a complete genome sequencing and DNA analysis of 300 autism spectrum disorder cases. Officials at NIH are also planning to launch the first epigenomic studies of brain samples from individuals with autism spectrum disorders and those without the disorder. NIH will also investigate patterns of environmental exposure during pregnancy and the perinatal period.

IOM to Study LGBT Health Issues

The Institute of Medicine plans to review the state of science concerning the health of lesbian, gay, bisexual, and transgender (LGBT) people. An IOM committee will be charged with identifying knowledge gaps and outlining a specific research agenda for the National Institutes of Health. The committee is to examine LGBT health risks, health disparities, access to health care, and use of health care. Late last year, the Center for American Progress found in its own study that there are significant disparities when it comes to LGBT health status–for example, that lesbian, gay, and bisexual adults are twice as likely as heterosexual adults to experience psychological distress.

–Alicia Ault

PhRMA Chief Resigning

Billy Tauzin, the president and chief executive officer of the Pharmaceutical Research and Manufacturers of America (PhRMA), announced in February that he will leave the trade association at the end of June. Mr. Tauzin noted in a statement that he took on the PhRMA role in 2005, shortly after a battle with cancer. “As the first ever cancer patient to lead PhRMA as its CEO, I now believe it is time I move on and hand the mantle of leadership of this great organization to others as passionate as myself, and to explore the many other interests I would like to pursue in this special second-chance life that I have been given,” Mr. Tauzin said. He also denied speculation that he was pushed out by PhRMA member companies unhappy with the deal that he made last year to support the Obama administration's health reform plan.

Big Market for Neurostimulation

Kalorama Information is predicting that within 5 years, the market for electrical and magnetic neurostimulation devices for treating depression could reach $16 billion a year. Currently, the market is limited because only one device is on the market, the vagus nerve stimulator made by Cyberonics Inc., and treatment with the device outweighs the cost of drug therapy, according to a report by the medical market research company. The analysis notes, however, that several manufacturers are developing external devices, such as Neuronetics Inc.'s repetitive TMS therapy system. Medtronic Inc., St. Jude Medical Inc., and the Boston Scientific Corp. are also looking into adapting their deep brain and spinal cord stimulators to depression treatment, Kalorama said.

Dissolvable Tobacco Info Sought

The Food and Drug Administration's Center for Tobacco Products got right to work after its launch last August. In February, the center sent letters to several tobacco companies, asking them to submit “a comprehensive and detailed summary” of research on their dissolvable smokeless tobacco products. The products “resemble candy,” according to the letters, and concerns about them include their use by people under age 26, potential misuse of the products, and accidental ingestion. The center said it wants the information to prepare for a meeting of the Tobacco Products Scientific Advisory Committee. The letters expressed concern “that children and adolescents may find dissolvable tobacco products particularly appealing, given the brightly colored packaging, candy-like appearance, and easily concealable size of many of these products.”

Depression Screening Backed

Physicians should strongly consider screening women for depression both during and after pregnancy, according to a new position statement from the American College of Obstetricians and Gynecologists. There are significant benefits to women and their families if depression is diagnosed and treated, the statement said (Obstet. Gynecol. 2010;115:394-5). ACOG estimates that 14%-23% of pregnant women experience depression symptoms and that 5%-25% of women experience postpartum depression. “With over 4 million births in the [United States] every year, we're talking about a huge number of women with postpartum depression–between 200,000 to more than 1 million each year,” Dr. Gerald F. Joseph, president of ACOG, said in a statement. The ACOG statement includes information on seven depression screening tools, each taking less than 10 minutes to perform. Practices should have a referral program in place for women who have depression symptoms.

Autism Research Gets Boost

The Obama administration is seeking $222 million in fiscal year 2011 to expand research into autism spectrum disorders. The funding, which would be disseminated through the Health and Human Services department, would focus on detection, treatment, and other activities with the potential to improve the lives of families affected by autism. The National Institutes of Health also is putting a focus on the disorder. The agency plans to undertake a complete genome sequencing and DNA analysis of 300 autism spectrum disorder cases. Officials at NIH are also planning to launch the first epigenomic studies of brain samples from individuals with autism spectrum disorders and those without the disorder. NIH will also investigate patterns of environmental exposure during pregnancy and the perinatal period.

IOM to Study LGBT Health Issues

The Institute of Medicine plans to review the state of science concerning the health of lesbian, gay, bisexual, and transgender (LGBT) people. An IOM committee will be charged with identifying knowledge gaps and outlining a specific research agenda for the National Institutes of Health. The committee is to examine LGBT health risks, health disparities, access to health care, and use of health care. Late last year, the Center for American Progress found in its own study that there are significant disparities when it comes to LGBT health status–for example, that lesbian, gay, and bisexual adults are twice as likely as heterosexual adults to experience psychological distress.

–Alicia Ault

The federal government has granted states and territories $119 million to reduce tobacco use, increase physical activity, and fight obesity, the Health and Human Services department announced.

The grants are funded by the American Recovery and Reinvestment Act, also known as the stimulus package.

The money will go to programs aimed at prevention and wellness and for intervening before people get sick, said HHS Secretary Kathleen Sebelius during a press conference.

“Prevention is a 'best buy' for health,” Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention, said during the press conference. His agency will help states implement the grants.

The awards were made in three major categories: policy and environmental changes; innovative programs; and tobacco cessation/telephone-based “quit-lines”.

All 50 states, as well as the District of Columbia and Puerto Rico, will receive funding to expand quit-lines. Dr. Frieden called the lines “highly cost effective.” He noted that tobacco-related disease is the number one cause of preventable death, and that two-thirds of smokers want to quit, but haven't found the right motivation or program.

Innovative programs in 13 states will be receiving money for 15 projects. Among those: Mississippi will receive $3 million to fund a statewide smoke-free air policy and Rhode Island will receive $3 million to fund a program to help elderly residents age at home. These programs will likely serve as models for other states, said Ms. Sebelius.

Other awards will go to help schools and communities support healthy food choices, to help support physical activity, and to promote breast-feeding, said Dr. Frieden.

More information about the awards are available at www.cdc.gov/chronicdisease/recovery/

The federal government has granted states and territories $119 million to reduce tobacco use, increase physical activity, and fight obesity, the Health and Human Services department announced.

The grants are funded by the American Recovery and Reinvestment Act, also known as the stimulus package.

The money will go to programs aimed at prevention and wellness and for intervening before people get sick, said HHS Secretary Kathleen Sebelius during a press conference.

“Prevention is a 'best buy' for health,” Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention, said during the press conference. His agency will help states implement the grants.

The awards were made in three major categories: policy and environmental changes; innovative programs; and tobacco cessation/telephone-based “quit-lines”.

All 50 states, as well as the District of Columbia and Puerto Rico, will receive funding to expand quit-lines. Dr. Frieden called the lines “highly cost effective.” He noted that tobacco-related disease is the number one cause of preventable death, and that two-thirds of smokers want to quit, but haven't found the right motivation or program.

Innovative programs in 13 states will be receiving money for 15 projects. Among those: Mississippi will receive $3 million to fund a statewide smoke-free air policy and Rhode Island will receive $3 million to fund a program to help elderly residents age at home. These programs will likely serve as models for other states, said Ms. Sebelius.

Other awards will go to help schools and communities support healthy food choices, to help support physical activity, and to promote breast-feeding, said Dr. Frieden.

More information about the awards are available at www.cdc.gov/chronicdisease/recovery/

The federal government has granted states and territories $119 million to reduce tobacco use, increase physical activity, and fight obesity, the Health and Human Services department announced.

The grants are funded by the American Recovery and Reinvestment Act, also known as the stimulus package.

The money will go to programs aimed at prevention and wellness and for intervening before people get sick, said HHS Secretary Kathleen Sebelius during a press conference.

“Prevention is a 'best buy' for health,” Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention, said during the press conference. His agency will help states implement the grants.

The awards were made in three major categories: policy and environmental changes; innovative programs; and tobacco cessation/telephone-based “quit-lines”.

All 50 states, as well as the District of Columbia and Puerto Rico, will receive funding to expand quit-lines. Dr. Frieden called the lines “highly cost effective.” He noted that tobacco-related disease is the number one cause of preventable death, and that two-thirds of smokers want to quit, but haven't found the right motivation or program.

Innovative programs in 13 states will be receiving money for 15 projects. Among those: Mississippi will receive $3 million to fund a statewide smoke-free air policy and Rhode Island will receive $3 million to fund a program to help elderly residents age at home. These programs will likely serve as models for other states, said Ms. Sebelius.

Other awards will go to help schools and communities support healthy food choices, to help support physical activity, and to promote breast-feeding, said Dr. Frieden.

More information about the awards are available at www.cdc.gov/chronicdisease/recovery/

Huge cutbacks in Medicare payment rates will likely cause many community-based cardiologists to close their private practices and become employees of hospitals instead, Dr. Jack Lewin, CEO of the American College of Cardiology, said in an interview.

Although a federal judge refused to hear a suit challenging the 2010 Medicare payment rates for cardiologists, the ACC said it will continue to fight what it considers to be an excessive and arbitrary reduction in fees.

The ACC filed a complaint in late December in the United States District Court for the Southern District of Florida, alleging that Health and Human Services Secretary Kathleen Sebelius illegally adopted the rates, using invalid survey data. Only a federal court would have jurisdiction over Medicare rates; the suit was filed in Florida because several of the plaintiffs reside in the state.

Among other issues, the ACC said that the Physician Practice Information Survey, which was used to collect practice expense data to set the 2010 rates, was inaccurate because it collected data from only 55 cardiologists, too few to be representative of the nation's cardiologists, alleged the suit.

The Department of Justice filed a motion to dismiss the suit, arguing that the Centers for Medicare and Medicaid Services' administrative expertise outweighed the court's judgment, and that the Florida district did not have jurisdiction.

Judge William Dimitrouleas agreed, and refused to hear the suit on Jan. 12.

The ACC was “deeply disappointed” by the refusal, Dr. Lewin said in a statement. He added, “What is deeply troubling about today's ruling is that it sets the precedent that CMS has complete and unchecked control over physician reimbursement for patient care even where its determinations are based on faulty data.”

Dr. Lewin said cardiologists aren't the only ones who will be affected. “Today's ruling should be a warning to all physicians that anyone is susceptible to falling into CMS's crosshairs unfairly and without recourse,” he said.

The ACC has not given up its fight, although it may now move from the courts back into Congress.

Medicare payments for all physicians are slated to be cut by 21% in 2010, as required by the sustainable growth rate (SGR) formula. Reductions could be as high as 30%-40% for cardiologists.

Fees are to be cut by 11% on average (in addition to the 21%), plus there will be reductions in imaging payments that will disproportionately affect cardiologists.

Currently, the mandated 21% SGR reduction is on hold until March 1. Congress approved a 2-month delay, tucking it into an appropriations bill for the U.S. Defense Department, which was signed into law by President Obama in late December.

However, cardiologists were hit with other reductions starting Jan. 1. Medicare payments for echocardiography are being cut by 11% and for stress testing by 8%. The cuts are slated to be even deeper going forward.

The agency also is slashing single-photon emission CT payments by 37%. The ACC collaborated on creating a new single code for SPECT and expected a phasing in of a reduced payment. Instead, it's coming in just 1 year.

Finally, starting Jan. 1, cardiologists and other specialists were no longer allowed to bill Medicare using inpatient or outpatient consultation codes. The CMS eliminated the codes as part of the 2010 fee schedule.

The American Association of Clinical Endocrinologists, the American Gastroenterological Association, and other providers have petitioned Congress to adopt an amendment introduced by Sen. Arlen Specter (D-Penn.) to delay that elimination for a year. The amendment was attached to the Senate health reform bill. At press time, House and Senate Democrats were still in negotiations over what would be included in the final health reform package.

In turn, that will reduce access to cardiologists and increase Medicare costs because hospital-based procedures are more expensive, he said. These are unintended consequences of “bad public policy,” Dr. Lewin said.

Indeed, practicing in the community is getting a lot tougher, said Dr. Tom Hill, a cardiologist in an eight-physician Muskegon, Mich.–based practice.

The cuts will “have a significant impact on our practice,” Dr. Hill said in an interview. He noted that Medicare revenue has already been flat to declining for the last decade, while expenses have been rising.

He and his partners are looking at options for reducing overhead, including eliminating staff positions. They've already instituted cuts in pay and benefits, and they may also have to reduce services.

For instance, the practice conducts 20-30 echocardiographic and nuclear stress tests at its office daily. The nuclear imaging reductions could amount to a 35% cut in income, and further cuts will come from the echo reductions.

More cardiologists in his region are joining hospitals to cope, he said.

“In some ways we're victims of our own success,” Dr. Hill said, noting that cardiologists have made strides in reducing cardiovascular morbidity and mortality. And yet, they are being repaid with lower fees, he said.

Across-the-board reductions don't take appropriateness or quality into account, Dr. Hill said. That does not change the incentives. “People already ordering tests inappropriately will just order more,” he said.

Huge cutbacks in Medicare payment rates will likely cause many community-based cardiologists to close their private practices and become employees of hospitals instead, Dr. Jack Lewin, CEO of the American College of Cardiology, said in an interview.

Although a federal judge refused to hear a suit challenging the 2010 Medicare payment rates for cardiologists, the ACC said it will continue to fight what it considers to be an excessive and arbitrary reduction in fees.

The ACC filed a complaint in late December in the United States District Court for the Southern District of Florida, alleging that Health and Human Services Secretary Kathleen Sebelius illegally adopted the rates, using invalid survey data. Only a federal court would have jurisdiction over Medicare rates; the suit was filed in Florida because several of the plaintiffs reside in the state.

Among other issues, the ACC said that the Physician Practice Information Survey, which was used to collect practice expense data to set the 2010 rates, was inaccurate because it collected data from only 55 cardiologists, too few to be representative of the nation's cardiologists, alleged the suit.

The Department of Justice filed a motion to dismiss the suit, arguing that the Centers for Medicare and Medicaid Services' administrative expertise outweighed the court's judgment, and that the Florida district did not have jurisdiction.

Judge William Dimitrouleas agreed, and refused to hear the suit on Jan. 12.

The ACC was “deeply disappointed” by the refusal, Dr. Lewin said in a statement. He added, “What is deeply troubling about today's ruling is that it sets the precedent that CMS has complete and unchecked control over physician reimbursement for patient care even where its determinations are based on faulty data.”

Dr. Lewin said cardiologists aren't the only ones who will be affected. “Today's ruling should be a warning to all physicians that anyone is susceptible to falling into CMS's crosshairs unfairly and without recourse,” he said.

The ACC has not given up its fight, although it may now move from the courts back into Congress.

Medicare payments for all physicians are slated to be cut by 21% in 2010, as required by the sustainable growth rate (SGR) formula. Reductions could be as high as 30%-40% for cardiologists.

Fees are to be cut by 11% on average (in addition to the 21%), plus there will be reductions in imaging payments that will disproportionately affect cardiologists.

Currently, the mandated 21% SGR reduction is on hold until March 1. Congress approved a 2-month delay, tucking it into an appropriations bill for the U.S. Defense Department, which was signed into law by President Obama in late December.

However, cardiologists were hit with other reductions starting Jan. 1. Medicare payments for echocardiography are being cut by 11% and for stress testing by 8%. The cuts are slated to be even deeper going forward.

The agency also is slashing single-photon emission CT payments by 37%. The ACC collaborated on creating a new single code for SPECT and expected a phasing in of a reduced payment. Instead, it's coming in just 1 year.

Finally, starting Jan. 1, cardiologists and other specialists were no longer allowed to bill Medicare using inpatient or outpatient consultation codes. The CMS eliminated the codes as part of the 2010 fee schedule.

The American Association of Clinical Endocrinologists, the American Gastroenterological Association, and other providers have petitioned Congress to adopt an amendment introduced by Sen. Arlen Specter (D-Penn.) to delay that elimination for a year. The amendment was attached to the Senate health reform bill. At press time, House and Senate Democrats were still in negotiations over what would be included in the final health reform package.

In turn, that will reduce access to cardiologists and increase Medicare costs because hospital-based procedures are more expensive, he said. These are unintended consequences of “bad public policy,” Dr. Lewin said.

Indeed, practicing in the community is getting a lot tougher, said Dr. Tom Hill, a cardiologist in an eight-physician Muskegon, Mich.–based practice.

The cuts will “have a significant impact on our practice,” Dr. Hill said in an interview. He noted that Medicare revenue has already been flat to declining for the last decade, while expenses have been rising.

He and his partners are looking at options for reducing overhead, including eliminating staff positions. They've already instituted cuts in pay and benefits, and they may also have to reduce services.

For instance, the practice conducts 20-30 echocardiographic and nuclear stress tests at its office daily. The nuclear imaging reductions could amount to a 35% cut in income, and further cuts will come from the echo reductions.

More cardiologists in his region are joining hospitals to cope, he said.

“In some ways we're victims of our own success,” Dr. Hill said, noting that cardiologists have made strides in reducing cardiovascular morbidity and mortality. And yet, they are being repaid with lower fees, he said.

Across-the-board reductions don't take appropriateness or quality into account, Dr. Hill said. That does not change the incentives. “People already ordering tests inappropriately will just order more,” he said.

Huge cutbacks in Medicare payment rates will likely cause many community-based cardiologists to close their private practices and become employees of hospitals instead, Dr. Jack Lewin, CEO of the American College of Cardiology, said in an interview.

Although a federal judge refused to hear a suit challenging the 2010 Medicare payment rates for cardiologists, the ACC said it will continue to fight what it considers to be an excessive and arbitrary reduction in fees.

The ACC filed a complaint in late December in the United States District Court for the Southern District of Florida, alleging that Health and Human Services Secretary Kathleen Sebelius illegally adopted the rates, using invalid survey data. Only a federal court would have jurisdiction over Medicare rates; the suit was filed in Florida because several of the plaintiffs reside in the state.

Among other issues, the ACC said that the Physician Practice Information Survey, which was used to collect practice expense data to set the 2010 rates, was inaccurate because it collected data from only 55 cardiologists, too few to be representative of the nation's cardiologists, alleged the suit.

The Department of Justice filed a motion to dismiss the suit, arguing that the Centers for Medicare and Medicaid Services' administrative expertise outweighed the court's judgment, and that the Florida district did not have jurisdiction.

Judge William Dimitrouleas agreed, and refused to hear the suit on Jan. 12.

The ACC was “deeply disappointed” by the refusal, Dr. Lewin said in a statement. He added, “What is deeply troubling about today's ruling is that it sets the precedent that CMS has complete and unchecked control over physician reimbursement for patient care even where its determinations are based on faulty data.”

Dr. Lewin said cardiologists aren't the only ones who will be affected. “Today's ruling should be a warning to all physicians that anyone is susceptible to falling into CMS's crosshairs unfairly and without recourse,” he said.

The ACC has not given up its fight, although it may now move from the courts back into Congress.

Medicare payments for all physicians are slated to be cut by 21% in 2010, as required by the sustainable growth rate (SGR) formula. Reductions could be as high as 30%-40% for cardiologists.

Fees are to be cut by 11% on average (in addition to the 21%), plus there will be reductions in imaging payments that will disproportionately affect cardiologists.

Currently, the mandated 21% SGR reduction is on hold until March 1. Congress approved a 2-month delay, tucking it into an appropriations bill for the U.S. Defense Department, which was signed into law by President Obama in late December.

However, cardiologists were hit with other reductions starting Jan. 1. Medicare payments for echocardiography are being cut by 11% and for stress testing by 8%. The cuts are slated to be even deeper going forward.

The agency also is slashing single-photon emission CT payments by 37%. The ACC collaborated on creating a new single code for SPECT and expected a phasing in of a reduced payment. Instead, it's coming in just 1 year.

Finally, starting Jan. 1, cardiologists and other specialists were no longer allowed to bill Medicare using inpatient or outpatient consultation codes. The CMS eliminated the codes as part of the 2010 fee schedule.

The American Association of Clinical Endocrinologists, the American Gastroenterological Association, and other providers have petitioned Congress to adopt an amendment introduced by Sen. Arlen Specter (D-Penn.) to delay that elimination for a year. The amendment was attached to the Senate health reform bill. At press time, House and Senate Democrats were still in negotiations over what would be included in the final health reform package.

In turn, that will reduce access to cardiologists and increase Medicare costs because hospital-based procedures are more expensive, he said. These are unintended consequences of “bad public policy,” Dr. Lewin said.

Indeed, practicing in the community is getting a lot tougher, said Dr. Tom Hill, a cardiologist in an eight-physician Muskegon, Mich.–based practice.

The cuts will “have a significant impact on our practice,” Dr. Hill said in an interview. He noted that Medicare revenue has already been flat to declining for the last decade, while expenses have been rising.

He and his partners are looking at options for reducing overhead, including eliminating staff positions. They've already instituted cuts in pay and benefits, and they may also have to reduce services.

For instance, the practice conducts 20-30 echocardiographic and nuclear stress tests at its office daily. The nuclear imaging reductions could amount to a 35% cut in income, and further cuts will come from the echo reductions.

More cardiologists in his region are joining hospitals to cope, he said.

“In some ways we're victims of our own success,” Dr. Hill said, noting that cardiologists have made strides in reducing cardiovascular morbidity and mortality. And yet, they are being repaid with lower fees, he said.

Across-the-board reductions don't take appropriateness or quality into account, Dr. Hill said. That does not change the incentives. “People already ordering tests inappropriately will just order more,” he said.

In what some observers are calling an unprecedented action, the Food and Drug Administration issued a letter of warning to a clinical investigator, Dr. Leslie S. Baumann, for having spoken to the media about an unapproved product. The letter could have a chilling effect on discussion of off-label uses or products in the pipeline.

The Division of Drug Marketing, Advertising, and Communications sent Dr. Baumann the letter on Jan. 11, noting that the agency "had become aware" of statements made to several outlets between 2007 and 2009 about the filler Dysport (abobotulinumtoxinA). At the time, Dysport was on the market in Europe but had not yet been approved in the United States.

The agency said that Dr. Baumann, a dermatologist in private practice in Miami, "promoted Dysport as safe and effective for the purposes for which it was/is being investigated, and otherwise promoted the drug as superior to an approved product."

This was a violation of FDA regulations largely because Dr. Baumann was an investigator in studies of Dysport, marketed by Medicis Pharmaceutical Corp., according to the agency.

The letter is "unprecedented," said Jeffrey Wasserstein, a director at the Washington, D.C.-based food and drug law firm Hyman, Phelps, and McNamara. Mr. Wasserstein said in an interview that, in the instances cited by the FDA, it appeared that Dr. Baumann was touting her own expertise, not acting on behalf of the company.

If Dr. Baumann was not speaking on behalf of the company or the trial, then she may have had the right to say what she wanted about the product, Mr. Wasserstein said. The letter - although not a formal warning from the agency - would still likely have a chilling effect on what individual physicians say about products in the future, he suggested.

Dr. David Goldberg, clinical professor of dermatology at Mt. Sinai Medical School in New York, agreed that the letter was unusual and said that he was not aware of any precedent in cosmetic dermatology. It's unclear whether Dr. Baumann's comments were promotional or just a reflection of her excitement about a new product. "It's a gray area," said Dr. Goldberg, who is also an adjunct professor at Fordham Law School in New York.

It is also not clear whether this was an isolated incident or if the FDA will embark on a new enforcement path, said Dr. Goldberg. Dysport is a drug, whereas most products in cosmetic dermatology are devices, he noted. Devices and drugs are regulated by two different branches of the FDA, with different regulatory approaches.

Dr. Goldberg said he would advise dermatologists that it is fine to continue to talk to the media about products in the pipeline but that they should be very careful about what they say. He disclosed that he, also, was an investigator on the Dysport trial.

Dr. Baumann's comments may have been viewed as too enthusiastic. The FDA cited Dr. Baumann for having spoken to Allure magazine in April 2007, Elle magazine in September 2007, and to NBC's "Today Show" on Jan. 8, 2009 in a segment titled, "Today's Health: Better Than Botox?" She was quoted by Elle, for instance, as saying, "I can't wait to use Reloxin, known in Europe as Dysport. This Botox alternative will be available in the U.S. next year. Effects last a month longer than Botox and, hopefully, it will cost less."

After receiving the letter, Dr. Baumann said that she met with FDA officials to discuss a potential resolution. On her attorney's advice, she is only commenting through her blog. In a statement, she said, "I applaud the FDA's focus on the safety and efficacy of drugs, and I have had a lengthy discussion with them about this matter, where I outlined the complexity of applying their rules and suggested some ideas for helping the FDA communicate its views to the medical research community."

Dr. Baumann also noted that she believes she is being held to a higher standard than physicians who do no clinical trials.

"This means, of course, that those doctors such as myself who have the most experience with the newest procedures and products will be able to say the least in public about them until FDA approval is issued," she wrote.

_{Dr. Baumann is a columnist for, and serves on the editorial advisory board of, Skin & Allergy News. EGMN and Skin & Allergy News are both owned by Elsevier.}

In what some observers are calling an unprecedented action, the Food and Drug Administration issued a letter of warning to a clinical investigator, Dr. Leslie S. Baumann, for having spoken to the media about an unapproved product. The letter could have a chilling effect on discussion of off-label uses or products in the pipeline.

The Division of Drug Marketing, Advertising, and Communications sent Dr. Baumann the letter on Jan. 11, noting that the agency "had become aware" of statements made to several outlets between 2007 and 2009 about the filler Dysport (abobotulinumtoxinA). At the time, Dysport was on the market in Europe but had not yet been approved in the United States.

The agency said that Dr. Baumann, a dermatologist in private practice in Miami, "promoted Dysport as safe and effective for the purposes for which it was/is being investigated, and otherwise promoted the drug as superior to an approved product."

This was a violation of FDA regulations largely because Dr. Baumann was an investigator in studies of Dysport, marketed by Medicis Pharmaceutical Corp., according to the agency.

The letter is "unprecedented," said Jeffrey Wasserstein, a director at the Washington, D.C.-based food and drug law firm Hyman, Phelps, and McNamara. Mr. Wasserstein said in an interview that, in the instances cited by the FDA, it appeared that Dr. Baumann was touting her own expertise, not acting on behalf of the company.

If Dr. Baumann was not speaking on behalf of the company or the trial, then she may have had the right to say what she wanted about the product, Mr. Wasserstein said. The letter - although not a formal warning from the agency - would still likely have a chilling effect on what individual physicians say about products in the future, he suggested.

Dr. David Goldberg, clinical professor of dermatology at Mt. Sinai Medical School in New York, agreed that the letter was unusual and said that he was not aware of any precedent in cosmetic dermatology. It's unclear whether Dr. Baumann's comments were promotional or just a reflection of her excitement about a new product. "It's a gray area," said Dr. Goldberg, who is also an adjunct professor at Fordham Law School in New York.

It is also not clear whether this was an isolated incident or if the FDA will embark on a new enforcement path, said Dr. Goldberg. Dysport is a drug, whereas most products in cosmetic dermatology are devices, he noted. Devices and drugs are regulated by two different branches of the FDA, with different regulatory approaches.

Dr. Goldberg said he would advise dermatologists that it is fine to continue to talk to the media about products in the pipeline but that they should be very careful about what they say. He disclosed that he, also, was an investigator on the Dysport trial.

Dr. Baumann's comments may have been viewed as too enthusiastic. The FDA cited Dr. Baumann for having spoken to Allure magazine in April 2007, Elle magazine in September 2007, and to NBC's "Today Show" on Jan. 8, 2009 in a segment titled, "Today's Health: Better Than Botox?" She was quoted by Elle, for instance, as saying, "I can't wait to use Reloxin, known in Europe as Dysport. This Botox alternative will be available in the U.S. next year. Effects last a month longer than Botox and, hopefully, it will cost less."

After receiving the letter, Dr. Baumann said that she met with FDA officials to discuss a potential resolution. On her attorney's advice, she is only commenting through her blog. In a statement, she said, "I applaud the FDA's focus on the safety and efficacy of drugs, and I have had a lengthy discussion with them about this matter, where I outlined the complexity of applying their rules and suggested some ideas for helping the FDA communicate its views to the medical research community."

Dr. Baumann also noted that she believes she is being held to a higher standard than physicians who do no clinical trials.

"This means, of course, that those doctors such as myself who have the most experience with the newest procedures and products will be able to say the least in public about them until FDA approval is issued," she wrote.

_{Dr. Baumann is a columnist for, and serves on the editorial advisory board of, Skin & Allergy News. EGMN and Skin & Allergy News are both owned by Elsevier.}

In what some observers are calling an unprecedented action, the Food and Drug Administration issued a letter of warning to a clinical investigator, Dr. Leslie S. Baumann, for having spoken to the media about an unapproved product. The letter could have a chilling effect on discussion of off-label uses or products in the pipeline.

The Division of Drug Marketing, Advertising, and Communications sent Dr. Baumann the letter on Jan. 11, noting that the agency "had become aware" of statements made to several outlets between 2007 and 2009 about the filler Dysport (abobotulinumtoxinA). At the time, Dysport was on the market in Europe but had not yet been approved in the United States.

The agency said that Dr. Baumann, a dermatologist in private practice in Miami, "promoted Dysport as safe and effective for the purposes for which it was/is being investigated, and otherwise promoted the drug as superior to an approved product."

This was a violation of FDA regulations largely because Dr. Baumann was an investigator in studies of Dysport, marketed by Medicis Pharmaceutical Corp., according to the agency.

The letter is "unprecedented," said Jeffrey Wasserstein, a director at the Washington, D.C.-based food and drug law firm Hyman, Phelps, and McNamara. Mr. Wasserstein said in an interview that, in the instances cited by the FDA, it appeared that Dr. Baumann was touting her own expertise, not acting on behalf of the company.

If Dr. Baumann was not speaking on behalf of the company or the trial, then she may have had the right to say what she wanted about the product, Mr. Wasserstein said. The letter - although not a formal warning from the agency - would still likely have a chilling effect on what individual physicians say about products in the future, he suggested.

Dr. David Goldberg, clinical professor of dermatology at Mt. Sinai Medical School in New York, agreed that the letter was unusual and said that he was not aware of any precedent in cosmetic dermatology. It's unclear whether Dr. Baumann's comments were promotional or just a reflection of her excitement about a new product. "It's a gray area," said Dr. Goldberg, who is also an adjunct professor at Fordham Law School in New York.

It is also not clear whether this was an isolated incident or if the FDA will embark on a new enforcement path, said Dr. Goldberg. Dysport is a drug, whereas most products in cosmetic dermatology are devices, he noted. Devices and drugs are regulated by two different branches of the FDA, with different regulatory approaches.

Dr. Goldberg said he would advise dermatologists that it is fine to continue to talk to the media about products in the pipeline but that they should be very careful about what they say. He disclosed that he, also, was an investigator on the Dysport trial.

Dr. Baumann's comments may have been viewed as too enthusiastic. The FDA cited Dr. Baumann for having spoken to Allure magazine in April 2007, Elle magazine in September 2007, and to NBC's "Today Show" on Jan. 8, 2009 in a segment titled, "Today's Health: Better Than Botox?" She was quoted by Elle, for instance, as saying, "I can't wait to use Reloxin, known in Europe as Dysport. This Botox alternative will be available in the U.S. next year. Effects last a month longer than Botox and, hopefully, it will cost less."

After receiving the letter, Dr. Baumann said that she met with FDA officials to discuss a potential resolution. On her attorney's advice, she is only commenting through her blog. In a statement, she said, "I applaud the FDA's focus on the safety and efficacy of drugs, and I have had a lengthy discussion with them about this matter, where I outlined the complexity of applying their rules and suggested some ideas for helping the FDA communicate its views to the medical research community."

Dr. Baumann also noted that she believes she is being held to a higher standard than physicians who do no clinical trials.

"This means, of course, that those doctors such as myself who have the most experience with the newest procedures and products will be able to say the least in public about them until FDA approval is issued," she wrote.

_{Dr. Baumann is a columnist for, and serves on the editorial advisory board of, Skin & Allergy News. EGMN and Skin & Allergy News are both owned by Elsevier.}

The Federal Trade Commission has obtained a settlement from the Indoor Tanning Association in which the industry group has agreed that it will no longer make false health and safety claims about indoor tanning.

The tentative settlement was approved by commissioners in late January by a vote of 4-0. The agency opened the agreement for public comments until Feb. 26. After that, the FTC will decide whether to make the settlement final.

The American Academy of Dermatology (AAD) applauded the action, noting that it had complained to the FTC in the wake of an advertising campaign launched by the Indoor Tanning Association (ITA) in March 2008. That campaign made a number of false claims, according to the FTC. Among them: that indoor tanning is approved by the government; that it is safer than outdoor tanning; and that vitamin D supplements may impair immunity.

The ITA ad campaign also claimed that the National Academy of Sciences had determined that "the risks of not getting enough ultraviolet light far outweigh the hypothetical risk of skin cancer."

"The messages promoted by the indoor tanning industry fly in the face of scientific evidence," said David C. Vladeck, director of the FTC's Bureau of Consumer Protection in a statement announcing the settlement.

Dr. David M. Pariser, president of the AAD, noted that the FTC's settlement comes at a good time "because many individuals may be using indoor tanning facilities during the winter months under the false impression that this is a safe way to generate their bodies' production of vitamin D, as has been claimed by the industry in its advertising."

The Melanoma Research Foundation said in a statement that "the settlement also reiterates the need for clear and fact-based guidelines for tanning devices."

According to the draft settlement, ITA is prohibited from "making the misrepresentations challenged in the complaint, from misrepresenting any tests or studies, and from providing deceptive advertisements to its members."

Future ads must make certain disclosures. Ads that make claims about health benefits or safety of indoor tanning have to say: "Exposure to ultraviolet radiation may increase the likelihood of developing skin cancer and can cause serious eye injury."

According to the draft settlement, any advertisement that makes a claims about vitamin D must say: "You do not need to become tan for your skin to make vitamin D. Exposure to ultraviolet radiation may increase the likelihood of developing skin cancer and can cause serious eye injury."

The FTC also posted an alert for consumers on its Web site, explaining the myths contained in the ad campaign.

In a statement after the settlement, the ITA reiterated that it had not been found guilty. "As the FTC's consent order states, the settlement agreement is for settlement purposes only and does not constitute an admission by the ITA that it made misrepresentations or violated any law," according to a statement from the association.

The settlement applies only to the ITA and its actions. It does not apply to the thousands of individual tanning bed operators. However, the Food and Drug Administration is taking a closer look at tanning bed risks. Its General and Plastic Surgery Devices Panel is scheduled to meet Mar. 25 to consider whether changes need to be made to tanning bed warnings.

The Federal Trade Commission has obtained a settlement from the Indoor Tanning Association in which the industry group has agreed that it will no longer make false health and safety claims about indoor tanning.

The tentative settlement was approved by commissioners in late January by a vote of 4-0. The agency opened the agreement for public comments until Feb. 26. After that, the FTC will decide whether to make the settlement final.

The American Academy of Dermatology (AAD) applauded the action, noting that it had complained to the FTC in the wake of an advertising campaign launched by the Indoor Tanning Association (ITA) in March 2008. That campaign made a number of false claims, according to the FTC. Among them: that indoor tanning is approved by the government; that it is safer than outdoor tanning; and that vitamin D supplements may impair immunity.

The ITA ad campaign also claimed that the National Academy of Sciences had determined that "the risks of not getting enough ultraviolet light far outweigh the hypothetical risk of skin cancer."

"The messages promoted by the indoor tanning industry fly in the face of scientific evidence," said David C. Vladeck, director of the FTC's Bureau of Consumer Protection in a statement announcing the settlement.

Dr. David M. Pariser, president of the AAD, noted that the FTC's settlement comes at a good time "because many individuals may be using indoor tanning facilities during the winter months under the false impression that this is a safe way to generate their bodies' production of vitamin D, as has been claimed by the industry in its advertising."

The Melanoma Research Foundation said in a statement that "the settlement also reiterates the need for clear and fact-based guidelines for tanning devices."

According to the draft settlement, ITA is prohibited from "making the misrepresentations challenged in the complaint, from misrepresenting any tests or studies, and from providing deceptive advertisements to its members."

Future ads must make certain disclosures. Ads that make claims about health benefits or safety of indoor tanning have to say: "Exposure to ultraviolet radiation may increase the likelihood of developing skin cancer and can cause serious eye injury."

According to the draft settlement, any advertisement that makes a claims about vitamin D must say: "You do not need to become tan for your skin to make vitamin D. Exposure to ultraviolet radiation may increase the likelihood of developing skin cancer and can cause serious eye injury."

The FTC also posted an alert for consumers on its Web site, explaining the myths contained in the ad campaign.

In a statement after the settlement, the ITA reiterated that it had not been found guilty. "As the FTC's consent order states, the settlement agreement is for settlement purposes only and does not constitute an admission by the ITA that it made misrepresentations or violated any law," according to a statement from the association.

The settlement applies only to the ITA and its actions. It does not apply to the thousands of individual tanning bed operators. However, the Food and Drug Administration is taking a closer look at tanning bed risks. Its General and Plastic Surgery Devices Panel is scheduled to meet Mar. 25 to consider whether changes need to be made to tanning bed warnings.

The Federal Trade Commission has obtained a settlement from the Indoor Tanning Association in which the industry group has agreed that it will no longer make false health and safety claims about indoor tanning.

The tentative settlement was approved by commissioners in late January by a vote of 4-0. The agency opened the agreement for public comments until Feb. 26. After that, the FTC will decide whether to make the settlement final.

The American Academy of Dermatology (AAD) applauded the action, noting that it had complained to the FTC in the wake of an advertising campaign launched by the Indoor Tanning Association (ITA) in March 2008. That campaign made a number of false claims, according to the FTC. Among them: that indoor tanning is approved by the government; that it is safer than outdoor tanning; and that vitamin D supplements may impair immunity.

The ITA ad campaign also claimed that the National Academy of Sciences had determined that "the risks of not getting enough ultraviolet light far outweigh the hypothetical risk of skin cancer."

"The messages promoted by the indoor tanning industry fly in the face of scientific evidence," said David C. Vladeck, director of the FTC's Bureau of Consumer Protection in a statement announcing the settlement.

Dr. David M. Pariser, president of the AAD, noted that the FTC's settlement comes at a good time "because many individuals may be using indoor tanning facilities during the winter months under the false impression that this is a safe way to generate their bodies' production of vitamin D, as has been claimed by the industry in its advertising."

The Melanoma Research Foundation said in a statement that "the settlement also reiterates the need for clear and fact-based guidelines for tanning devices."

According to the draft settlement, ITA is prohibited from "making the misrepresentations challenged in the complaint, from misrepresenting any tests or studies, and from providing deceptive advertisements to its members."

Future ads must make certain disclosures. Ads that make claims about health benefits or safety of indoor tanning have to say: "Exposure to ultraviolet radiation may increase the likelihood of developing skin cancer and can cause serious eye injury."

According to the draft settlement, any advertisement that makes a claims about vitamin D must say: "You do not need to become tan for your skin to make vitamin D. Exposure to ultraviolet radiation may increase the likelihood of developing skin cancer and can cause serious eye injury."

The FTC also posted an alert for consumers on its Web site, explaining the myths contained in the ad campaign.

In a statement after the settlement, the ITA reiterated that it had not been found guilty. "As the FTC's consent order states, the settlement agreement is for settlement purposes only and does not constitute an admission by the ITA that it made misrepresentations or violated any law," according to a statement from the association.

The settlement applies only to the ITA and its actions. It does not apply to the thousands of individual tanning bed operators. However, the Food and Drug Administration is taking a closer look at tanning bed risks. Its General and Plastic Surgery Devices Panel is scheduled to meet Mar. 25 to consider whether changes need to be made to tanning bed warnings.

The Food and Drug Administration announced that it has chosen Harvard Pilgrim Health Care Inc. to design a pilot of a new safety monitoring system.

The agency said that the program, called the Sentinel System, will help it keep closer tabs on safety problems because it will analyze information collected during routine health care. The system will allow the agency to collect data on drugs and devices at the source—from medical records. For instance, if the agency knew that a device or drug had been linked to cardiac side effects, FDA safety officers could query the Sentinel System to see if such problems had arisen.

Congress required the FDA to develop such a safety system as part of the Food and Drug Administration Amendments Act of 2007. It was also recommended by the Institute of Medicine in a 2006 report on drug safety.

“Once operational, the Sentinel System will help us find answers to important drug safety questions, leading to stronger safeguards for public health, while still protecting the privacy and security of individual health information,” said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, in a statement.

The Food and Drug Administration announced that it has chosen Harvard Pilgrim Health Care Inc. to design a pilot of a new safety monitoring system.

The agency said that the program, called the Sentinel System, will help it keep closer tabs on safety problems because it will analyze information collected during routine health care. The system will allow the agency to collect data on drugs and devices at the source—from medical records. For instance, if the agency knew that a device or drug had been linked to cardiac side effects, FDA safety officers could query the Sentinel System to see if such problems had arisen.

Congress required the FDA to develop such a safety system as part of the Food and Drug Administration Amendments Act of 2007. It was also recommended by the Institute of Medicine in a 2006 report on drug safety.

“Once operational, the Sentinel System will help us find answers to important drug safety questions, leading to stronger safeguards for public health, while still protecting the privacy and security of individual health information,” said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, in a statement.

The Food and Drug Administration announced that it has chosen Harvard Pilgrim Health Care Inc. to design a pilot of a new safety monitoring system.

The agency said that the program, called the Sentinel System, will help it keep closer tabs on safety problems because it will analyze information collected during routine health care. The system will allow the agency to collect data on drugs and devices at the source—from medical records. For instance, if the agency knew that a device or drug had been linked to cardiac side effects, FDA safety officers could query the Sentinel System to see if such problems had arisen.

Congress required the FDA to develop such a safety system as part of the Food and Drug Administration Amendments Act of 2007. It was also recommended by the Institute of Medicine in a 2006 report on drug safety.

“Once operational, the Sentinel System will help us find answers to important drug safety questions, leading to stronger safeguards for public health, while still protecting the privacy and security of individual health information,” said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, in a statement.

The Food and Drug Administration has chosen Harvard Pilgrim Health Care Inc. to design a pilot of a new safety monitoring system.

The agency announced that the program, called the Sentinel System, will help it keep closer tabs on safety problems because it will analyze information collected during routine health care. The Sentinel System will allow the agency to collect data on drugs and devices at the source—from medical records. For instance, if the agency knew that a device or drug had been linked to cardiac side effects, FDA safety officers could query the Sentinel System for such problems.

Congress required the FDA to develop such a safety system as part of the Food and Drug Administration Amendments Act of 2007. It was also recommended by the Institute of Medicine in a 2006 report on drug safety.

“The FDA has been doing the groundwork for a nationwide Sentinel System,” said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, in a statement. “Once operational, [it[will help us find answers to important drug safety questions, leading to stronger safeguards for public health, while still protecting the privacy and security of individual health information,” she said.

The system has been under development for almost 2 years; the agency held yet another workshop with potential participants on Jan. 11.

Harvard Pilgrim, a Wellesley, Mass.–based health plan, was given a 1-year contract to establish a coordinating center. This scaled-down version of the planned Sentinal System will “identify appropriate databases, develop a scientific framework for obtaining real-time data, and ensure data quality,” according to an FDA press release.

The Food and Drug Administration has chosen Harvard Pilgrim Health Care Inc. to design a pilot of a new safety monitoring system.

The agency announced that the program, called the Sentinel System, will help it keep closer tabs on safety problems because it will analyze information collected during routine health care. The Sentinel System will allow the agency to collect data on drugs and devices at the source—from medical records. For instance, if the agency knew that a device or drug had been linked to cardiac side effects, FDA safety officers could query the Sentinel System for such problems.

Congress required the FDA to develop such a safety system as part of the Food and Drug Administration Amendments Act of 2007. It was also recommended by the Institute of Medicine in a 2006 report on drug safety.

“The FDA has been doing the groundwork for a nationwide Sentinel System,” said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, in a statement. “Once operational, [it[will help us find answers to important drug safety questions, leading to stronger safeguards for public health, while still protecting the privacy and security of individual health information,” she said.

The system has been under development for almost 2 years; the agency held yet another workshop with potential participants on Jan. 11.

Harvard Pilgrim, a Wellesley, Mass.–based health plan, was given a 1-year contract to establish a coordinating center. This scaled-down version of the planned Sentinal System will “identify appropriate databases, develop a scientific framework for obtaining real-time data, and ensure data quality,” according to an FDA press release.

The Food and Drug Administration has chosen Harvard Pilgrim Health Care Inc. to design a pilot of a new safety monitoring system.

The agency announced that the program, called the Sentinel System, will help it keep closer tabs on safety problems because it will analyze information collected during routine health care. The Sentinel System will allow the agency to collect data on drugs and devices at the source—from medical records. For instance, if the agency knew that a device or drug had been linked to cardiac side effects, FDA safety officers could query the Sentinel System for such problems.

Congress required the FDA to develop such a safety system as part of the Food and Drug Administration Amendments Act of 2007. It was also recommended by the Institute of Medicine in a 2006 report on drug safety.

“The FDA has been doing the groundwork for a nationwide Sentinel System,” said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, in a statement. “Once operational, [it[will help us find answers to important drug safety questions, leading to stronger safeguards for public health, while still protecting the privacy and security of individual health information,” she said.

The system has been under development for almost 2 years; the agency held yet another workshop with potential participants on Jan. 11.

Harvard Pilgrim, a Wellesley, Mass.–based health plan, was given a 1-year contract to establish a coordinating center. This scaled-down version of the planned Sentinal System will “identify appropriate databases, develop a scientific framework for obtaining real-time data, and ensure data quality,” according to an FDA press release.

FDA Names New Device Chief

The Food and Drug Administration has named a new permanent head of the Center for Devices and Radiological Health. Dr. Jeffrey Shuren, who has been acting director since early September, will now direct the center. He replaces Dr. Daniel Schultz, who resigned last year after critics claimed he was too cozy with medical device makers. In a statement, the head of the device industry trade group Advanced Medical Technology Association (AdvaMed) applauded Dr. Shuren's appointment and said that he has already shown effective leadership skills. “His more than 10 years experience at FDA, in various high-level policy and planning positions within the commissioner's office, will serve him well as he takes control of an organization that oversees such a wide range of life-saving and life-enhancing products,” said AdvaMed CEO Stephen J. Ubl. The center also unveiled its strategic plan for 2010, with four priority areas: effectively regulating products throughout their development and marketing; enhancing communication and transparency; strengthening the center's workforce and workplace; and spurring innovation and addressing unmet public health needs. The strategic plan is available at

www.fda.gov/medicaldevices

Access to Specialists a Problem

The Agency for Healthcare Research and Quality reports that 1 in 13 American adults who needed to see a specialist in 2007 said that getting access was a “big problem.” The data come from the Medical Expenditure Panel Survey. The survey found that 16% of adults without primary care physicians had problems accessing specialists, compared with 6% of those who had a usual source of primary care. Nonelderly uninsured adults had the most difficulty getting in to see a specialist, followed by nonelderly adults with public health coverage and those with private insurance. More data are available in the agency's report, “Variations in Perceived Need and Access to Specialty Care Among Adults in the U.S. Civilian Noninstitutionalized Population, 2007,” available at

www.meps.ahrq.gov/mepsweb/data_files/publications/st274/stat274.pdf

'Extraordinary' Drug Price Hikes

The Government Accountability Office said that 416 brand-name pharmaceutical products had “extraordinary” price increases from 2000 to 2008. While this represents only 0.5% of all brand-name products, most of the increases ranged from 100% to 499%, the GAO said in a report released in early January (GAO-10–201). More than half of those products were in three therapeutic classes: central nervous system, anti-infective, and cardiovascular. One possible reason for the price inflation, said the agency: The drugs are bought from wholesalers, repackaged, and resold at higher prices to physicians or hospitals. The Pharmaceutical Research and Manufacturers of America (PhRMA) industry group said that the report “focuses only on a small number of selected brand medicines rather than the entire prescription drug market.”

FDA Okayed 26 New Meds in 2009

The FDA approved 19 new chemical entities and 7 new biologics in 2009, according to Washington Analysis, a Washington–based investment adviser. Among the new chemical entities were Eli Lilly's oral platelet inhibitor Effient (prasugrel) and Sanofi-Aventis's antiarrhythmic drug Multaq (dronedarone). In his report, Washington Analysis' Ira Loss said that he expected more approvals this year because the agency claimed it wouldn't let statutory approval dates be overridden and it received more money for reviews.

Tobacco Prevention Funds Cut

Many states are severely cutting back on funding for tobacco use prevention programs, despite having collected huge revenues from taxes and the 1998 tobacco settlement, according to a report sponsored by the Campaign for Tobacco-Free Kids, American Heart Association, American Cancer Society Cancer Action Network, American Lung Association, and the Robert Wood Johnson Foundation. Overall, states will collect $25 billion in fiscal year 2010 but will spend only $567 million (2%) on prevention and cessation programs, the report said. Only North Dakota funds programs at the amount recommended by the Centers for Disease Control and Prevention; 31 states provide less than a quarter of the recommended level.

FDA Names New Device Chief

The Food and Drug Administration has named a new permanent head of the Center for Devices and Radiological Health. Dr. Jeffrey Shuren, who has been acting director since early September, will now direct the center. He replaces Dr. Daniel Schultz, who resigned last year after critics claimed he was too cozy with medical device makers. In a statement, the head of the device industry trade group Advanced Medical Technology Association (AdvaMed) applauded Dr. Shuren's appointment and said that he has already shown effective leadership skills. “His more than 10 years experience at FDA, in various high-level policy and planning positions within the commissioner's office, will serve him well as he takes control of an organization that oversees such a wide range of life-saving and life-enhancing products,” said AdvaMed CEO Stephen J. Ubl. The center also unveiled its strategic plan for 2010, with four priority areas: effectively regulating products throughout their development and marketing; enhancing communication and transparency; strengthening the center's workforce and workplace; and spurring innovation and addressing unmet public health needs. The strategic plan is available at

www.fda.gov/medicaldevices

Access to Specialists a Problem

The Agency for Healthcare Research and Quality reports that 1 in 13 American adults who needed to see a specialist in 2007 said that getting access was a “big problem.” The data come from the Medical Expenditure Panel Survey. The survey found that 16% of adults without primary care physicians had problems accessing specialists, compared with 6% of those who had a usual source of primary care. Nonelderly uninsured adults had the most difficulty getting in to see a specialist, followed by nonelderly adults with public health coverage and those with private insurance. More data are available in the agency's report, “Variations in Perceived Need and Access to Specialty Care Among Adults in the U.S. Civilian Noninstitutionalized Population, 2007,” available at

www.meps.ahrq.gov/mepsweb/data_files/publications/st274/stat274.pdf

'Extraordinary' Drug Price Hikes

The Government Accountability Office said that 416 brand-name pharmaceutical products had “extraordinary” price increases from 2000 to 2008. While this represents only 0.5% of all brand-name products, most of the increases ranged from 100% to 499%, the GAO said in a report released in early January (GAO-10–201). More than half of those products were in three therapeutic classes: central nervous system, anti-infective, and cardiovascular. One possible reason for the price inflation, said the agency: The drugs are bought from wholesalers, repackaged, and resold at higher prices to physicians or hospitals. The Pharmaceutical Research and Manufacturers of America (PhRMA) industry group said that the report “focuses only on a small number of selected brand medicines rather than the entire prescription drug market.”

FDA Okayed 26 New Meds in 2009

The FDA approved 19 new chemical entities and 7 new biologics in 2009, according to Washington Analysis, a Washington–based investment adviser. Among the new chemical entities were Eli Lilly's oral platelet inhibitor Effient (prasugrel) and Sanofi-Aventis's antiarrhythmic drug Multaq (dronedarone). In his report, Washington Analysis' Ira Loss said that he expected more approvals this year because the agency claimed it wouldn't let statutory approval dates be overridden and it received more money for reviews.

Tobacco Prevention Funds Cut

Many states are severely cutting back on funding for tobacco use prevention programs, despite having collected huge revenues from taxes and the 1998 tobacco settlement, according to a report sponsored by the Campaign for Tobacco-Free Kids, American Heart Association, American Cancer Society Cancer Action Network, American Lung Association, and the Robert Wood Johnson Foundation. Overall, states will collect $25 billion in fiscal year 2010 but will spend only $567 million (2%) on prevention and cessation programs, the report said. Only North Dakota funds programs at the amount recommended by the Centers for Disease Control and Prevention; 31 states provide less than a quarter of the recommended level.

FDA Names New Device Chief

The Food and Drug Administration has named a new permanent head of the Center for Devices and Radiological Health. Dr. Jeffrey Shuren, who has been acting director since early September, will now direct the center. He replaces Dr. Daniel Schultz, who resigned last year after critics claimed he was too cozy with medical device makers. In a statement, the head of the device industry trade group Advanced Medical Technology Association (AdvaMed) applauded Dr. Shuren's appointment and said that he has already shown effective leadership skills. “His more than 10 years experience at FDA, in various high-level policy and planning positions within the commissioner's office, will serve him well as he takes control of an organization that oversees such a wide range of life-saving and life-enhancing products,” said AdvaMed CEO Stephen J. Ubl. The center also unveiled its strategic plan for 2010, with four priority areas: effectively regulating products throughout their development and marketing; enhancing communication and transparency; strengthening the center's workforce and workplace; and spurring innovation and addressing unmet public health needs. The strategic plan is available at

www.fda.gov/medicaldevices

Access to Specialists a Problem

The Agency for Healthcare Research and Quality reports that 1 in 13 American adults who needed to see a specialist in 2007 said that getting access was a “big problem.” The data come from the Medical Expenditure Panel Survey. The survey found that 16% of adults without primary care physicians had problems accessing specialists, compared with 6% of those who had a usual source of primary care. Nonelderly uninsured adults had the most difficulty getting in to see a specialist, followed by nonelderly adults with public health coverage and those with private insurance. More data are available in the agency's report, “Variations in Perceived Need and Access to Specialty Care Among Adults in the U.S. Civilian Noninstitutionalized Population, 2007,” available at

www.meps.ahrq.gov/mepsweb/data_files/publications/st274/stat274.pdf

'Extraordinary' Drug Price Hikes

The Government Accountability Office said that 416 brand-name pharmaceutical products had “extraordinary” price increases from 2000 to 2008. While this represents only 0.5% of all brand-name products, most of the increases ranged from 100% to 499%, the GAO said in a report released in early January (GAO-10–201). More than half of those products were in three therapeutic classes: central nervous system, anti-infective, and cardiovascular. One possible reason for the price inflation, said the agency: The drugs are bought from wholesalers, repackaged, and resold at higher prices to physicians or hospitals. The Pharmaceutical Research and Manufacturers of America (PhRMA) industry group said that the report “focuses only on a small number of selected brand medicines rather than the entire prescription drug market.”

FDA Okayed 26 New Meds in 2009

The FDA approved 19 new chemical entities and 7 new biologics in 2009, according to Washington Analysis, a Washington–based investment adviser. Among the new chemical entities were Eli Lilly's oral platelet inhibitor Effient (prasugrel) and Sanofi-Aventis's antiarrhythmic drug Multaq (dronedarone). In his report, Washington Analysis' Ira Loss said that he expected more approvals this year because the agency claimed it wouldn't let statutory approval dates be overridden and it received more money for reviews.

Tobacco Prevention Funds Cut

Many states are severely cutting back on funding for tobacco use prevention programs, despite having collected huge revenues from taxes and the 1998 tobacco settlement, according to a report sponsored by the Campaign for Tobacco-Free Kids, American Heart Association, American Cancer Society Cancer Action Network, American Lung Association, and the Robert Wood Johnson Foundation. Overall, states will collect $25 billion in fiscal year 2010 but will spend only $567 million (2%) on prevention and cessation programs, the report said. Only North Dakota funds programs at the amount recommended by the Centers for Disease Control and Prevention; 31 states provide less than a quarter of the recommended level.