As readers of this blog may recall (see here), the purpose of the Sunscreen Innovation Act (SIA) was to speed up FDA’s review of time and extent applications (TEAs). TEA process provides a pathway for adding an active ingredient to an existing over-the-counter (OTC) drug monograph. Under the TEA program, instituted in 2002, FDA will consider accepting an active ingredient for inclusion in the OTC drug monograph even though the product was initially marketed in the United States only after May 1972. For active ingredients with marketing experience outside the United States, FDA requires proof that the product: (1) was marketed outside the United States as an ingredient in OTC drugs for purchase by consumers; and (2) was “marketed OTC for a minimum of five continuous years in the same country and in sufficient quantity” (although more than a single country may be appropriate depending on the extent of marketing). Twelve years after institution of the program, FDA had yet to act on any of the pending TEAs; some of which had been pending for almost a decade.
The SIA was intended to speed up the process of review of TEAs, setting specific timelines and deadlines for FDA to act. Although the focus was on sunscreen active ingredients, the SIA also included provisions to speed up FDA’s review of non-sunscreen active ingredients.
The SIA included a provision requiring that GAO issue a report on FDA’s implementation of the Act. At the end of November, about three years after the enactment of the SIA, GAO issued its report. The report addresses
- the extent to which FDA has complied with the SIA requirements;
- the status of FDA’s review of applications for sunscreen active ingredients; and, in an appendix to the report;
- the steps FDA has taken to review TEAs for non-sunscreen active ingredients.
Sadly there is little good news. FDA did all it was required to do under the SIA in a timely manner. It completed review of all TEAs for the sunscreen and non-sunscreen active ingredients. However, none of the active ingredients is any closer to being marketed in the United States, and consumers will not be seeing any innovative sunscreens on the market any time soon. For all TEAs for sunscreen active ingredients, FDA determined that additional safety data are needed before FDA can determine that (or whether) the ingredients are Generally Recognized as Safe and Effective (GRASE), which is the standard that must be met for the ingredients to be marketed in the United States without FDA’s premarket approval.
GAO reports that, at this time, none of the sponsors of the TEAs for sunscreen active ingredients have plans to provide the additional safety data; they are either still considering whether to conduct the required additional tests or they have determined not to do so. Reasons for their reluctance include return on investment and the requirement for animal tests. In addition, some sponsors have expressed concern that even if they were able and willing to generate the requested data, they were uncertain that the agency would not require more tests in the future.
For the non-sunscreen TEAs, the news is no better. In 2016, FDA determined that two non-sunscreen TEAs contained insufficient information to be filed for review. Three non-sunscreen TEAs were withdrawn in 2016, with representatives of the sponsors citing increased regulatory scrutiny of the active ingredient and the additional safety and effectiveness data requested by FDA as reasons for the withdrawal. As of November 2017, one TEA remains pending because the sponsor did not request a review framework. This TEA will be reviewed under the time frame established in FDA’s regulation issued in November 2016, i.e., in 2019.
Thus, despite Congress’s best intentions, the SIA will not result in increased availability of sunscreen active ingredients that have been available to consumers in other countries for more than a decade.