WASHINGTON – The Food and Drug Administration has taken too long to review and approve new sunscreen ingredients and should be required to clear its current backlog within 8 months and review new products within 11 months, members of Congress said at a hearing April 7.
"Everyone seems to agree that the current system for approving sunscreen ingredients is broken," Rep. Fred Upton (R-Mich.), chairman of the House Energy & Commerce Committee, said at a hearing of his committee’s Subcommittee on Health. H.R. 4250, the Sunscreen Innovation Act, "would help provide a solution to the current backlog of sunscreen ingredients pending at the FDA."
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Legislators have complained that it takes the FDA too long to review and approve new ingredients in sunscreen.
Currently, eight sunscreen ingredients are under review by the FDA, many of which have been approved for use in other countries; some reviews have been ongoing for 3-11 years.
H.R. 4250 was introduced March 13 in the House by Rep. Ed Whitfield (R-Ky.) and Rep. John Dingell (D-Mich.) and as S. 2141 the same day in the Senate by Sen. Jack Reed (D-R.I.) and Sen. Johnny Isakson (R-Ga.).
In addition to eliminating the backlog, the bill would align the sunscreen review process more closely with the new-drug and device approval process. Under the legislation, the FDA Nonprescription Drugs Advisory Committee would review the safety and efficacy of the ingredient and make a recommendation on approval. The FDA would have 45 days to make the final decision for approval.
Rep. Henry Waxman (D-Calif.) said that he worried this would essentially give an advisory committee the power to make an approval decision if the FDA did not act. That would set a bad precedent, said Rep. Waxman, who added that he otherwise supported the Sunscreen Innovation Act.
The American Academy of Dermatology Association supported the legislation.
"A more timely review process has the potential to reduce Americans’ risk for skin cancer by ensuring that they have access to the safest, most effective sunscreens available," Dr. Brett M. Coldiron, AAD president, said in a statement.
Dr. Janet Woodcock, director of the FDA Center for Drug Evaluation and Research, said that she agreed that the process should be modernized and that it was no longer serving consumers, manufacturers, or the agency itself.
As Americans have gone from occasional and limited use of sunscreen products to year-round and heavier use of them, new questions have been raised about the short- and long-term effects of these products, Dr. Woodcock said. The FDA "has been actively examining the important scientific questions," such as whether there is systemic exposure to an ingredient, or if an ingredient might be an endocrine disrupter.
The FDA recently sent letters to the makers of two sunscreen ingredients – amiloxate and diethylhexyl butamido triazone – noting that the evidence is not sufficient to establish safety and efficacy, Dr. Woodcock said. The agency is still reviewing six other sunscreen ingredients.
The FDA will hold a public hearing later this year to clarify what information it is seeking to establish the safety and efficacy of sunscreen ingredients, she added.
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