Sunscreen Innovation Act Advances in House, Seeks FDA Action on New Ingredients

Regulatory NewsRegulatory News
| 18 June 2014 | By Alexander Gaffney, RAC

Legislators are preparing to move forward with legislation that would require the US Food and Drug Administration (FDA) to take action on the approval of new sunscreen ingredients, a collection of which have been pending before the agency for years, and in some cases more than a decade.


HR 4250, known as the Sunscreen Innovation Act, is co-sponsored by Reps. Ed Whitfield (R-KY) and John Dingell (D-MI) and required FDA legislators to speed up their review of sunscreen ingredients submitted under the Time-and-Extent Application (TEA) process.

That process allows companies to submit applications for approval (based on amending existing monographs) based not on original clinical trials data, but instead based on a product's record of safe use in another country or regulatory region, such as the EU.

Sponsors of TEAs must undergo a five-part process, any part of which can experience lengthy delays:

  1. Sponsor must generate a TEA application, including information about the drug, the time and extent of its marketing, and its use.
  2. FDA must then determine if the drug is eligible under the monograph system. In essence: Would this drug be able to be used without the supervision of a healthcare professional by most people?
  3. The TEA submission is then opened to public comment, including comment from rival manufacturers and public interest groups.
  4. FDA determines whether the ingredient is generally regarded as safe and effective (GRASE), and thus eligible under the monograph system.
  5. FDA then proposes and later finalizes a regulation (rule) on adding the drug ingredient to the sunscreen monograph. In some cases, it also publishes an advanced notice of public rulemaking, which is a notice that it plans to issue a draft regulation in the future.

At present, there are at least eight ingredients pending before FDA, all of which are seeking approval under the TEA process. The problem for some of those ingredients: Sunscreen ingredients are regulated as cosmetic products in the EU, but as drugs in the US, meaning some products don't have much data regarding their safety or efficacy—or at least not data meeting FDA's expectations.

The result has been years of delays. At least three ingredients have been awaiting FDA approval since 2003, while two others have been awaiting approval since 2005. Three others have been on hold since 2006, 2008 and 2010, respectively.

For more on the regulation of sunscreen ingredients, please read Focus' Regulatory Explainer on the topic.


The Sunscreen Innovation Act would change this by requiring FDA to review all sunscreen ingredients that would be eligible under the TEA process through an expedited process. That process would see applications reviewed in a timeframe measured in months instead of years. Even accounting for delays (such as FDA seeking additional data), most submissions would likely be able to receive approval within two years of submission.

The law calls for existing applications to be reviewed within 8 months, and new submissions to be reviewed within 11 months, FDA Law Blog reported.

An advisory committee would also review all drugs submitted through the sunscreen TEA pathway.

FDA would also be charged with developing testing and labeling requirements for sunscreens sold as an aerosol, and also charged to revisit whether sunscreen may be labeled with a sun protection factor (SPF) greater than the current limit of 50.

The legislation is somewhat unusual in the current partisan climate of Washington, DC. It has enjoyed wide support across the ideological spectrum. A companion version of the bill by the same name (S.2141) has also been introduced in the Senate and enjoys bipartisan support.

Bill Advancing with Broad Support

But since the legislation's introduction in March 2014, little has been done to publicly advance the bill.

That is, until now.

On 17 June 2014, the House Energy and Commerce Committee's Subcommittee on Health announced that it will soon convene a meeting that will mark up (i.e. accept amendments to) several pieces of legislation, including the Sunscreen Innovation Act.

"The FDA has not approved a new sunscreen ingredient in nearly two decades," the committee's Republican members wrote in a statement. "This legislation would require that pending and new applications be completed in a more predictable and transparent manner."

The markup of the bill will occur on 19 June 2014, the committee said. The committee did not say if it will vote to advance the bill out of committee on the same day, but it likely will based on activity at past committee markups.

If the bill passes the Energy and Commerce Committee's Subcommittee on Health, it will still need to pass a vote before the full Energy and Commerce Committee, and then the full House of Representatives.

The bill currently has 32 sponsors and co-sponsors in the House, and 12 sponsors and co-sponsors in the Senate, giving it relatively good odds to pass both chambers of Congress.


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