On November 26, 2014, the Sunscreen Innovation Act (S. 2141) was approved by President Obama and became law. The Sunscreen Innovation Act is intended to streamline the process by which the FDA will review new sunscreen ingredients.
The following is a summary of some of the key features of the Act:
- Any person may request that the Secretary of Health and Human Services (HHS) determine whether an OTC sunscreen active ingredient or combination of ingredients is safe and effective.
- The Secretary must review any request regarding a sunscreen active ingredient or combination of ingredients that has been in use and that is not included in the sunscreen monograph published by the Food and Drug Administration (FDA).
- Directs the Secretary to invite the sponsor of the request to provide data and other information on the safety and efficacy of the sunscreen active ingredient or combination of ingredients. Requires the Secretary to determine whether the provided information is sufficient to conduct a review, and if so, file the request, and if not, explain to the sponsor why the provided information is insufficient.
- The Director of the Center for Drug Evaluation and Research must complete a review of a newly filed request and determine the safety and efficacy of the sunscreen active ingredient or combination of ingredients within 300 days for new requests, and a much shorter time frame for pending requests that were submitted prior to the Act’s enactment.
- For pending requests pending before enactment of the Act, if a letter was previously issued under the administrative procedures for classifying OTC drugs as GRASE (21 CFR 330.14(g)), the letter will be deemed a proposed sunscreen order and be published within 45 days after the Act’s enactment. If a letter was not previously issued, then the FDA has 90 days to issue a proposed sunscreen order with respect to the ingredient’s GRASE determination.
- If a determination is not made and a proposed order not issued within these time frames, then the sponsor can notify the Commissioner of Food and Drugs and request that the Commissioner make the determination. The Commissioner has 60 days from the date of notification to make the GRASE determination.
- A public comment period of 45 days must be provided for proposed sunscreen orders or letters.
- Subsequently, the Act requires that the Secretary issue a Final Sunscreen Order not later than 90, 210, or 270 days depending on particular circumstances (including whether the proposed order identified the active ingredient as GRASE and not misbranded, is not GRASE and is misbranded, or is not GRASE and is misbranded because the data are insufficient to classify the ingredient as GRASE and the sponsor submitted additional information and the Advisory Commission is convened).
- If the Secretary does not issue a final sunscreen order within these 90-, 210-, or 270-day time period, the sponsor may notify the Office of the Commissioner and the Commissioner must issue a final sunscreen order within 60 calendar days after the date of notification.
- Allows the Secretary to amend a determination if additional information becomes available.
- (Sec. 3) Allows sponsors of eligible non-sunscreen OTC drug applications to request that the Secretary provide a framework for review of their application. Requires the Secretary to respond with framework options, including options that follow the review process set forth in this Act for sunscreen active ingredients.
- (Sec. 4) Directs the Comptroller General (GAO) to report on the progress of the Secretary in establishing this process and the role of the Commissioner in issuing determinations on pending requests. Requires the Secretary to report on the decisions made about the safety and efficacy of sunscreen active ingredients, the amount of time between submission and decision for each request, the cost of the review process, and recommended improvements to the review process.
Maybe a bit more detail regarding the time frames than necessary for a blog, but I provide these details for a reason. Under the existing regulatory system for sunscreens, the two-part process for classifying active ingredients under the OTC drug monograph system resulted in a backlog of ingredients that have been waiting for approval (some for more then a decade). This new mandatory time frame should result in the introduction of new ingredients and innovation by entities previously stymied by the lack of process.