Amidst the onslaught of regulatory and legislative announcements and changes occurring daily during this unprecedented time, a long-awaited (in some quarters) legislative change quietly and finally became law. On March 27, 2020, President Trump signed into law the CARES Act which includes an array of COVID-related provisions. CARES Act, Pub. L. 116-136 (2020). Buried in its many hundreds of pages are the OTC monograph reform provisions of the CARES Act which appear in Subtitle F. Congress did not name the law. Part I provisions address the reform of the review process and are added to the Food, Drug, and Cosmetic Act (FDC Act) in new section 505G. Subtitle F Part II covers the new OTC monograph user fee provisions adding sections 744L and 744M to the FDC Act.
Highlights of the amendment are a change from the much-maligned archaic rulemaking framework to an administrative order process, the abandonment of the concept of the unresolved regulatory status of drugs marketed under a tentative final monograph, or TFM, in favor of making a wholesale determination of active ingredients in categories I, II, and III, a mechanism for the issuance of an interim final order to address imminent safety issues, and provisions allowing innovation with a possibility of 18 months of marketing exclusivity. Finally, the legislation includes a user fee provision that allows for certain fees for OTC monograph drug manufacturing facilities and certain requests for changes to the monograph.
As has been the case with other user fee laws, industry and FDA agreed upon a Goals Letter that, among other things, describes how this vast overhaul will be implemented over the course of the first several years and timeline goals for many FDA actions.
Hyman, Phelps & McNamara, PC has prepared a summary memorandum that details these and other aspects of the OTC Monograph Reform and User Fees. It’s a whole new OTC monograph world out there!