The House Energy & Commerce Committee has approved a bill that aims to speed up Food and Drug Administration approval of new sunscreen ingredients and eliminate the backlog that has kept some ingredients off the market for a decade.
The Sunscreen Innovation Act (H.R. 4250) was approved by the committee on a voice vote. An amendment to establish timeframes for how quickly the FDA must initially review applications and provide final decisions was added by one of the bill’s main sponsors, Rep. Ed Whitfield (R-Ky.).
© Vesna Andjic/iStockphoto.com
The proposed bill could speed up FDA action on new sunscreen ingredients awaiting approval.
"We thought it was essential we try to resolve and speed up this approval process while at same time still protecting the health of the American people," said Rep. Whitfield at the meeting convened to vote on the legislation. He said that the timeframes in his amendment had been agreed upon by the FDA, the Public Access to SunScreens (PASS) Coalition, and various manufacturers and consumer advocates.
The bill now would require the FDA to notify the manufacturer within 60 days of submission whether its application was acceptable, or whether more data were needed. It would then allow a public comment period for 45 days. Overall, the FDA would have 300 days to review a new sunscreen ingredient. If the agency deemed it not approvable, it would be required to hold an advisory committee meeting within that 300-day period.
At a June meeting on the legislation, Energy & Commerce Committee chairman Fred Upton (R-Mich.) noted that there had not been a new sunscreen ingredient approved in the United States in 20 years.
Before the full committee vote, Rep. Bob Latta (R-Ohio) said that eight new ingredients had been awaiting review at the FDA for a dozen years and that many of those products were produced in the United States but shipped overseas "because of the regulatory inaction by the FDA." The bill will help eliminate that backlog and bring sunscreens available in foreign markets to America, said Rep. Latta.
The legislation also is "extremely important as melanoma is a prevalent form of cancer in this country," he said, noting a 400% increase in the last several decades. He also noted that Ohio ranks in top 10 states for melanoma deaths in the United States.
"Americans should have access to the best products to protect themselves from this terrible disease," he said.
The bill now awaits the approval of the full House, and then must be approved by the Senate.