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.