On Monday, July 28, 2014, the House will consider H.R. 4250, the Sunscreen Innovation Act, under a suspension of the rules. H.R. 4250 was introduced on March 3, 2014 by Rep. Ed Whitfield (R-KY) and referred to the Committee on Energy and Commerce, which ordered the bill reported, as amended, by voice vote.
H.R. 4250, the Sunscreen Innovation Act, would address the current backlog of applications for nonprescription sunscreen active ingredients pending at the Food and Drug Administration (FDA) as well as establish a predictable and transparent review process for new applications, incorporating meaningful input from experts and the public.
To ensure accountability, H.R. 4250 requires the FDA to write at least 3 reports to Congress regarding the progress of implementation prior to the 5 year sunset of the legislation.
Skin cancer is a public health crisis in the United States. Each year there are more new cases of skin cancer than the combined incidence of breast, prostate, lung, and colon cancer and by 2015, it is estimated that one in fifty Americans will develop melanoma in their lifetime.
The FDA has not approved a new nonprescription sunscreen ingredient in nearly two decades, despite the fact that several applications have been pending at the agency for years. The FDA has listed action on sunscreen ingredient applications as a priority since 2008 in the Unified Agenda, however no new sunscreen ingredients have received a decision from FDA. The pre-existing time and extent application (TEA) process did not include deadlines for the timely review of such ingredients, which this bill would establish. Further, it would remove administrative hurdles identified by FDA to the sunscreen approval process and ensure sunscreens receive a transparent review within a predictable timeframe.
The CBO estimates that implementing this legislation would cost $28 million over the 2015-2019 period, assuming the appropriation of the necessary amounts. Enacting H.R. 4250 would not affect direct spending or revenues.
For questions or further information contact the GOP Conference at 5-5107.