S. 2141, Sunscreen Innovation Act

S. 2141

Sunscreen Innovation Act

Sponsor
Sen. Jack Reed

Date
November 13, 2014 (113th Congress, 2nd Session)

Staff Contact
Communications

Floor Situation

On Thursday, November 13, 2014, the House will consider S. 2141, the Sunscreen Innovation Act.  S. 2141 was introduced on March 13, 2014 by Sen. Jack Reed (D-RI) and passed in the Senate by unanimous consent.

Bill Summary

S. 2141, the Sunscreen Innovation Act, would address the current backlog of applications for nonprescription sunscreen active ingredients pending at the Food and Drug Administration (FDA) by establishing a new review and approval process. In addition, this legislation establishes a predictable and transparent review process for new applications, incorporating meaningful input from experts and the public. S. 2141 also allows sponsors of eligible non-sunscreen over-the-counter drug applications to request the Secretary provide a framework for review of their application.

This legislation directs the Comptroller General, within three years of enactment, to report on the progress of the Secretary in establishing the process laid out in this legislation and the role of the Commissioner of the FDA in issuing determinations on pending requests.   Finally, it requires the Secretary to, within 18 months, report on: 1) decisions made about the safety and efficacy of sunscreen active ingredients; 2) the amount of time between submission and decision for each request; 3) the cost of the review process; and 4) recommended improvements to the review process.  This will ensure accountability regarding the progress of implementation.

Background

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.[1]  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.[2]  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.

A similar version of this legislation, H.R. 4250, passed in the House on July 28, 2014 by voice vote.

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[1] http://whitfield.house.gov/media-center/press-releases/markup-notice-sunscreen-innovation-act
[2] See Id.

Cost

The CBO estimates that implementing this legislation would cost $35 million over the 2015-2019 period, assuming the appropriation of the necessary amounts.[3]  Enacting H.R. 4250 would not affect direct spending or revenues.

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[3] https://www.cbo.gov/sites/default/files/cbofiles/attachments/s2141.pdf

Additional Information

For questions or further information contact the GOP Conference at 5-5107.