Elizabeth Mechcatie

SILVER SPRING, Md. – A federal advisory panel on Jan. 12 voted 7 to 4, with 1 abstention, that the potential risks of liprotamase, a genetically engineered pancreatic enzyme formulation, outweighed its benefits as a treatment for exocrine pancreatic insufficiency.

Liprotamase – which contains lipase, protease, and amylase and is available in capsule form and in one strength only – is being reviewed by the Food and Drug Administration for the treatment for patients with exocrine pancreatic insufficiency (EPI) caused by cystic fibrosis (CF), chronic pancreatitis (CP), pancreatectomy, or other conditions that limit or impair function of the pancreas; this indication was proposed by the manufacturer, Alnara Pharmaceuticals. If approved, liprotamase would be the first nonporcine-derived pancreatic enzyme therapy available in the United States. Porcine-derived pancreatic enzyme products have been available for years; currently, three such products are approved.

At the meeting of FDA’s Gastrointestinal Drugs Advisory Committee, the majority of the panelists agreed that the data from the pivotal trial, which compared liprotamase (32,000 U) per meal to placebo in 138 patients with CF-related EPI over 6 weeks did not provide enough evidence for efficacy. The primary end point was changes from baseline in the coefficient of fat absorption (CFA), a measure of the amount of dietary fat absorbed that has been accepted as a surrogate end point for the porcine-derived products, because an increase in fat absorption has been associated with improvements in clinical outcomes.

In the study, the CFA increased by 11% among those on treatment, compared with 0.2% among those on placebo. The panel voted 10 to 1, with 1 abstention, that the magnitude of the change in CFA among those on liprotamase was not sufficient to be clinically meaningful. Panelists also observed that the magnitude of the effect on CFA with liprotamase did not appear to be as good as with porcine products, although they acknowledged that there was an unmet need for an alternative to those products, particularly for children and adolescents.

All but one of the panel members recommended that more studies on the efficacy of the liprotamase should be conducted before approval, including studies that directly compared it with porcine products and measured effects of treatment on height, weight, and body mass index over time, as well as the effect on symptoms such as flatulence, steatorrhea, and stool frequency, and on quality of life measures.

The panel was not asked specifically vote on whether to recommend approval.

The FDA usually follows the recommendations of its advisory panels. Panel members have been cleared of potential conflicts of interest by the FDA prior to the meeting. Occasionally, the FDA grants a waiver to a panelist with a conflict, but not at this meeting.

SILVER SPRING, Md. – A federal advisory panel on Jan. 12 voted 7 to 4, with 1 abstention, that the potential risks of liprotamase, a genetically engineered pancreatic enzyme formulation, outweighed its benefits as a treatment for exocrine pancreatic insufficiency.

Liprotamase – which contains lipase, protease, and amylase and is available in capsule form and in one strength only – is being reviewed by the Food and Drug Administration for the treatment for patients with exocrine pancreatic insufficiency (EPI) caused by cystic fibrosis (CF), chronic pancreatitis (CP), pancreatectomy, or other conditions that limit or impair function of the pancreas; this indication was proposed by the manufacturer, Alnara Pharmaceuticals. If approved, liprotamase would be the first nonporcine-derived pancreatic enzyme therapy available in the United States. Porcine-derived pancreatic enzyme products have been available for years; currently, three such products are approved.

At the meeting of FDA’s Gastrointestinal Drugs Advisory Committee, the majority of the panelists agreed that the data from the pivotal trial, which compared liprotamase (32,000 U) per meal to placebo in 138 patients with CF-related EPI over 6 weeks did not provide enough evidence for efficacy. The primary end point was changes from baseline in the coefficient of fat absorption (CFA), a measure of the amount of dietary fat absorbed that has been accepted as a surrogate end point for the porcine-derived products, because an increase in fat absorption has been associated with improvements in clinical outcomes.

In the study, the CFA increased by 11% among those on treatment, compared with 0.2% among those on placebo. The panel voted 10 to 1, with 1 abstention, that the magnitude of the change in CFA among those on liprotamase was not sufficient to be clinically meaningful. Panelists also observed that the magnitude of the effect on CFA with liprotamase did not appear to be as good as with porcine products, although they acknowledged that there was an unmet need for an alternative to those products, particularly for children and adolescents.

All but one of the panel members recommended that more studies on the efficacy of the liprotamase should be conducted before approval, including studies that directly compared it with porcine products and measured effects of treatment on height, weight, and body mass index over time, as well as the effect on symptoms such as flatulence, steatorrhea, and stool frequency, and on quality of life measures.

The panel was not asked specifically vote on whether to recommend approval.

The FDA usually follows the recommendations of its advisory panels. Panel members have been cleared of potential conflicts of interest by the FDA prior to the meeting. Occasionally, the FDA grants a waiver to a panelist with a conflict, but not at this meeting.

SILVER SPRING, Md. – A federal advisory panel on Jan. 12 voted 7 to 4, with 1 abstention, that the potential risks of liprotamase, a genetically engineered pancreatic enzyme formulation, outweighed its benefits as a treatment for exocrine pancreatic insufficiency.

Liprotamase – which contains lipase, protease, and amylase and is available in capsule form and in one strength only – is being reviewed by the Food and Drug Administration for the treatment for patients with exocrine pancreatic insufficiency (EPI) caused by cystic fibrosis (CF), chronic pancreatitis (CP), pancreatectomy, or other conditions that limit or impair function of the pancreas; this indication was proposed by the manufacturer, Alnara Pharmaceuticals. If approved, liprotamase would be the first nonporcine-derived pancreatic enzyme therapy available in the United States. Porcine-derived pancreatic enzyme products have been available for years; currently, three such products are approved.

At the meeting of FDA’s Gastrointestinal Drugs Advisory Committee, the majority of the panelists agreed that the data from the pivotal trial, which compared liprotamase (32,000 U) per meal to placebo in 138 patients with CF-related EPI over 6 weeks did not provide enough evidence for efficacy. The primary end point was changes from baseline in the coefficient of fat absorption (CFA), a measure of the amount of dietary fat absorbed that has been accepted as a surrogate end point for the porcine-derived products, because an increase in fat absorption has been associated with improvements in clinical outcomes.

In the study, the CFA increased by 11% among those on treatment, compared with 0.2% among those on placebo. The panel voted 10 to 1, with 1 abstention, that the magnitude of the change in CFA among those on liprotamase was not sufficient to be clinically meaningful. Panelists also observed that the magnitude of the effect on CFA with liprotamase did not appear to be as good as with porcine products, although they acknowledged that there was an unmet need for an alternative to those products, particularly for children and adolescents.

All but one of the panel members recommended that more studies on the efficacy of the liprotamase should be conducted before approval, including studies that directly compared it with porcine products and measured effects of treatment on height, weight, and body mass index over time, as well as the effect on symptoms such as flatulence, steatorrhea, and stool frequency, and on quality of life measures.

The panel was not asked specifically vote on whether to recommend approval.

The FDA usually follows the recommendations of its advisory panels. Panel members have been cleared of potential conflicts of interest by the FDA prior to the meeting. Occasionally, the FDA grants a waiver to a panelist with a conflict, but not at this meeting.

SILVER SPRING, Md. – A federal advisory panel on Jan. 12 voted 7 to 4, with 1 abstention, that the potential risks of liprotamase, a genetically engineered pancreatic enzyme formulation, outweighed its benefits as a treatment for exocrine pancreatic insufficiency.

Liprotamase – which contains lipase, protease, and amylase and is available in capsule form and in one strength only – is being reviewed by the Food and Drug Administration for the treatment for patients with exocrine pancreatic insufficiency (EPI) caused by cystic fibrosis (CF), chronic pancreatitis (CP), pancreatectomy, or other conditions that limit or impair function of the pancreas; this indication was proposed by the manufacturer, Alnara Pharmaceuticals. If approved, liprotamase would be the first nonporcine-derived pancreatic enzyme therapy available in the United States. Porcine-derived pancreatic enzyme products have been available for years; currently, three such products are approved.

At the meeting of FDA’s Gastrointestinal Drugs Advisory Committee, the majority of the panelists agreed that the data from the pivotal trial, which compared liprotamase (32,000 U) per meal to placebo in 138 patients with CF-related EPI over 6 weeks did not provide enough evidence for efficacy. The primary end point was changes from baseline in the coefficient of fat absorption (CFA), a measure of the amount of dietary fat absorbed that has been accepted as a surrogate end point for the porcine-derived products, because an increase in fat absorption has been associated with improvements in clinical outcomes.

In the study, the CFA increased by 11% among those on treatment, compared with 0.2% among those on placebo. The panel voted 10 to 1, with 1 abstention, that the magnitude of the change in CFA among those on liprotamase was not sufficient to be clinically meaningful. Panelists also observed that the magnitude of the effect on CFA with liprotamase did not appear to be as good as with porcine products, although they acknowledged that there was an unmet need for an alternative to those products, particularly for children and adolescents.

All but one of the panel members recommended that more studies on the efficacy of the liprotamase should be conducted before approval, including studies that directly compared it with porcine products and measured effects of treatment on height, weight, and body mass index over time, as well as the effect on symptoms such as flatulence, steatorrhea, and stool frequency, and on quality of life measures.

The panel was not asked specifically vote on whether to recommend approval.

The FDA usually follows the recommendations of its advisory panels. Panel members have been cleared of potential conflicts of interest by the FDA prior to the meeting. Occasionally, the FDA grants a waiver to a panelist with a conflict, but not at this meeting.

SILVER SPRING, Md. – A federal advisory panel on Jan. 12 voted 7 to 4, with 1 abstention, that the potential risks of liprotamase, a genetically engineered pancreatic enzyme formulation, outweighed its benefits as a treatment for exocrine pancreatic insufficiency.

Liprotamase – which contains lipase, protease, and amylase and is available in capsule form and in one strength only – is being reviewed by the Food and Drug Administration for the treatment for patients with exocrine pancreatic insufficiency (EPI) caused by cystic fibrosis (CF), chronic pancreatitis (CP), pancreatectomy, or other conditions that limit or impair function of the pancreas; this indication was proposed by the manufacturer, Alnara Pharmaceuticals. If approved, liprotamase would be the first nonporcine-derived pancreatic enzyme therapy available in the United States. Porcine-derived pancreatic enzyme products have been available for years; currently, three such products are approved.

At the meeting of FDA’s Gastrointestinal Drugs Advisory Committee, the majority of the panelists agreed that the data from the pivotal trial, which compared liprotamase (32,000 U) per meal to placebo in 138 patients with CF-related EPI over 6 weeks did not provide enough evidence for efficacy. The primary end point was changes from baseline in the coefficient of fat absorption (CFA), a measure of the amount of dietary fat absorbed that has been accepted as a surrogate end point for the porcine-derived products, because an increase in fat absorption has been associated with improvements in clinical outcomes.

In the study, the CFA increased by 11% among those on treatment, compared with 0.2% among those on placebo. The panel voted 10 to 1, with 1 abstention, that the magnitude of the change in CFA among those on liprotamase was not sufficient to be clinically meaningful. Panelists also observed that the magnitude of the effect on CFA with liprotamase did not appear to be as good as with porcine products, although they acknowledged that there was an unmet need for an alternative to those products, particularly for children and adolescents.

All but one of the panel members recommended that more studies on the efficacy of the liprotamase should be conducted before approval, including studies that directly compared it with porcine products and measured effects of treatment on height, weight, and body mass index over time, as well as the effect on symptoms such as flatulence, steatorrhea, and stool frequency, and on quality of life measures.

The panel was not asked specifically vote on whether to recommend approval.

The FDA usually follows the recommendations of its advisory panels. Panel members have been cleared of potential conflicts of interest by the FDA prior to the meeting. Occasionally, the FDA grants a waiver to a panelist with a conflict, but not at this meeting.

SILVER SPRING, Md. – A federal advisory panel on Jan. 12 voted 7 to 4, with 1 abstention, that the potential risks of liprotamase, a genetically engineered pancreatic enzyme formulation, outweighed its benefits as a treatment for exocrine pancreatic insufficiency.

Liprotamase – which contains lipase, protease, and amylase and is available in capsule form and in one strength only – is being reviewed by the Food and Drug Administration for the treatment for patients with exocrine pancreatic insufficiency (EPI) caused by cystic fibrosis (CF), chronic pancreatitis (CP), pancreatectomy, or other conditions that limit or impair function of the pancreas; this indication was proposed by the manufacturer, Alnara Pharmaceuticals. If approved, liprotamase would be the first nonporcine-derived pancreatic enzyme therapy available in the United States. Porcine-derived pancreatic enzyme products have been available for years; currently, three such products are approved.

At the meeting of FDA’s Gastrointestinal Drugs Advisory Committee, the majority of the panelists agreed that the data from the pivotal trial, which compared liprotamase (32,000 U) per meal to placebo in 138 patients with CF-related EPI over 6 weeks did not provide enough evidence for efficacy. The primary end point was changes from baseline in the coefficient of fat absorption (CFA), a measure of the amount of dietary fat absorbed that has been accepted as a surrogate end point for the porcine-derived products, because an increase in fat absorption has been associated with improvements in clinical outcomes.

In the study, the CFA increased by 11% among those on treatment, compared with 0.2% among those on placebo. The panel voted 10 to 1, with 1 abstention, that the magnitude of the change in CFA among those on liprotamase was not sufficient to be clinically meaningful. Panelists also observed that the magnitude of the effect on CFA with liprotamase did not appear to be as good as with porcine products, although they acknowledged that there was an unmet need for an alternative to those products, particularly for children and adolescents.

All but one of the panel members recommended that more studies on the efficacy of the liprotamase should be conducted before approval, including studies that directly compared it with porcine products and measured effects of treatment on height, weight, and body mass index over time, as well as the effect on symptoms such as flatulence, steatorrhea, and stool frequency, and on quality of life measures.

The panel was not asked specifically vote on whether to recommend approval.

The FDA usually follows the recommendations of its advisory panels. Panel members have been cleared of potential conflicts of interest by the FDA prior to the meeting. Occasionally, the FDA grants a waiver to a panelist with a conflict, but not at this meeting.

Dr. Joshua Sharfstein, the Food and Drug Administration's principal deputy commissioner, is leaving the agency to become Maryland's health secretary.

Maryland Gov. Martin O'Malley announced the appointment of Dr. Sharfstein as the state's secretary of health and mental hygiene on Jan. 5. Dr. Sharfstein, a pediatrician, will start his new position on Jan. 12, to coincide with the beginning of the state's new legislative session.

Dr. Sharfstein was appointed to the FDA position in May 2009 by President Obama after having served as the acting commissioner for food and drugs for several months. Previously, he had served as the Baltimore city health commissioner, during which time he questioned the safety of over-the-counter cough and cold products in young children. His efforts received national attention and resulted in FDA hearings on the topic and, ultimately, product restrictions.

During his nearly 2 years at the FDA, Dr. Sharfstein gained a reputation as a tough, intelligent regulator who, alongside Commissioner Margaret Hamburg, sought to restore the FDA's role as an agency whose foremost mission is to protect and promote public health. Their initiatives included expediting responses to product safety issues and manufacturer violations. Additionally during his tenure, the agency re-examined its controversial decision to clear a knee repair device, leading to a current re-evaluation of the how the FDA reviews medical devices.

Dr. Sharfstein also led an agency task force charged with making FDA information on regulated products more widely available to improve the public's understanding of agency decisions.

John Taylor, counselor to the commissioner, has been asked to serve as the acting principal deputy commissioner for the next 60 days, the FDA said in a written statement.

Jessica Bylander of "The Gray Sheet," also published by Elsevier, contributed to this report.

Dr. Joshua Sharfstein, the Food and Drug Administration's principal deputy commissioner, is leaving the agency to become Maryland's health secretary.

Maryland Gov. Martin O'Malley announced the appointment of Dr. Sharfstein as the state's secretary of health and mental hygiene on Jan. 5. Dr. Sharfstein, a pediatrician, will start his new position on Jan. 12, to coincide with the beginning of the state's new legislative session.

Dr. Sharfstein was appointed to the FDA position in May 2009 by President Obama after having served as the acting commissioner for food and drugs for several months. Previously, he had served as the Baltimore city health commissioner, during which time he questioned the safety of over-the-counter cough and cold products in young children. His efforts received national attention and resulted in FDA hearings on the topic and, ultimately, product restrictions.

During his nearly 2 years at the FDA, Dr. Sharfstein gained a reputation as a tough, intelligent regulator who, alongside Commissioner Margaret Hamburg, sought to restore the FDA's role as an agency whose foremost mission is to protect and promote public health. Their initiatives included expediting responses to product safety issues and manufacturer violations. Additionally during his tenure, the agency re-examined its controversial decision to clear a knee repair device, leading to a current re-evaluation of the how the FDA reviews medical devices.

Dr. Sharfstein also led an agency task force charged with making FDA information on regulated products more widely available to improve the public's understanding of agency decisions.

John Taylor, counselor to the commissioner, has been asked to serve as the acting principal deputy commissioner for the next 60 days, the FDA said in a written statement.

Jessica Bylander of "The Gray Sheet," also published by Elsevier, contributed to this report.

Dr. Joshua Sharfstein, the Food and Drug Administration's principal deputy commissioner, is leaving the agency to become Maryland's health secretary.

Maryland Gov. Martin O'Malley announced the appointment of Dr. Sharfstein as the state's secretary of health and mental hygiene on Jan. 5. Dr. Sharfstein, a pediatrician, will start his new position on Jan. 12, to coincide with the beginning of the state's new legislative session.

Dr. Sharfstein was appointed to the FDA position in May 2009 by President Obama after having served as the acting commissioner for food and drugs for several months. Previously, he had served as the Baltimore city health commissioner, during which time he questioned the safety of over-the-counter cough and cold products in young children. His efforts received national attention and resulted in FDA hearings on the topic and, ultimately, product restrictions.

During his nearly 2 years at the FDA, Dr. Sharfstein gained a reputation as a tough, intelligent regulator who, alongside Commissioner Margaret Hamburg, sought to restore the FDA's role as an agency whose foremost mission is to protect and promote public health. Their initiatives included expediting responses to product safety issues and manufacturer violations. Additionally during his tenure, the agency re-examined its controversial decision to clear a knee repair device, leading to a current re-evaluation of the how the FDA reviews medical devices.

Dr. Sharfstein also led an agency task force charged with making FDA information on regulated products more widely available to improve the public's understanding of agency decisions.

John Taylor, counselor to the commissioner, has been asked to serve as the acting principal deputy commissioner for the next 60 days, the FDA said in a written statement.

Jessica Bylander of "The Gray Sheet," also published by Elsevier, contributed to this report.

Dr. Joshua Sharfstein, the Food and Drug Administration’s principal deputy commissioner, is leaving the agency to become Maryland’s health secretary.

Maryland Gov. Martin O’Malley announced the appointment of Dr. Sharfstein as the state’s secretary of health and mental hygiene on Jan. 5. Dr. Sharfstein, a pediatrician, will start his new position on Jan. 12, to coincide with the beginning of the state’s new legislative session.

Dr. Sharfstein was appointed to the FDA position in May 2009 by President Obama after having served as the acting commissioner for food and drugs for several months. Previously, he had served as the Baltimore city health commissioner, during which time he questioned the safety of over-the-counter cough and cold products in young children. His efforts received national attention and resulted in FDA hearings on the topic and, ultimately, product restrictions.

During his nearly 2 years at the FDA, Dr. Sharfstein gained a reputation as a tough, intelligent regulator who, alongside Commissioner Margaret Hamburg, sought to restore the FDA’s role as an agency whose foremost mission is to protect and promote public health. Their initiatives included expediting responses to product safety issues and manufacturer violations. Additionally during his tenure, the agency re-examined its controversial decision to clear a knee repair device, leading to a current re-evaluation of the how the FDA reviews medical devices.

Dr. Sharfstein also led an agency task force charged with making FDA information on regulated products more widely available to improve the public’s understanding of agency decisions.

John Taylor, counselor to the commissioner, has been asked to serve as the acting principal deputy commissioner for the next 60 days, the FDA said in a written statement.

Jessica Bylander of "The Gray Sheet," also published by Elsevier, contributed to this report.

Dr. Joshua Sharfstein, the Food and Drug Administration’s principal deputy commissioner, is leaving the agency to become Maryland’s health secretary.

Maryland Gov. Martin O’Malley announced the appointment of Dr. Sharfstein as the state’s secretary of health and mental hygiene on Jan. 5. Dr. Sharfstein, a pediatrician, will start his new position on Jan. 12, to coincide with the beginning of the state’s new legislative session.

Dr. Sharfstein was appointed to the FDA position in May 2009 by President Obama after having served as the acting commissioner for food and drugs for several months. Previously, he had served as the Baltimore city health commissioner, during which time he questioned the safety of over-the-counter cough and cold products in young children. His efforts received national attention and resulted in FDA hearings on the topic and, ultimately, product restrictions.

During his nearly 2 years at the FDA, Dr. Sharfstein gained a reputation as a tough, intelligent regulator who, alongside Commissioner Margaret Hamburg, sought to restore the FDA’s role as an agency whose foremost mission is to protect and promote public health. Their initiatives included expediting responses to product safety issues and manufacturer violations. Additionally during his tenure, the agency re-examined its controversial decision to clear a knee repair device, leading to a current re-evaluation of the how the FDA reviews medical devices.

Dr. Sharfstein also led an agency task force charged with making FDA information on regulated products more widely available to improve the public’s understanding of agency decisions.

John Taylor, counselor to the commissioner, has been asked to serve as the acting principal deputy commissioner for the next 60 days, the FDA said in a written statement.

Jessica Bylander of "The Gray Sheet," also published by Elsevier, contributed to this report.

Dr. Joshua Sharfstein, the Food and Drug Administration’s principal deputy commissioner, is leaving the agency to become Maryland’s health secretary.

Maryland Gov. Martin O’Malley announced the appointment of Dr. Sharfstein as the state’s secretary of health and mental hygiene on Jan. 5. Dr. Sharfstein, a pediatrician, will start his new position on Jan. 12, to coincide with the beginning of the state’s new legislative session.

Dr. Sharfstein was appointed to the FDA position in May 2009 by President Obama after having served as the acting commissioner for food and drugs for several months. Previously, he had served as the Baltimore city health commissioner, during which time he questioned the safety of over-the-counter cough and cold products in young children. His efforts received national attention and resulted in FDA hearings on the topic and, ultimately, product restrictions.

During his nearly 2 years at the FDA, Dr. Sharfstein gained a reputation as a tough, intelligent regulator who, alongside Commissioner Margaret Hamburg, sought to restore the FDA’s role as an agency whose foremost mission is to protect and promote public health. Their initiatives included expediting responses to product safety issues and manufacturer violations. Additionally during his tenure, the agency re-examined its controversial decision to clear a knee repair device, leading to a current re-evaluation of the how the FDA reviews medical devices.

Dr. Sharfstein also led an agency task force charged with making FDA information on regulated products more widely available to improve the public’s understanding of agency decisions.

John Taylor, counselor to the commissioner, has been asked to serve as the acting principal deputy commissioner for the next 60 days, the FDA said in a written statement.

Jessica Bylander of "The Gray Sheet," also published by Elsevier, contributed to this report.

Dr. Joshua Sharfstein, the Food and Drug Administration’s principal deputy commissioner, is leaving the agency to become Maryland’s health secretary.

Maryland Gov. Martin O’Malley announced the appointment of Dr. Sharfstein as the state’s secretary of health and mental hygiene on Jan. 5. Dr. Sharfstein, a pediatrician, will start his new position on Jan. 12, to coincide with the beginning of the state’s new legislative session.

Dr. Sharfstein was appointed to the FDA position in May 2009 by President Obama after having served as the acting commissioner for food and drugs for several months. Previously, he had served as the Baltimore city health commissioner, during which time he questioned the safety of over-the-counter cough and cold products in young children. His efforts received national attention and resulted in FDA hearings on the topic and, ultimately, product restrictions.

During his nearly 2 years at the FDA, Dr. Sharfstein gained a reputation as a tough, intelligent regulator who, alongside Commissioner Margaret Hamburg, sought to restore the FDA’s role as an agency whose foremost mission is to protect and promote public health. Their initiatives included expediting responses to product safety issues and manufacturer violations. Additionally during his tenure, the agency re-examined its controversial decision to clear a knee repair device, leading to a current re-evaluation of the how the FDA reviews medical devices.

Dr. Sharfstein also led an agency task force charged with making FDA information on regulated products more widely available to improve the public’s understanding of agency decisions.

John Taylor, counselor to the commissioner, has been asked to serve as the acting principal deputy commissioner for the next 60 days, the FDA said in a written statement.

Jessica Bylander of "The Gray Sheet," also published by Elsevier, contributed to this report.

Dr. Joshua Sharfstein, the Food and Drug Administration’s principal deputy commissioner, is leaving the agency to become Maryland’s health secretary.

Maryland Gov. Martin O’Malley announced the appointment of Dr. Sharfstein as the state’s secretary of health and mental hygiene on Jan. 5. Dr. Sharfstein, a pediatrician, will start his new position on Jan. 12, to coincide with the beginning of the state’s new legislative session.

Dr. Sharfstein was appointed to the FDA position in May 2009 by President Obama after having served as the acting commissioner for food and drugs for several months. Previously, he had served as the Baltimore city health commissioner, during which time he questioned the safety of over-the-counter cough and cold products in young children. His efforts received national attention and resulted in FDA hearings on the topic and, ultimately, product restrictions.

During his nearly 2 years at the FDA, Dr. Sharfstein gained a reputation as a tough, intelligent regulator who, alongside Commissioner Margaret Hamburg, sought to restore the FDA’s role as an agency whose foremost mission is to protect and promote public health. Their initiatives included expediting responses to product safety issues and manufacturer violations. Additionally during his tenure, the agency re-examined its controversial decision to clear a knee repair device, leading to a current re-evaluation of the how the FDA reviews medical devices.

Dr. Sharfstein also led an agency task force charged with making FDA information on regulated products more widely available to improve the public’s understanding of agency decisions.

John Taylor, counselor to the commissioner, has been asked to serve as the acting principal deputy commissioner for the next 60 days, the FDA said in a written statement.

Jessica Bylander of "The Gray Sheet," also published by Elsevier, contributed to this report.

Dr. Joshua Sharfstein, the Food and Drug Administration’s principal deputy commissioner, is leaving the agency to become Maryland’s health secretary.

Maryland Gov. Martin O’Malley announced the appointment of Dr. Sharfstein as the state’s secretary of health and mental hygiene on Jan. 5. Dr. Sharfstein, a pediatrician, will start his new position on Jan. 12, to coincide with the beginning of the state’s new legislative session.

Dr. Sharfstein was appointed to the FDA position in May 2009 by President Obama after having served as the acting commissioner for food and drugs for several months. Previously, he had served as the Baltimore city health commissioner, during which time he questioned the safety of over-the-counter cough and cold products in young children. His efforts received national attention and resulted in FDA hearings on the topic and, ultimately, product restrictions.

During his nearly 2 years at the FDA, Dr. Sharfstein gained a reputation as a tough, intelligent regulator who, alongside Commissioner Margaret Hamburg, sought to restore the FDA’s role as an agency whose foremost mission is to protect and promote public health. Their initiatives included expediting responses to product safety issues and manufacturer violations. Additionally during his tenure, the agency re-examined its controversial decision to clear a knee repair device, leading to a current re-evaluation of the how the FDA reviews medical devices.

Dr. Sharfstein also led an agency task force charged with making FDA information on regulated products more widely available to improve the public’s understanding of agency decisions.

John Taylor, counselor to the commissioner, has been asked to serve as the acting principal deputy commissioner for the next 60 days, the FDA said in a written statement.

Jessica Bylander of "The Gray Sheet," also published by Elsevier, contributed to this report.

The Infectious Diseases Society of America rolled out its first-ever guidelines for treating methicillin-resistant Staphylococcus aureus – including recommendations to battle the growing threat posed by MRSA-related skin and soft-tissue infections.

The comprehensive guidelines also outline evidence-based approaches on topics ranging from personal hygiene and wound care to antibiotic therapies for invasive MRSA, as well as options after vancomycin treatment failure.

The guidelines’ primary objective is "to provide recommendations on the management of some of the most common clinical syndromes encountered by adult and pediatric clinicians who care for patients with MRSA infections," according to the executive summary, published online Jan. 5 (Clin. Infect. Dis. 2010 [doi:10.1093/cid/ciq146]).

The guidelines provide adult and pediatric clinicians with guidance on how to treat relatively uncomplicated MRSA infections, as well as more serious infections, according to Dr. Catherine Liu, the guidelines’ lead author and assistant clinical professor in the division of infectious diseases, University of California, San Francisco. The recommendations cover community- and hospital-associated MRSA infections, she added.

MRSA infections account for about 60% of skin infections seen in U.S. emergency departments, and invasive MRSA infections cause about 18,000 deaths a year, according to the Infectious Diseases Society of America (IDSA).

The evidence-based guidelines, which will be published in the Feb. 1 issue of Clinical Infectious Diseases, have been endorsed by the Pediatric Infectious Diseases Society, the American College of Emergency Physicians, and the American Academy of Pediatrics.

The guidelines are voluntary and "are not intended to take the place of a doctor’s judgment, but rather support the decision-making process, which must be individualized according to each patient’s circumstances," according to a statement issued by IDSA, which funded the guidelines.

A 13-member expert panel reviewed hundreds of scientific studies, papers, and presentations to create the recommendations. The guidelines’ sections start with a clinical question, followed by a numbered list of recommendations and a summary of the most relevant evidence to support the recommendations. In most cases, the sections include information on pediatric considerations. The guidelines also highlight areas that are controversial because of limited or conflicting data.

The first topic addressed is the management of skin and soft tissue infections due to MRSA, which have become a significant problem in the past few years, Dr. Liu said in an interview. For example, MRSA is now the predominant organism causing skin infections in patients who present to emergency departments with skin infections, she noted.

The guidelines cover multiple types of skin infections, including abscesses, cellulitis, and more complicated skin infections. The guidelines also offer recommendations on the role of antibiotics, including whether or not they need to be used, situations in which they may not be indicated, and when they definitely should be used. They also offer guidance "on specific types of antibiotic choices that clinicians should consider," Dr. Liu noted.

Other topics covered include the management of MRSA pneumonia, bacteremia, and infective endocarditis; central nervous system infections; and bone and joint infections. Additional sections review the role of adjunctive therapies in the treatment of MRSA infections, MRSA infections in neonates, and specific recommendations on vancomycin dosing and monitoring.

IDSA will update the guidelines as more information and newer antibiotics become available. However, timely updating can be difficult because of the review and publication process, Dr. Liu noted.

For example, the Food and Drug Administration approved the intravenous cephalosporin antibiotic ceftaroline in October 2010 for acute bacterial skin and soft tissue infections, including cases caused by MRSA. But approval came after the IDSA guidelines were finalized, and that information was not included. Nonetheless, the guidelines note that ceftaroline "may become available in the near future for the treatment" of complicated skin and skin structure infections, Dr. Liu said.

The guidelines do not address active surveillance testing or other strategies aimed at preventing MRSA in health care settings, topics that have been addressed in previously released guidelines.

IDSA funded the development of the guidelines. Of the expert panel’s 13 members, 9 reported having potential conflicts of interest that included honoraria or research support from, or having served as a consultant or adviser to, pharmaceutical companies, including Astellas, Cubist Pharmaceutical, Forest, Merck, Ortho-McNeil, Pfizer, Sanofi-Aventis, Schering-Plough, and Theravance. The remaining authors of the guidelines, including the lead author, Dr. Catherine Liu, reported no conflicts.

The Infectious Diseases Society of America rolled out its first-ever guidelines for treating methicillin-resistant Staphylococcus aureus – including recommendations to battle the growing threat posed by MRSA-related skin and soft-tissue infections.

The comprehensive guidelines also outline evidence-based approaches on topics ranging from personal hygiene and wound care to antibiotic therapies for invasive MRSA, as well as options after vancomycin treatment failure.

The guidelines’ primary objective is "to provide recommendations on the management of some of the most common clinical syndromes encountered by adult and pediatric clinicians who care for patients with MRSA infections," according to the executive summary, published online Jan. 5 (Clin. Infect. Dis. 2010 [doi:10.1093/cid/ciq146]).

The guidelines provide adult and pediatric clinicians with guidance on how to treat relatively uncomplicated MRSA infections, as well as more serious infections, according to Dr. Catherine Liu, the guidelines’ lead author and assistant clinical professor in the division of infectious diseases, University of California, San Francisco. The recommendations cover community- and hospital-associated MRSA infections, she added.

MRSA infections account for about 60% of skin infections seen in U.S. emergency departments, and invasive MRSA infections cause about 18,000 deaths a year, according to the Infectious Diseases Society of America (IDSA).

The evidence-based guidelines, which will be published in the Feb. 1 issue of Clinical Infectious Diseases, have been endorsed by the Pediatric Infectious Diseases Society, the American College of Emergency Physicians, and the American Academy of Pediatrics.

The guidelines are voluntary and "are not intended to take the place of a doctor’s judgment, but rather support the decision-making process, which must be individualized according to each patient’s circumstances," according to a statement issued by IDSA, which funded the guidelines.

A 13-member expert panel reviewed hundreds of scientific studies, papers, and presentations to create the recommendations. The guidelines’ sections start with a clinical question, followed by a numbered list of recommendations and a summary of the most relevant evidence to support the recommendations. In most cases, the sections include information on pediatric considerations. The guidelines also highlight areas that are controversial because of limited or conflicting data.

The first topic addressed is the management of skin and soft tissue infections due to MRSA, which have become a significant problem in the past few years, Dr. Liu said in an interview. For example, MRSA is now the predominant organism causing skin infections in patients who present to emergency departments with skin infections, she noted.

The guidelines cover multiple types of skin infections, including abscesses, cellulitis, and more complicated skin infections. The guidelines also offer recommendations on the role of antibiotics, including whether or not they need to be used, situations in which they may not be indicated, and when they definitely should be used. They also offer guidance "on specific types of antibiotic choices that clinicians should consider," Dr. Liu noted.

Other topics covered include the management of MRSA pneumonia, bacteremia, and infective endocarditis; central nervous system infections; and bone and joint infections. Additional sections review the role of adjunctive therapies in the treatment of MRSA infections, MRSA infections in neonates, and specific recommendations on vancomycin dosing and monitoring.

IDSA will update the guidelines as more information and newer antibiotics become available. However, timely updating can be difficult because of the review and publication process, Dr. Liu noted.

For example, the Food and Drug Administration approved the intravenous cephalosporin antibiotic ceftaroline in October 2010 for acute bacterial skin and soft tissue infections, including cases caused by MRSA. But approval came after the IDSA guidelines were finalized, and that information was not included. Nonetheless, the guidelines note that ceftaroline "may become available in the near future for the treatment" of complicated skin and skin structure infections, Dr. Liu said.

The guidelines do not address active surveillance testing or other strategies aimed at preventing MRSA in health care settings, topics that have been addressed in previously released guidelines.

IDSA funded the development of the guidelines. Of the expert panel’s 13 members, 9 reported having potential conflicts of interest that included honoraria or research support from, or having served as a consultant or adviser to, pharmaceutical companies, including Astellas, Cubist Pharmaceutical, Forest, Merck, Ortho-McNeil, Pfizer, Sanofi-Aventis, Schering-Plough, and Theravance. The remaining authors of the guidelines, including the lead author, Dr. Catherine Liu, reported no conflicts.

The Infectious Diseases Society of America rolled out its first-ever guidelines for treating methicillin-resistant Staphylococcus aureus – including recommendations to battle the growing threat posed by MRSA-related skin and soft-tissue infections.

The comprehensive guidelines also outline evidence-based approaches on topics ranging from personal hygiene and wound care to antibiotic therapies for invasive MRSA, as well as options after vancomycin treatment failure.

The guidelines’ primary objective is "to provide recommendations on the management of some of the most common clinical syndromes encountered by adult and pediatric clinicians who care for patients with MRSA infections," according to the executive summary, published online Jan. 5 (Clin. Infect. Dis. 2010 [doi:10.1093/cid/ciq146]).

The guidelines provide adult and pediatric clinicians with guidance on how to treat relatively uncomplicated MRSA infections, as well as more serious infections, according to Dr. Catherine Liu, the guidelines’ lead author and assistant clinical professor in the division of infectious diseases, University of California, San Francisco. The recommendations cover community- and hospital-associated MRSA infections, she added.

MRSA infections account for about 60% of skin infections seen in U.S. emergency departments, and invasive MRSA infections cause about 18,000 deaths a year, according to the Infectious Diseases Society of America (IDSA).

The evidence-based guidelines, which will be published in the Feb. 1 issue of Clinical Infectious Diseases, have been endorsed by the Pediatric Infectious Diseases Society, the American College of Emergency Physicians, and the American Academy of Pediatrics.

The guidelines are voluntary and "are not intended to take the place of a doctor’s judgment, but rather support the decision-making process, which must be individualized according to each patient’s circumstances," according to a statement issued by IDSA, which funded the guidelines.

A 13-member expert panel reviewed hundreds of scientific studies, papers, and presentations to create the recommendations. The guidelines’ sections start with a clinical question, followed by a numbered list of recommendations and a summary of the most relevant evidence to support the recommendations. In most cases, the sections include information on pediatric considerations. The guidelines also highlight areas that are controversial because of limited or conflicting data.

The first topic addressed is the management of skin and soft tissue infections due to MRSA, which have become a significant problem in the past few years, Dr. Liu said in an interview. For example, MRSA is now the predominant organism causing skin infections in patients who present to emergency departments with skin infections, she noted.

The guidelines cover multiple types of skin infections, including abscesses, cellulitis, and more complicated skin infections. The guidelines also offer recommendations on the role of antibiotics, including whether or not they need to be used, situations in which they may not be indicated, and when they definitely should be used. They also offer guidance "on specific types of antibiotic choices that clinicians should consider," Dr. Liu noted.

Other topics covered include the management of MRSA pneumonia, bacteremia, and infective endocarditis; central nervous system infections; and bone and joint infections. Additional sections review the role of adjunctive therapies in the treatment of MRSA infections, MRSA infections in neonates, and specific recommendations on vancomycin dosing and monitoring.

IDSA will update the guidelines as more information and newer antibiotics become available. However, timely updating can be difficult because of the review and publication process, Dr. Liu noted.

For example, the Food and Drug Administration approved the intravenous cephalosporin antibiotic ceftaroline in October 2010 for acute bacterial skin and soft tissue infections, including cases caused by MRSA. But approval came after the IDSA guidelines were finalized, and that information was not included. Nonetheless, the guidelines note that ceftaroline "may become available in the near future for the treatment" of complicated skin and skin structure infections, Dr. Liu said.

The guidelines do not address active surveillance testing or other strategies aimed at preventing MRSA in health care settings, topics that have been addressed in previously released guidelines.

IDSA funded the development of the guidelines. Of the expert panel’s 13 members, 9 reported having potential conflicts of interest that included honoraria or research support from, or having served as a consultant or adviser to, pharmaceutical companies, including Astellas, Cubist Pharmaceutical, Forest, Merck, Ortho-McNeil, Pfizer, Sanofi-Aventis, Schering-Plough, and Theravance. The remaining authors of the guidelines, including the lead author, Dr. Catherine Liu, reported no conflicts.

The Infectious Diseases Society of America rolled out its first-ever guidelines for treating methicillin-resistant Staphylococcus aureus – including recommendations to battle the growing threat posed by MRSA-related skin and soft-tissue infections.

The comprehensive guidelines also outline evidence-based approaches on topics ranging from personal hygiene and wound care to antibiotic therapies for invasive MRSA, as well as options after vancomycin treatment failure.

The guidelines' primary objective is "to provide recommendations on the management of some of the most common clinical syndromes encountered by adult and pediatric clinicians who care for patients with MRSA infections," according to the executive summary, published online Jan. 5 (Clin. Infect. Dis. 2010 [doi:10.1093/cid/ciq146]).

The guidelines provide adult and pediatric clinicians with guidance on how to treat relatively uncomplicated MRSA infections, as well as more serious infections, according to Dr. Catherine Liu, the guidelines' lead author and assistant clinical professor in the division of infectious diseases, University of California, San Francisco. The recommendations cover community- and hospital-associated MRSA infections, she added.

MRSA infections account for about 60% of skin infections seen in U.S. emergency departments, and invasive MRSA infections cause about 18,000 deaths a year, according to the Infectious Diseases Society of America (IDSA).

The evidence-based guidelines, which will be published in the Feb. 1 issue of Clinical Infectious Diseases, have been endorsed by the Pediatric Infectious Diseases Society, the American College of Emergency Physicians, and the American Academy of Pediatrics.

The guidelines are voluntary and "are not intended to take the place of a doctor's judgment, but rather support the decision-making process, which must be individualized according to each patient's circumstances," according to a statement issued by IDSA, which funded the guidelines.

A 13-member expert panel reviewed hundreds of scientific studies, papers, and presentations to create the recommendations. The guidelines' sections start with a clinical question, followed by a numbered list of recommendations and a summary of the most relevant evidence to support the recommendations. In most cases, the sections include information on pediatric considerations. The guidelines also highlight areas that are controversial because of limited or conflicting data.

The first topic addressed is the management of skin and soft tissue infections due to MRSA, which have become a significant problem in the past few years, Dr. Liu said in an interview. For example, MRSA is now the predominant organism causing skin infections in patients who present to emergency departments with skin infections, she noted.

The guidelines cover multiple types of skin infections, including abscesses, cellulitis, and more complicated skin infections. The guidelines also offer recommendations on the role of antibiotics, including whether or not they need to be used, situations in which they may not be indicated, and when they definitely should be used. They also offer guidance " on specific types of antibiotic choices that clinicians should consider," Dr. Liu noted.

Other topics covered include the management of MRSA pneumonia, bacteremia, and infective endocarditis; central nervous system infections; and bone and joint infections. Additional sections review the role of adjunctive therapies in the treatment of MRSA infections, MRSA infections in neonates, and specific recommendations on vancomycin dosing and monitoring.

IDSA will update the guidelines as more information and newer antibiotics become available. However, timely updating can be difficult because of the review and publication process, Dr. Liu noted.

For example, the Food and Drug Administration approved the intravenous cephalosporin antibiotic ceftaroline in October 2010 for acute bacterial skin and soft tissue infections, including cases caused by MRSA. But approval came after the IDSA guidelines were finalized, and that information was not included. Nonetheless, the guidelines note that ceftaroline "may become available in the near future for the treatment" of complicated skin and skin structure infections, Dr. Liu said.

The guidelines do not address active surveillance testing or other strategies aimed at preventing MRSA in health care settings, topics that have been addressed in previously released guidelines.

IDSA funded the development of the guidelines. Of the expert panel's 13 members, 9 reported having potential conflicts of interest that included honoraria or research support from, or having served as a consultant or adviser to, pharmaceutical companies, including Astellas, Cubist Pharmaceutical, Forest, Merck, Ortho-McNeil, Pfizer, Sanofi-Aventis, Schering-Plough, and Theravance. The remaining authors of the guidelines, including the lead author, Dr. Catherine Liu, reported no conflicts.

The Infectious Diseases Society of America rolled out its first-ever guidelines for treating methicillin-resistant Staphylococcus aureus – including recommendations to battle the growing threat posed by MRSA-related skin and soft-tissue infections.

The comprehensive guidelines also outline evidence-based approaches on topics ranging from personal hygiene and wound care to antibiotic therapies for invasive MRSA, as well as options after vancomycin treatment failure.

The guidelines' primary objective is "to provide recommendations on the management of some of the most common clinical syndromes encountered by adult and pediatric clinicians who care for patients with MRSA infections," according to the executive summary, published online Jan. 5 (Clin. Infect. Dis. 2010 [doi:10.1093/cid/ciq146]).

The guidelines provide adult and pediatric clinicians with guidance on how to treat relatively uncomplicated MRSA infections, as well as more serious infections, according to Dr. Catherine Liu, the guidelines' lead author and assistant clinical professor in the division of infectious diseases, University of California, San Francisco. The recommendations cover community- and hospital-associated MRSA infections, she added.

MRSA infections account for about 60% of skin infections seen in U.S. emergency departments, and invasive MRSA infections cause about 18,000 deaths a year, according to the Infectious Diseases Society of America (IDSA).

The evidence-based guidelines, which will be published in the Feb. 1 issue of Clinical Infectious Diseases, have been endorsed by the Pediatric Infectious Diseases Society, the American College of Emergency Physicians, and the American Academy of Pediatrics.

The guidelines are voluntary and "are not intended to take the place of a doctor's judgment, but rather support the decision-making process, which must be individualized according to each patient's circumstances," according to a statement issued by IDSA, which funded the guidelines.

A 13-member expert panel reviewed hundreds of scientific studies, papers, and presentations to create the recommendations. The guidelines' sections start with a clinical question, followed by a numbered list of recommendations and a summary of the most relevant evidence to support the recommendations. In most cases, the sections include information on pediatric considerations. The guidelines also highlight areas that are controversial because of limited or conflicting data.

The first topic addressed is the management of skin and soft tissue infections due to MRSA, which have become a significant problem in the past few years, Dr. Liu said in an interview. For example, MRSA is now the predominant organism causing skin infections in patients who present to emergency departments with skin infections, she noted.

The guidelines cover multiple types of skin infections, including abscesses, cellulitis, and more complicated skin infections. The guidelines also offer recommendations on the role of antibiotics, including whether or not they need to be used, situations in which they may not be indicated, and when they definitely should be used. They also offer guidance " on specific types of antibiotic choices that clinicians should consider," Dr. Liu noted.

Other topics covered include the management of MRSA pneumonia, bacteremia, and infective endocarditis; central nervous system infections; and bone and joint infections. Additional sections review the role of adjunctive therapies in the treatment of MRSA infections, MRSA infections in neonates, and specific recommendations on vancomycin dosing and monitoring.

IDSA will update the guidelines as more information and newer antibiotics become available. However, timely updating can be difficult because of the review and publication process, Dr. Liu noted.

For example, the Food and Drug Administration approved the intravenous cephalosporin antibiotic ceftaroline in October 2010 for acute bacterial skin and soft tissue infections, including cases caused by MRSA. But approval came after the IDSA guidelines were finalized, and that information was not included. Nonetheless, the guidelines note that ceftaroline "may become available in the near future for the treatment" of complicated skin and skin structure infections, Dr. Liu said.

The guidelines do not address active surveillance testing or other strategies aimed at preventing MRSA in health care settings, topics that have been addressed in previously released guidelines.

IDSA funded the development of the guidelines. Of the expert panel's 13 members, 9 reported having potential conflicts of interest that included honoraria or research support from, or having served as a consultant or adviser to, pharmaceutical companies, including Astellas, Cubist Pharmaceutical, Forest, Merck, Ortho-McNeil, Pfizer, Sanofi-Aventis, Schering-Plough, and Theravance. The remaining authors of the guidelines, including the lead author, Dr. Catherine Liu, reported no conflicts.

The Infectious Diseases Society of America rolled out its first-ever guidelines for treating methicillin-resistant Staphylococcus aureus – including recommendations to battle the growing threat posed by MRSA-related skin and soft-tissue infections.

The comprehensive guidelines also outline evidence-based approaches on topics ranging from personal hygiene and wound care to antibiotic therapies for invasive MRSA, as well as options after vancomycin treatment failure.

The guidelines' primary objective is "to provide recommendations on the management of some of the most common clinical syndromes encountered by adult and pediatric clinicians who care for patients with MRSA infections," according to the executive summary, published online Jan. 5 (Clin. Infect. Dis. 2010 [doi:10.1093/cid/ciq146]).

The guidelines provide adult and pediatric clinicians with guidance on how to treat relatively uncomplicated MRSA infections, as well as more serious infections, according to Dr. Catherine Liu, the guidelines' lead author and assistant clinical professor in the division of infectious diseases, University of California, San Francisco. The recommendations cover community- and hospital-associated MRSA infections, she added.

MRSA infections account for about 60% of skin infections seen in U.S. emergency departments, and invasive MRSA infections cause about 18,000 deaths a year, according to the Infectious Diseases Society of America (IDSA).

The evidence-based guidelines, which will be published in the Feb. 1 issue of Clinical Infectious Diseases, have been endorsed by the Pediatric Infectious Diseases Society, the American College of Emergency Physicians, and the American Academy of Pediatrics.

The guidelines are voluntary and "are not intended to take the place of a doctor's judgment, but rather support the decision-making process, which must be individualized according to each patient's circumstances," according to a statement issued by IDSA, which funded the guidelines.

A 13-member expert panel reviewed hundreds of scientific studies, papers, and presentations to create the recommendations. The guidelines' sections start with a clinical question, followed by a numbered list of recommendations and a summary of the most relevant evidence to support the recommendations. In most cases, the sections include information on pediatric considerations. The guidelines also highlight areas that are controversial because of limited or conflicting data.

The first topic addressed is the management of skin and soft tissue infections due to MRSA, which have become a significant problem in the past few years, Dr. Liu said in an interview. For example, MRSA is now the predominant organism causing skin infections in patients who present to emergency departments with skin infections, she noted.

The guidelines cover multiple types of skin infections, including abscesses, cellulitis, and more complicated skin infections. The guidelines also offer recommendations on the role of antibiotics, including whether or not they need to be used, situations in which they may not be indicated, and when they definitely should be used. They also offer guidance " on specific types of antibiotic choices that clinicians should consider," Dr. Liu noted.

Other topics covered include the management of MRSA pneumonia, bacteremia, and infective endocarditis; central nervous system infections; and bone and joint infections. Additional sections review the role of adjunctive therapies in the treatment of MRSA infections, MRSA infections in neonates, and specific recommendations on vancomycin dosing and monitoring.

IDSA will update the guidelines as more information and newer antibiotics become available. However, timely updating can be difficult because of the review and publication process, Dr. Liu noted.

For example, the Food and Drug Administration approved the intravenous cephalosporin antibiotic ceftaroline in October 2010 for acute bacterial skin and soft tissue infections, including cases caused by MRSA. But approval came after the IDSA guidelines were finalized, and that information was not included. Nonetheless, the guidelines note that ceftaroline "may become available in the near future for the treatment" of complicated skin and skin structure infections, Dr. Liu said.

The guidelines do not address active surveillance testing or other strategies aimed at preventing MRSA in health care settings, topics that have been addressed in previously released guidelines.

IDSA funded the development of the guidelines. Of the expert panel's 13 members, 9 reported having potential conflicts of interest that included honoraria or research support from, or having served as a consultant or adviser to, pharmaceutical companies, including Astellas, Cubist Pharmaceutical, Forest, Merck, Ortho-McNeil, Pfizer, Sanofi-Aventis, Schering-Plough, and Theravance. The remaining authors of the guidelines, including the lead author, Dr. Catherine Liu, reported no conflicts.

The Infectious Diseases Society of America rolled out its first-ever guidelines for treating methicillin-resistant Staphylococcus aureus – including recommendations to battle the growing threat posed by MRSA-related skin and soft-tissue infections.

The comprehensive guidelines also outline evidence-based approaches on topics ranging from personal hygiene and wound care to antibiotic therapies for invasive MRSA, as well as options after vancomycin treatment failure.

The guidelines’ primary objective is "to provide recommendations on the management of some of the most common clinical syndromes encountered by adult and pediatric clinicians who care for patients with MRSA infections," according to the executive summary, published online Jan. 5 (Clin. Infect. Dis. 2010 [doi:10.1093/cid/ciq146]).

The guidelines provide adult and pediatric clinicians with guidance on how to treat relatively uncomplicated MRSA infections, as well as more serious infections, according to Dr. Catherine Liu, the guidelines’ lead author and assistant clinical professor in the division of infectious diseases, University of California, San Francisco. The recommendations cover community- and hospital-associated MRSA infections, she added.

MRSA infections account for about 60% of skin infections seen in U.S. emergency departments, and invasive MRSA infections cause about 18,000 deaths a year, according to the Infectious Diseases Society of America (IDSA).

The evidence-based guidelines, which will be published in the Feb. 1 issue of Clinical Infectious Diseases, have been endorsed by the Pediatric Infectious Diseases Society, the American College of Emergency Physicians, and the American Academy of Pediatrics.

The guidelines are voluntary and "are not intended to take the place of a doctor’s judgment, but rather support the decision-making process, which must be individualized according to each patient’s circumstances," according to a statement issued by IDSA, which funded the guidelines.

A 13-member expert panel reviewed hundreds of scientific studies, papers, and presentations to create the recommendations. The guidelines’ sections start with a clinical question, followed by a numbered list of recommendations and a summary of the most relevant evidence to support the recommendations. In most cases, the sections include information on pediatric considerations. The guidelines also highlight areas that are controversial because of limited or conflicting data.

The first topic addressed is the management of skin and soft tissue infections due to MRSA, which have become a significant problem in the past few years, Dr. Liu said in an interview. For example, MRSA is now the predominant organism causing skin infections in patients who present to emergency departments with skin infections, she noted.

The guidelines cover multiple types of skin infections, including abscesses, cellulitis, and more complicated skin infections. The guidelines also offer recommendations on the role of antibiotics, including whether or not they need to be used, situations in which they may not be indicated, and when they definitely should be used. They also offer guidance "on specific types of antibiotic choices that clinicians should consider," Dr. Liu noted.

Other topics covered include the management of MRSA pneumonia, bacteremia, and infective endocarditis; central nervous system infections; and bone and joint infections. Additional sections review the role of adjunctive therapies in the treatment of MRSA infections, MRSA infections in neonates, and specific recommendations on vancomycin dosing and monitoring.

IDSA will update the guidelines as more information and newer antibiotics become available. However, timely updating can be difficult because of the review and publication process, Dr. Liu noted.

For example, the Food and Drug Administration approved the intravenous cephalosporin antibiotic ceftaroline in October 2010 for acute bacterial skin and soft tissue infections, including cases caused by MRSA. But approval came after the IDSA guidelines were finalized, and that information was not included. Nonetheless, the guidelines note that ceftaroline "may become available in the near future for the treatment" of complicated skin and skin structure infections, Dr. Liu said.

The guidelines do not address active surveillance testing or other strategies aimed at preventing MRSA in health care settings, topics that have been addressed in previously released guidelines.

IDSA funded the development of the guidelines. Of the expert panel’s 13 members, 9 reported having potential conflicts of interest that included honoraria or research support from, or having served as a consultant or adviser to, pharmaceutical companies, including Astellas, Cubist Pharmaceutical, Forest, Merck, Ortho-McNeil, Pfizer, Sanofi-Aventis, Schering-Plough, and Theravance. The remaining authors of the guidelines, including the lead author, Dr. Catherine Liu, reported no conflicts.

The Infectious Diseases Society of America rolled out its first-ever guidelines for treating methicillin-resistant Staphylococcus aureus – including recommendations to battle the growing threat posed by MRSA-related skin and soft-tissue infections.

The comprehensive guidelines also outline evidence-based approaches on topics ranging from personal hygiene and wound care to antibiotic therapies for invasive MRSA, as well as options after vancomycin treatment failure.

The guidelines’ primary objective is "to provide recommendations on the management of some of the most common clinical syndromes encountered by adult and pediatric clinicians who care for patients with MRSA infections," according to the executive summary, published online Jan. 5 (Clin. Infect. Dis. 2010 [doi:10.1093/cid/ciq146]).

The guidelines provide adult and pediatric clinicians with guidance on how to treat relatively uncomplicated MRSA infections, as well as more serious infections, according to Dr. Catherine Liu, the guidelines’ lead author and assistant clinical professor in the division of infectious diseases, University of California, San Francisco. The recommendations cover community- and hospital-associated MRSA infections, she added.

MRSA infections account for about 60% of skin infections seen in U.S. emergency departments, and invasive MRSA infections cause about 18,000 deaths a year, according to the Infectious Diseases Society of America (IDSA).

The evidence-based guidelines, which will be published in the Feb. 1 issue of Clinical Infectious Diseases, have been endorsed by the Pediatric Infectious Diseases Society, the American College of Emergency Physicians, and the American Academy of Pediatrics.

The guidelines are voluntary and "are not intended to take the place of a doctor’s judgment, but rather support the decision-making process, which must be individualized according to each patient’s circumstances," according to a statement issued by IDSA, which funded the guidelines.

A 13-member expert panel reviewed hundreds of scientific studies, papers, and presentations to create the recommendations. The guidelines’ sections start with a clinical question, followed by a numbered list of recommendations and a summary of the most relevant evidence to support the recommendations. In most cases, the sections include information on pediatric considerations. The guidelines also highlight areas that are controversial because of limited or conflicting data.

The first topic addressed is the management of skin and soft tissue infections due to MRSA, which have become a significant problem in the past few years, Dr. Liu said in an interview. For example, MRSA is now the predominant organism causing skin infections in patients who present to emergency departments with skin infections, she noted.

The guidelines cover multiple types of skin infections, including abscesses, cellulitis, and more complicated skin infections. The guidelines also offer recommendations on the role of antibiotics, including whether or not they need to be used, situations in which they may not be indicated, and when they definitely should be used. They also offer guidance "on specific types of antibiotic choices that clinicians should consider," Dr. Liu noted.

Other topics covered include the management of MRSA pneumonia, bacteremia, and infective endocarditis; central nervous system infections; and bone and joint infections. Additional sections review the role of adjunctive therapies in the treatment of MRSA infections, MRSA infections in neonates, and specific recommendations on vancomycin dosing and monitoring.

IDSA will update the guidelines as more information and newer antibiotics become available. However, timely updating can be difficult because of the review and publication process, Dr. Liu noted.

For example, the Food and Drug Administration approved the intravenous cephalosporin antibiotic ceftaroline in October 2010 for acute bacterial skin and soft tissue infections, including cases caused by MRSA. But approval came after the IDSA guidelines were finalized, and that information was not included. Nonetheless, the guidelines note that ceftaroline "may become available in the near future for the treatment" of complicated skin and skin structure infections, Dr. Liu said.

The guidelines do not address active surveillance testing or other strategies aimed at preventing MRSA in health care settings, topics that have been addressed in previously released guidelines.

IDSA funded the development of the guidelines. Of the expert panel’s 13 members, 9 reported having potential conflicts of interest that included honoraria or research support from, or having served as a consultant or adviser to, pharmaceutical companies, including Astellas, Cubist Pharmaceutical, Forest, Merck, Ortho-McNeil, Pfizer, Sanofi-Aventis, Schering-Plough, and Theravance. The remaining authors of the guidelines, including the lead author, Dr. Catherine Liu, reported no conflicts.

The Infectious Diseases Society of America rolled out its first-ever guidelines for treating methicillin-resistant Staphylococcus aureus – including recommendations to battle the growing threat posed by MRSA-related skin and soft-tissue infections.

The comprehensive guidelines also outline evidence-based approaches on topics ranging from personal hygiene and wound care to antibiotic therapies for invasive MRSA, as well as options after vancomycin treatment failure.

The guidelines’ primary objective is "to provide recommendations on the management of some of the most common clinical syndromes encountered by adult and pediatric clinicians who care for patients with MRSA infections," according to the executive summary, published online Jan. 5 (Clin. Infect. Dis. 2010 [doi:10.1093/cid/ciq146]).

The guidelines provide adult and pediatric clinicians with guidance on how to treat relatively uncomplicated MRSA infections, as well as more serious infections, according to Dr. Catherine Liu, the guidelines’ lead author and assistant clinical professor in the division of infectious diseases, University of California, San Francisco. The recommendations cover community- and hospital-associated MRSA infections, she added.

MRSA infections account for about 60% of skin infections seen in U.S. emergency departments, and invasive MRSA infections cause about 18,000 deaths a year, according to the Infectious Diseases Society of America (IDSA).

The evidence-based guidelines, which will be published in the Feb. 1 issue of Clinical Infectious Diseases, have been endorsed by the Pediatric Infectious Diseases Society, the American College of Emergency Physicians, and the American Academy of Pediatrics.

The guidelines are voluntary and "are not intended to take the place of a doctor’s judgment, but rather support the decision-making process, which must be individualized according to each patient’s circumstances," according to a statement issued by IDSA, which funded the guidelines.

A 13-member expert panel reviewed hundreds of scientific studies, papers, and presentations to create the recommendations. The guidelines’ sections start with a clinical question, followed by a numbered list of recommendations and a summary of the most relevant evidence to support the recommendations. In most cases, the sections include information on pediatric considerations. The guidelines also highlight areas that are controversial because of limited or conflicting data.

The first topic addressed is the management of skin and soft tissue infections due to MRSA, which have become a significant problem in the past few years, Dr. Liu said in an interview. For example, MRSA is now the predominant organism causing skin infections in patients who present to emergency departments with skin infections, she noted.

The guidelines cover multiple types of skin infections, including abscesses, cellulitis, and more complicated skin infections. The guidelines also offer recommendations on the role of antibiotics, including whether or not they need to be used, situations in which they may not be indicated, and when they definitely should be used. They also offer guidance "on specific types of antibiotic choices that clinicians should consider," Dr. Liu noted.

Other topics covered include the management of MRSA pneumonia, bacteremia, and infective endocarditis; central nervous system infections; and bone and joint infections. Additional sections review the role of adjunctive therapies in the treatment of MRSA infections, MRSA infections in neonates, and specific recommendations on vancomycin dosing and monitoring.

IDSA will update the guidelines as more information and newer antibiotics become available. However, timely updating can be difficult because of the review and publication process, Dr. Liu noted.

For example, the Food and Drug Administration approved the intravenous cephalosporin antibiotic ceftaroline in October 2010 for acute bacterial skin and soft tissue infections, including cases caused by MRSA. But approval came after the IDSA guidelines were finalized, and that information was not included. Nonetheless, the guidelines note that ceftaroline "may become available in the near future for the treatment" of complicated skin and skin structure infections, Dr. Liu said.

The guidelines do not address active surveillance testing or other strategies aimed at preventing MRSA in health care settings, topics that have been addressed in previously released guidelines.

IDSA funded the development of the guidelines. Of the expert panel’s 13 members, 9 reported having potential conflicts of interest that included honoraria or research support from, or having served as a consultant or adviser to, pharmaceutical companies, including Astellas, Cubist Pharmaceutical, Forest, Merck, Ortho-McNeil, Pfizer, Sanofi-Aventis, Schering-Plough, and Theravance. The remaining authors of the guidelines, including the lead author, Dr. Catherine Liu, reported no conflicts.

The Food and Drug Administration has issued a letter to manufacturers of dietary supplements concerning supplements that contain undeclared drugs or drug analogues as their active ingredients.

FDA tests “have revealed an alarming variety of undeclared active ingredients in products marketed as dietary supplements,” including phosphodiesterase type 5 inhibitors, such as sildenafil (Viagra); anticoagulants, such as warfarin; and beta-blockers, such as propranolol, according to the letter. Among the illegally marketed products are those containing drugs that have been withdrawn from the market for safety reasons, including the weight-loss drugs sibutramine (Meridia) and fenfluramine.

Most of the tainted products were found in weight-loss, body-building, and sexual enhancement products.

In addition, the FDA announced a new RSS feed to alert consumers when a tainted product is identified and established new ways for industry to report products suspected of being tainted, either by sending an e-mail to TaintedProducts@fda.hhs.gov

Since 2007, the agency has issued consumer alerts about almost 300 tainted products containing an active drug ingredient. The FDA has received “numerous reports” of adverse events and injuries associated with these products, including stroke, kidney failure, pulmonary embolism, acute liver injury, and death, Dr. Joshua Sharfstein, the FDA's principal deputy commissioner, said during a press briefing announcing the new measures.

The Food and Drug Administration has issued a letter to manufacturers of dietary supplements concerning supplements that contain undeclared drugs or drug analogues as their active ingredients.

FDA tests “have revealed an alarming variety of undeclared active ingredients in products marketed as dietary supplements,” including phosphodiesterase type 5 inhibitors, such as sildenafil (Viagra); anticoagulants, such as warfarin; and beta-blockers, such as propranolol, according to the letter. Among the illegally marketed products are those containing drugs that have been withdrawn from the market for safety reasons, including the weight-loss drugs sibutramine (Meridia) and fenfluramine.

Most of the tainted products were found in weight-loss, body-building, and sexual enhancement products.

In addition, the FDA announced a new RSS feed to alert consumers when a tainted product is identified and established new ways for industry to report products suspected of being tainted, either by sending an e-mail to TaintedProducts@fda.hhs.gov

Since 2007, the agency has issued consumer alerts about almost 300 tainted products containing an active drug ingredient. The FDA has received “numerous reports” of adverse events and injuries associated with these products, including stroke, kidney failure, pulmonary embolism, acute liver injury, and death, Dr. Joshua Sharfstein, the FDA's principal deputy commissioner, said during a press briefing announcing the new measures.

The Food and Drug Administration has issued a letter to manufacturers of dietary supplements concerning supplements that contain undeclared drugs or drug analogues as their active ingredients.

FDA tests “have revealed an alarming variety of undeclared active ingredients in products marketed as dietary supplements,” including phosphodiesterase type 5 inhibitors, such as sildenafil (Viagra); anticoagulants, such as warfarin; and beta-blockers, such as propranolol, according to the letter. Among the illegally marketed products are those containing drugs that have been withdrawn from the market for safety reasons, including the weight-loss drugs sibutramine (Meridia) and fenfluramine.

Most of the tainted products were found in weight-loss, body-building, and sexual enhancement products.

In addition, the FDA announced a new RSS feed to alert consumers when a tainted product is identified and established new ways for industry to report products suspected of being tainted, either by sending an e-mail to TaintedProducts@fda.hhs.gov

Since 2007, the agency has issued consumer alerts about almost 300 tainted products containing an active drug ingredient. The FDA has received “numerous reports” of adverse events and injuries associated with these products, including stroke, kidney failure, pulmonary embolism, acute liver injury, and death, Dr. Joshua Sharfstein, the FDA's principal deputy commissioner, said during a press briefing announcing the new measures.

The Food and Drug Administration’s decision not to approve a computer-assisted personalized sedation system known as the SEDASYS System has been appealed by the manufacturer, Ethicon Endo-Surgery Inc. The device is designed to administer propofol during colonoscopy and esophagogastroduodenoscopy procedures.

Because the manufacturer has appealed the decision, an independent advisory panel will review the decision, but at press time, the date of the review and other details were not available.

In October, the FDA sent a letter to the company denying the approval of the SEDASYS System, which the company had proposed be approved for the intravenous administration of 1% (10 mg/mL) propofol injectable emulsion "for the initiation and maintenance of minimal-to-moderate sedation" in adults undergoing these procedures.

The approval of the device would enable gastroenterologists and nurses to administer propofol to patients during such procedures without an anesthesiologist present; however, the system is not designed for the induction or maintenance of general anesthesia.

According to the FDA, the information submitted by the company "does not provide a reasonable assurance that the device is safe under the conditions of use prescribed, recommended, or suggested in the proposed labeling," and this is why in February 2010, the agency notified the company that the device was not approvable.

But Ethicon Endo-Surgery chose not to address the issues raised by the FDA and chose instead to consider the nonapprovable decision as denial of approval, which, under federal regulations, allows the company to appeal and request an administrative review of the decision by an independent advisory panel.

In November, Ethicon announced that the FDA had granted the company an appeal of the decision and would appoint an independent advisory panel to "reconsider" the clinical trial data and application.

Among the problems with the company’s application cited in the FDA’s October letter were insufficient evidence of the device’s safety in the pivotal study, when used by clinicians who are not trained in the administration of general anesthesia. The study did not compare propofol sedation administered with the SEDASYS system by gastroenterologists and nurses to propofol sedation administered by clinicians trained in general anesthesia, the FDA-approved labeling for the sedative. As a result, the letter says," "we cannot evaluate the distinct risks in administering propofol utilizing the SEDASYS system in comparison with propofol delivery in accordance with FDA-approved drug labeling without the device."

In May 2009, an FDA advisory panel voted 8 to 2 to recommend approval of the device for the indication proposed by the manufacturer, under several conditions, including requiring that clinicians using the device be trained in advanced airway management and that they not be involved in other aspects of the procedure.

Find more information about the FDA’s decision.

The Food and Drug Administration’s decision not to approve a computer-assisted personalized sedation system known as the SEDASYS System has been appealed by the manufacturer, Ethicon Endo-Surgery Inc. The device is designed to administer propofol during colonoscopy and esophagogastroduodenoscopy procedures.

Because the manufacturer has appealed the decision, an independent advisory panel will review the decision, but at press time, the date of the review and other details were not available.

In October, the FDA sent a letter to the company denying the approval of the SEDASYS System, which the company had proposed be approved for the intravenous administration of 1% (10 mg/mL) propofol injectable emulsion "for the initiation and maintenance of minimal-to-moderate sedation" in adults undergoing these procedures.

The approval of the device would enable gastroenterologists and nurses to administer propofol to patients during such procedures without an anesthesiologist present; however, the system is not designed for the induction or maintenance of general anesthesia.

According to the FDA, the information submitted by the company "does not provide a reasonable assurance that the device is safe under the conditions of use prescribed, recommended, or suggested in the proposed labeling," and this is why in February 2010, the agency notified the company that the device was not approvable.

But Ethicon Endo-Surgery chose not to address the issues raised by the FDA and chose instead to consider the nonapprovable decision as denial of approval, which, under federal regulations, allows the company to appeal and request an administrative review of the decision by an independent advisory panel.

In November, Ethicon announced that the FDA had granted the company an appeal of the decision and would appoint an independent advisory panel to "reconsider" the clinical trial data and application.

Among the problems with the company’s application cited in the FDA’s October letter were insufficient evidence of the device’s safety in the pivotal study, when used by clinicians who are not trained in the administration of general anesthesia. The study did not compare propofol sedation administered with the SEDASYS system by gastroenterologists and nurses to propofol sedation administered by clinicians trained in general anesthesia, the FDA-approved labeling for the sedative. As a result, the letter says," "we cannot evaluate the distinct risks in administering propofol utilizing the SEDASYS system in comparison with propofol delivery in accordance with FDA-approved drug labeling without the device."

In May 2009, an FDA advisory panel voted 8 to 2 to recommend approval of the device for the indication proposed by the manufacturer, under several conditions, including requiring that clinicians using the device be trained in advanced airway management and that they not be involved in other aspects of the procedure.

Find more information about the FDA’s decision.

The Food and Drug Administration’s decision not to approve a computer-assisted personalized sedation system known as the SEDASYS System has been appealed by the manufacturer, Ethicon Endo-Surgery Inc. The device is designed to administer propofol during colonoscopy and esophagogastroduodenoscopy procedures.

Because the manufacturer has appealed the decision, an independent advisory panel will review the decision, but at press time, the date of the review and other details were not available.

In October, the FDA sent a letter to the company denying the approval of the SEDASYS System, which the company had proposed be approved for the intravenous administration of 1% (10 mg/mL) propofol injectable emulsion "for the initiation and maintenance of minimal-to-moderate sedation" in adults undergoing these procedures.

The approval of the device would enable gastroenterologists and nurses to administer propofol to patients during such procedures without an anesthesiologist present; however, the system is not designed for the induction or maintenance of general anesthesia.

According to the FDA, the information submitted by the company "does not provide a reasonable assurance that the device is safe under the conditions of use prescribed, recommended, or suggested in the proposed labeling," and this is why in February 2010, the agency notified the company that the device was not approvable.

But Ethicon Endo-Surgery chose not to address the issues raised by the FDA and chose instead to consider the nonapprovable decision as denial of approval, which, under federal regulations, allows the company to appeal and request an administrative review of the decision by an independent advisory panel.

In November, Ethicon announced that the FDA had granted the company an appeal of the decision and would appoint an independent advisory panel to "reconsider" the clinical trial data and application.

Among the problems with the company’s application cited in the FDA’s October letter were insufficient evidence of the device’s safety in the pivotal study, when used by clinicians who are not trained in the administration of general anesthesia. The study did not compare propofol sedation administered with the SEDASYS system by gastroenterologists and nurses to propofol sedation administered by clinicians trained in general anesthesia, the FDA-approved labeling for the sedative. As a result, the letter says," "we cannot evaluate the distinct risks in administering propofol utilizing the SEDASYS system in comparison with propofol delivery in accordance with FDA-approved drug labeling without the device."

In May 2009, an FDA advisory panel voted 8 to 2 to recommend approval of the device for the indication proposed by the manufacturer, under several conditions, including requiring that clinicians using the device be trained in advanced airway management and that they not be involved in other aspects of the procedure.

Find more information about the FDA’s decision.