Sunscreen Innovation Act Starts Clock Ticking On FDA Review Of TEAs

Congress passes legislation to provide an alternative process for reviewing UV filters to be added to the OTC drug sunscreen monograph. The bill’s passing during Congress’ lame duck session reflects not only bipartisan support, but also lobbying by the personal care product industry and consumer health advocates to impose deadlines on FDA for long-sought changes to the sunscreen monograph.

Congress passes the Sunscreen Innovation Act with hard deadlines for FDA review of time and extent applications for sunscreen ingredients and an expedited pathway for reviews of other OTC ingredient TEAs.

The House on Nov. 13 by unanimous consent passed the Senate version of the legislation, S. 2141, to amend the Food, Drug and Cosmetic Act to provide an alternative process for review of UV filters considered as generally regarded as safe and effective and eligible for the OTC drug sunscreen monograph.

The bill’s passing during Congress’ lame duck session following the mid-term elections reflects not only bipartisan support for the legislation, but also lobbying by personal care product industry and consumer health advocates to give FDA deadlines for long-sought changes to the sunscreen monograph.

The Senate bill approved in September differed from of a House version passed in July, H.R. 4250, by including TEAs for all OTC monograph ingredients rather than being limited to sunscreen ingredients (Also see "Senate Passes Bill With FDA Review Deadlines For All OTC TEAs" - Pink Sheet, 18 Sep, 2014.).

“It has been far too long since the United States has approved any new sunscreen ingredients,” Rep. Ed Whitfield, R-KY, an author of the House bill, said in a statement.

The president, with improving health care and public health a cornerstone of his administration, is expected to sign the bill.

The act also requires FDA to publish proposed regulations with timelines for TEA reviews of other OTC ingredients within 18 months of the bill being signed into law. Those timelines “may vary based on the content, complexity, and format of the application,” according to the act.

Sponsors of other OTC ingredient TEAs already found eligible to be evaluated for inclusion in the monograph system can ask FDA to provide a review framework. Those requests should be made within 180 days of the act’s enactment because within one year FDA is required to provide “a framework to each sponsor that submitted a request,” according to the bill.

Also required from FDA is a report within 18 months to the Senate Health, Education, Labor and Pensions Committee on the review timeline and GRASE determination for each pending application.

TEAs Languish No Longer

The act requires FDA to determine whether a sunscreen TEA is eligible for review within 60 days of receiving it; if the agency refuses to accept a TEA for review, the sponsor within 30 days can request a meeting with FDA officials to discuss the decision.

For sunscreen TEAs accepted for review, FDA will:

• allow 45 days for public comment supporting or otherwise relating to an ingredient’s GRASE determination
• within 60 days of a comment period ending, determine whether a sponsor’s data and other information “are sufficiently complete, including being formatted in a manner that enables [the agency] to determine the completeness of such data and information[and] conduct a substantive review”
• within 300 days complete the review and issue a proposed sunscreen order either approving or rejecting the ingredient for addition to the monograph, or convene an advisory committee meeting to review a request

After FDA publishes a proposed order and allows-a 45-day comment period, the agency has 90 days to issue a final order on whether an ingredient is approved or rejected for a monograph.

However, when FDA determines a sponsor’s data are insufficient and additional information is necessary to determine whether a proposed sunscreen ingredient is GRASE, the agency must issue a final rule within 210 days if an advisory committee meeting is not conducted, or 270 days if an advisory committee discusses a TEA.

Industry stakeholders welcome the act to make available sunscreen filters that have languished in FDA’s evaluation system for years despite being approved for use in European and other markets.

The TEA process was established in 2002 as a pathway for expanding OTC monographs with additional ingredients that have been marketed “to a material extent and for a material time” – for instance in a foreign country – and have supporting safety data from that experience.

Eight sunscreen TEAs have been under FDA review, with some pending with the agency for more than a decade. FDA this year stepped up its review efforts, but issued insufficient-data findings to sponsors of five applications while inviting additional data in support of their sunscreen ingredients.

One of the applications is from BASF Corp., which released a statement Nov. 14 on Congress passing the act. The firm has proposed its Tinosorb and Uvinul UV filters for the sunscreen monograph.

“If signed by President Obama, the Sunscreen Innovation Act will help provide Americans access to the latest sunscreen ingredients, some of which have been widely available for 15 years in Europe, Asia and Latin America,” the Florham Park, N.J.-based U.S. division of BASF SE states.

The Public Access to SunScreens Coalition of industry and consumer advocate representatives also lauded passage of the act, saying it is “confident that the [act] will enable Americans to have greater choice when it comes to protecting their skin from the sun's harmful UVA and UVB rays.”