The Senate unanimously approved a bill designed to speed up Food and Drug Administration approval of sunscreen ingredients, adding to the likelihood that the legislation will become law.
The full Senate took quick action on Sept. 17, the same day that the Health, Education, Labor & Pensions (HELP) Committee unanimously voted 12-0 in favor of the Sunscreen Innovation Act (S.2141).
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“We have a number of ingredients for sunscreens that have languished at the FDA for years – as long as a decade,” Sen. Johnny Isakson (R-Ga.), a cosponsor of the bill, said at the HELP hearing. “This doesn’t mean Congress makes the decision,” he said, adding that, instead, the law does establish time frames for review.
The legislation “is also about holding the FDA accountable to timelines and reforming the process,” said Sen. Lamar Alexander (R-Tenn.).
The bill would require the FDA to make final decisions within a year on the backlog of ingredients under review, and within a year and a half on new applications. It also sets up more congressional oversight.
At a recent FDA advisory committee hearing on sunscreen ingredient safety, Dr. Theresa Michele, an FDA official, said that eight ingredients were awaiting approval through what was supposed to be an expedited process. These are the same ingredients that have been under review for 10 years or more. The agency has responded to manufacturers of five of the eight, telling them that so far, there’s not enough data to determine whether they can be marketed, said Dr. Michele.
The Senate joins the House in calling on the FDA to move those approvals along. The full House approved companion legislation (H.R.4250) in late July.
The legislation is supported by the American Academy of Dermatology and by consumer advocates and manufacturers, including the Public Access to SunScreens (PASS) Coalition.
“Congress’s commitment to addressing the skin cancer epidemic in the United States was clearly demonstrated in tonight’s Senate passage of the Sunscreen Innovation Act,” said Michael Werner, PASS Coalition Policy Adviser, in a statement after the vote. “We now call on the House and Senate to swiftly reconcile the differences in their bills and enact final legislation,” Werner said.
Chris Hansen, president of the American Cancer Society Cancer Action Network, said in a statement that if the bill became law, it would add more predictability to FDA reviews.
“The Senate took a critical step yesterday to fix a broken process at FDA for the review of new sunscreen ingredients that could potentially help more Americans prevent skin cancer,” he said.
Tim Turnham, executive director of the Melanoma Research Foundation, said in a statement that some of the ingredients under FDA review have been widely available in Europe, Asia, and Central and South America, in some cases for more than 15 years.
“Americans are limited in their choices for compounds that block UV radiation because of the long-standing bureaucratic gridlock at the FDA that prevents new agents from being approved,” said Mr. Turnham.
The House and Senate have to reconcile the two versions of the bill, and then the legislation will have to be approved again by both bodies before being sent to the White House for final approval.
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