Congress Passes the Sunscreen Innovation Act to Speed up FDA’s Review of Time and Extent Applications for Sunscreen Ingredients and Other OTC IngredientsNovember 25, 2014
By Riëtte van Laack –
The House of Representatives on Nov. 13 unanimously passed the Senate version of the Sunscreen Innovation Act (SIA), S. 2141. The Act is currently before the President, who is expected to sign it. The SIA amends the Food, Drug, and Cosmetic Act to provide specific deadlines for FDA’s review of time and extent applications (TEAs) for sunscreen ingredients and to require FDA to set specific deadlines for review of TEAs for non-sunscreen ingredients. For background information on TEAs, see our previous post here.
The SIA details timelines for FDA review of currently pending TEAs for sunscreen ingredients as well as for review of new TEAs submitted after enactment of the law. Eight sunscreen TEAs have been under FDA review, with some pending for more than a decade. In 2014, FDA stepped up its review efforts and issued response letters for five of the TEA applications. Under the SIA, these five response letters are “deemed to be . . . proposed sunscreen order[s] and [must] be displayed” on FDA’s website and “announced” in the Federal Register within 45 days of enactment of the SIA. The pending TEAs which have not yet been reviewed must be reviewed and a proposed order for each must be published within 90 days of enactment of the SIA. The table below shows the timing for these pending TEAs. If FDA makes a determination that the substance is generally recognized as safe and effective (GRASE) or not GRASE based on sufficient data, the timing is predictable; a final order must be issued 135 days after publication of the proposed order. However, there is a risk of “slippage,” in those cases where FDA determines that “data are insufficient to classify as GRASE” and additional information is necessary to allow a determination as to the status of the ingredient.
Outline of timing for new sunscreen TEAs pending
45 days after SIA becomes law for TEAs with response letter before SIA.
90 days after SIA becomes law for TEAs without response.
Sponsor may request meeting within 30 days after proposed order. FDA must grant meeting within 45 days after date of meeting
FDA may convene advisory committee (adcom).
90 days after closing of comment period, if sufficient data to determine GRASE/not GRASE.
210/270 days after receipt of data from sponsor, if insufficient data to make determination if GRASE; 210 days if no adcom convened, 270 days if adcom convened.
For new sunscreen TEAs, the SIA also sets specific timelines for FDA’s determination whether a sunscreen TEA is eligible for review and FDA’s substantive review of the TEA. The outline below shows the timing for such new TEAs. Although there are specific deadlines for FDA review, etc., there is a possibility for slippage in the determination of the eligibility and in instances where FDA determines that additional information is necessary to allow a determination whether the ingredient is GRASE.
Outline of timing for new sunscreen TEAs submitted after the enactment of SIA
Eligibility Determination/Filing of Request:
Within 60 days after sponsor’s submission of data in support of GRASE determination, FDA must determine whether data are sufficient to file request.
FDA Refuses Filing of Request:
Within 60 days after sponsor’s submission data, FDA refuses filing. Sponsor can request meeting within 30 days of refusal.
Data Submission for Filed Request:
FDA will provide no less than 45 days for comments related to TEA that has been found eligible.
Publication Proposed Order:
Within 300 days after request is filed.
FDA may convene adcom during these 300 days.
Sponsor may request meeting within 30 days after proposed order; FDA must grant meeting within 45 days after date of meeting request.
90 days after closing comment period, if sufficient data to determine GRASE/not GRASE.
210 days after receipt data from sponsor, if FDA determined that data were insufficient to make determination if GRASE.
Once FDA has issued a final order that the sunscreen ingredient is GRASE, it may be marketed. At a later time, but within 5 years after the enactment of the SIA, FDA may amend the sunscreen monograph to include the new active ingredients subject to final orders. (Once included in the final monograph, the final order for the sunscreen ingredient will cease to be effective).
Whether the SIA will in fact result in more sunscreen ingredients being available remains to be seen. The SIA sets deadlines for FDA’s review. However, it does not require that FDA find the ingredients to be GRASE.
Although named “Sunscreen Innovation Act,” the act also addresses TEA reviews for ingredients that do not fall under the sunscreen monograph. For TEA applications for non-sunscreen active ingredients, the act requires that FDA issue proposed regulations with timelines for TEA reviews within 18 months after the SIA has been signed into law. Sponsors of pending non-screen ingredient TEAs that have already been found eligible for evaluation of inclusion in the relevant monograph can ask FDA to provide a review framework for their TEAs rather than wait until FDA issues the regulations. Such requests must be made within 180 days of enactment of the SIA. FDA’s timelines “may vary based on the content, complexity, and format of the application” and must reflect public health priorities and “take into consideration[,] the resources available to [FDA].” In light of the requirements for sunscreen ingredients and FDA’s other obligations (e.g., finalizing the monograph for antimicrobial substances), it may well be years before these TEAs will be reviewed.