Speaking Tuesday, May 21, at the Consumer Health Products Association Regulatory, Scientific, and Quality Conference, FDA Chief of Staff Lauren Silvis emphasized that over-the-counter (OTC) monograph reform remains a “top priority” for FDA.  Based on these comments, FDA is clearly not giving up on monograph reform:

FDA has long engaged in this effort, and we will continue to do so, working with all stakeholders and Congress to make clear that OTC monograph reform is a critical public health priority.  It’s in the best interest of patients to modernize the monograph system.  That means that FDA will continue to engage on this issue, until we have a system for OTC drugs that provides Americans what they need to better manage their own health care.  We know it’s up to Congress to legislate on this issue, but you’ll continue to hear from FDA that OTC modernization will help consumers take charge of their own healthcare, promote safety and innovation, and help Americans lead healthier lives.

FDA’s perseverance on OTC monograph reform is particularly important because on May 16, the Senate passed FDA’s pandemic preparedness reauthorization legislation, S. 1379, after stripping out the monograph reform bill that had been paired with it in the House-passed H.R. 269.  Now the Senate will need to take up the monograph reform bill separately, which could require a conference committee to iron out the differences or require the House to re-pass the monograph reform bill to match Senate action on the bill.

Silvis also stated that FDA is “pushing forward with” the advancement of the Nonprescription Safe Use Regulatory Expansion (NSURE) program that aims to help facilitate prescription (Rx) to nonprescription switches, as well as FDA’s issuance of a draft guidance titled “Innovative Approaches for Nonprescription Drug Products,” which (as we analyzed here) describes the agency’s thinking on switching Rx drugs to OTC in cases where the drug facts labeling alone is insufficient to ensure safety and efficacy in a nonprescription setting.  Significantly, Silvis said that FDA is “actively working on a proposed rule that will provide more information on this topic.”  We note that in the Spring 2019 Unified Agenda, FDA projected the proposed rule would be issued in December 2019.  Note, however, that this is the fourth time since 2017 that FDA has pushed back the target date published in the Unified Agenda for issuing the proposed rule.

We will continue to monitor the agency’s advancement of OTC monograph reform and keep you apprised of developments in the space.

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