On March 25 and 26, FDA’s Center for Drug Evaluation and Research (CDER) held a public hearing to obtain input on the over-the-counter (OTC) drug review process. Under the OTC Drug Review, FDA was able to determine, by therapeutic category, that thousands of OTC drug products were generally recognized as safe and effective (GRAS/E). FDA has issued final monographs for the majority of the original drug categories (codified at 21 CFR parts 331 to 361), with final rules that cover large segments of the OTC marketplace. Examples include fluoride toothpastes, acne products, and topical antifungals. Yet several remain unfinished while others need to be updated to reflect changes in science. FDA “is interested in exploring ways to re-engineer the process of regulating OTC drugs that are currently regulated under the OTC Monograph Process to, among other things, create a process that is more efficient and more responsive to newly emerging information and evolving science, and to allow for more rapid product innovation where appropriate.”
The hearing comes at a time of frustration with the monograph process and, in particular, the lack of clarity from FDA regarding its position on novel modes of delivery for active ingredients, or approval for the use of new ingredients in monograph products that have safely been used in other countries for years. FDA also has yet to finalize monographs for several product categories, which cover thousands of products that are currently marketed under pending tentative final monographs. According to FDA, part of the stagnation in the process is due to FDA’s regulations, which impose a “lengthy” notice and comment rulemaking process, including the publication of an Advanced Notice of Proposed Rulemaking, a Tentative Final Monograph, and a Final Monograph that establishes conditions under which an OTC drug is considered generally recognized as safe and effective and can be marketed.
According to FDA’s Federal Register Notice, FDA seeks comments on the strengths and weaknesses of the existing OTC review process, modernization concepts, and modification of or alternatives to the existing OTC review process. FDA apparently believes that the biggest challenges of the current system are:
- the large number of products marketed under the OTC Drug Review for which there are not yet final monographs,
- limitations on FDA’s ability to require, for example, new warnings or other labeling changes to address emerging safety or effectiveness issues for products marketed under the OTC Drug Review in a timely and effective manner, and
- the inability of the OTC Drug Review to easily accommodate innovative changes to products regulated under the OTC Drug Review.
However, the agency also requests comments that would identify any other scientific or regulatory challenges that are not listed in its notice. The March 25 and 26 hearing regarding the OTC Drug Review included testimony from trade associations, industry, outside counsel, doctors, and pharmacists, who, while in disagreement about the causes of the stagnation and ideal future for the review, nevertheless, stressed their desire for FDA to prioritize and complete the monograph review process. FDA action in this area will greatly impact the consumer health and personal care products industries, which manufacture and sell hundreds of thousands products based on tentative and final OTC drug monographs.
FDA is accepting comments until May 12, and plans to release a transcript of the hearing by April 25. More information regarding the request for comment is available here.