US legislators in the House of Representatives have passed a Senate bill which would overhaul the manner in which the US Food and Drug Administration (FDA) approves sunscreen ingredients and other products through a rarely used regulatory pathway known as the Time-and-Extent process (TEA), all but assuring the bill will be passed into law.

Background

The bill, known as the Sunscreen Innovation Act (SIA), follows extensive complaints by several companies that their sunscreen products—long marketed in other countries—have been unnecessarily held up by FDA officials.

For a thorough explanation of this, please see Focus' explainer on the regulation of sunscreen ingredients.

Those products have been seeking to access the market as over-the-counter (OTC) drugs through FDA's TEA process—a rarely used procedure meant to allow products to be approved for use in the US based on their use in other countries.

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.

While the TEA process is meant to be speedy in concept, in practice it has proven to be anything but. Since FDA lacks the data it often relies upon for approvals, it has delayed some ingredients for nearly a decade, seeking more and better data in support of TEA applications. In addition, because products are approved in different ways across regions—sunscreen ingredients are actually cosmetics in the EU—it can often be difficult to rely upon data from outside the US.

House Version of the Sunscreen Innovation Act

An early iteration of the Sunscreen Innovation Act introduced in the House of Representatives was intended to reform the TEA process, but only as it specifically applied to sunscreen ingredients.

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

Differences in Senate Bill

The Senate, however, introduced a more expansive version of the bill in September containing mostly identical language to the House bill but also focusing on "non-sunscreen" TEAs.

The bill specifically calls for FDA to issue regulations within 18 months of the bill's passage to provide for the "timely and efficient" review of TEA applications "for drugs other than nonprescription sunscreen active ingredients or combinations of nonprescription sunscreen active ingredients." The regulations are to set "reasonable timelines" for the review and approval of medications and also provide "measurable metrics" for ensuring those goals are met.

The guidelines may, however, "vary based on the content, complexity and format of the application submitted." That's important for FDA regulators, who have highlighted major data deficiencies in some TEA applications. Some sunscreen ingredients, for example, are actually regulated as cosmetic products in other countries, meaning FDA sometimes has little or insufficient data to support findings of safety or efficacy.

Bill Passage

Now the bill, approved by the Senate since 17 September 2014, has passed the House as well, clearing its way for approval from President Barack Obama. The bill was passed in the house "without objection," according to congressional records.

The bill is expected to be signed into law after receiving overwhelming support in both the House and Senate, giving it the ability to overcome a veto of the bill by the president in the unlikely event that such a veto occurred.

Sunscreen Innovation Act (S.2141)