US President Barack Obama has signed into law a new bill set to change the way in which some drugs, and in particular sunscreen ingredients long approved in other countries, are regulated by the US Food and Drug Administration (FDA).
The bill, the Sunscreen Innovation Act (SIA), was signed into law by Obama on 26 November 2014 following its passage in the House of Representatives on 14 November 2014.
The bill's passage follows extensive complaints by several companies that their sunscreen products 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 Time-and-Extent (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:
- Sponsor must generate a TEA application, including information about the drug, the time and extent of its marketing and its use.
- 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?
- The TEA submission is then opened to public comment, including comment from rival manufacturers and public interest groups.
- FDA determines whether the ingredient is generally regarded as safe and effective (GRASE), and thus eligible under the monograph system.
- 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.
Sunscreen Innovation Act
The Sunscreen Innovation Act, as envisioned by its sponsors, is intended to reform FDA's TEA process to expedite the review and approval of all TEA products, and in particular those products containing new sunscreen ingredients.
Much of the legislation is geared toward ensuring sponsors of TEAs get timely and predictable responses. For example, FDA will be required to notify TEA sponsors within 60 days of the submission of an application as to whether the application is sufficiently complete to support a review by regulators.
The law also calls for FDA to speed up its publication of its responses to TEAs. The agency will be tasked with acting on most applications within the next three months, though there's no guarantee it will approve any applications.
FDA is also ordered to produce a guidance document to clarify how sponsors can get their sunscreen products approved by FDA and the data FDA will require prior to an approval decision.
The law also pressures FDA to issue a new sunscreen monograph within 5 years of the legislation's passage. Such a monograph would clear the way for new sunscreen products by declaring their base ingredients GRASE, allowing them to skip FDA's arduous approvals process so long as they conform to the monograph.
Notably, the law also contains new reforms aimed at "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.
Sunscreen Innovation Act
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