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The Food and Drug Administration has released final industry guidance for nonclinical sunscreen manufacturers, but comments from a top agency official bring into question the pace of progress for getting the products to market.
A 2014 law, the Sunscreen Innovation Act, was intended to speed approval of new sunscreen active ingredients; one impetus for its passage was that no new sunscreen active ingredient has been approved since the late 1990s.
During that time, eight applications for new sunscreen active ingredients languished at the agency, even though many, such as UV filters bisoctrizole and bemotrizinol, are widely available across Europe and elsewhere. The law gave the FDA 1 year to review the backlog of applications for the ingredients and gave the agency 18 months to act on any sunscreen ingredient application submitted after the law went into effect.
“The FDA has issued proposed sunscreen orders identifying data we believe is necessary for the agency to make a positive [generally regarded as safe and effective] determination on those within the [law’s] required time frame, but has yet to receive the additional data we requested” from sunscreen ingredient manufacturers, Theresa M. Michele, MD, director of the FDA’s Division of Nonprescription Drug Products, wrote in a blog post.
To help, the agency has just released the final two of four industry guidance documents. The first addresses the agency’s current thinking on what constitutes a generally safe and effective sunscreen ingredient, while the second outlines data submission procedures. Previous guidance addressed procedural matters.
Specifically, the FDA wants to see evidence that these ingredients aren’t toxic over time, something that requires clinical trials in humans.
“The FDA and industry are essentially at a standstill because industry feels that there is a significant amount of resources they have to [invest] in order to comply with these testing regulations,” Dr. Lim said in an interview. “Industry is not willing to do it.”
In Europe and many other countries, sunscreens are considered cosmetics. The FDA considers them over-the-counter drugs and holds them to a higher approval standard. Although the 2014 law allows the FDA to review 5 years or more of marketing history for ingredients that are in use outside the United States, current approval standards require human absorption data derived from maximal usage trials to determine the risk of chronic exposure to products applied over large areas of the body, Dr. Michele said in a statement. “It is the same standard used by the FDA for all topically applied drugs, and especially for drugs that are used routinely over the course of one’s life.”
Dr. Lim said that the AAD is working as a neutral party to help both sides arrive at a compromise, and that a meeting between FDA and industry officials is scheduled for early 2017. However, he said that he thinks it is “not likely” that the FDA would ever relax its approval process to view sunscreens at the level of cosmetics as is done abroad, since that would mean different sets of standards for the same class of product. “Knowing how the FDA works, this is not going to happen,” Dr. Lim said.
“The FDA is committed to helping ensure that sunscreens are safe and effective for U.S. consumers, but we need data to move forward,” Dr. Michele wrote.
Dr. Lim disclosed that he is a consultant for Pierre Fabre and an investigator for Allergan, Estee Lauder, and Ferndale.
The Food and Drug Administration has released final industry guidance for nonclinical sunscreen manufacturers, but comments from a top agency official bring into question the pace of progress for getting the products to market.
A 2014 law, the Sunscreen Innovation Act, was intended to speed approval of new sunscreen active ingredients; one impetus for its passage was that no new sunscreen active ingredient has been approved since the late 1990s.
During that time, eight applications for new sunscreen active ingredients languished at the agency, even though many, such as UV filters bisoctrizole and bemotrizinol, are widely available across Europe and elsewhere. The law gave the FDA 1 year to review the backlog of applications for the ingredients and gave the agency 18 months to act on any sunscreen ingredient application submitted after the law went into effect.
“The FDA has issued proposed sunscreen orders identifying data we believe is necessary for the agency to make a positive [generally regarded as safe and effective] determination on those within the [law’s] required time frame, but has yet to receive the additional data we requested” from sunscreen ingredient manufacturers, Theresa M. Michele, MD, director of the FDA’s Division of Nonprescription Drug Products, wrote in a blog post.
To help, the agency has just released the final two of four industry guidance documents. The first addresses the agency’s current thinking on what constitutes a generally safe and effective sunscreen ingredient, while the second outlines data submission procedures. Previous guidance addressed procedural matters.
Specifically, the FDA wants to see evidence that these ingredients aren’t toxic over time, something that requires clinical trials in humans.
“The FDA and industry are essentially at a standstill because industry feels that there is a significant amount of resources they have to [invest] in order to comply with these testing regulations,” Dr. Lim said in an interview. “Industry is not willing to do it.”
In Europe and many other countries, sunscreens are considered cosmetics. The FDA considers them over-the-counter drugs and holds them to a higher approval standard. Although the 2014 law allows the FDA to review 5 years or more of marketing history for ingredients that are in use outside the United States, current approval standards require human absorption data derived from maximal usage trials to determine the risk of chronic exposure to products applied over large areas of the body, Dr. Michele said in a statement. “It is the same standard used by the FDA for all topically applied drugs, and especially for drugs that are used routinely over the course of one’s life.”
Dr. Lim said that the AAD is working as a neutral party to help both sides arrive at a compromise, and that a meeting between FDA and industry officials is scheduled for early 2017. However, he said that he thinks it is “not likely” that the FDA would ever relax its approval process to view sunscreens at the level of cosmetics as is done abroad, since that would mean different sets of standards for the same class of product. “Knowing how the FDA works, this is not going to happen,” Dr. Lim said.
“The FDA is committed to helping ensure that sunscreens are safe and effective for U.S. consumers, but we need data to move forward,” Dr. Michele wrote.
Dr. Lim disclosed that he is a consultant for Pierre Fabre and an investigator for Allergan, Estee Lauder, and Ferndale.
The Food and Drug Administration has released final industry guidance for nonclinical sunscreen manufacturers, but comments from a top agency official bring into question the pace of progress for getting the products to market.
A 2014 law, the Sunscreen Innovation Act, was intended to speed approval of new sunscreen active ingredients; one impetus for its passage was that no new sunscreen active ingredient has been approved since the late 1990s.
During that time, eight applications for new sunscreen active ingredients languished at the agency, even though many, such as UV filters bisoctrizole and bemotrizinol, are widely available across Europe and elsewhere. The law gave the FDA 1 year to review the backlog of applications for the ingredients and gave the agency 18 months to act on any sunscreen ingredient application submitted after the law went into effect.
“The FDA has issued proposed sunscreen orders identifying data we believe is necessary for the agency to make a positive [generally regarded as safe and effective] determination on those within the [law’s] required time frame, but has yet to receive the additional data we requested” from sunscreen ingredient manufacturers, Theresa M. Michele, MD, director of the FDA’s Division of Nonprescription Drug Products, wrote in a blog post.
To help, the agency has just released the final two of four industry guidance documents. The first addresses the agency’s current thinking on what constitutes a generally safe and effective sunscreen ingredient, while the second outlines data submission procedures. Previous guidance addressed procedural matters.
Specifically, the FDA wants to see evidence that these ingredients aren’t toxic over time, something that requires clinical trials in humans.
“The FDA and industry are essentially at a standstill because industry feels that there is a significant amount of resources they have to [invest] in order to comply with these testing regulations,” Dr. Lim said in an interview. “Industry is not willing to do it.”
In Europe and many other countries, sunscreens are considered cosmetics. The FDA considers them over-the-counter drugs and holds them to a higher approval standard. Although the 2014 law allows the FDA to review 5 years or more of marketing history for ingredients that are in use outside the United States, current approval standards require human absorption data derived from maximal usage trials to determine the risk of chronic exposure to products applied over large areas of the body, Dr. Michele said in a statement. “It is the same standard used by the FDA for all topically applied drugs, and especially for drugs that are used routinely over the course of one’s life.”
Dr. Lim said that the AAD is working as a neutral party to help both sides arrive at a compromise, and that a meeting between FDA and industry officials is scheduled for early 2017. However, he said that he thinks it is “not likely” that the FDA would ever relax its approval process to view sunscreens at the level of cosmetics as is done abroad, since that would mean different sets of standards for the same class of product. “Knowing how the FDA works, this is not going to happen,” Dr. Lim said.
“The FDA is committed to helping ensure that sunscreens are safe and effective for U.S. consumers, but we need data to move forward,” Dr. Michele wrote.
Dr. Lim disclosed that he is a consultant for Pierre Fabre and an investigator for Allergan, Estee Lauder, and Ferndale.