U.S. Senator Bill Cassidy, chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, addressed a hearing on the reauthorization of the Over-the-Counter Monograph Drug User Fee Program (OMUFA).
Cassidy emphasized the importance of over-the-counter (OTC) drugs in American healthcare. "Over-the-Counter drugs are part of the fabric of Americans maintaining their health," he stated. He noted that these medications save an estimated $146 billion annually by reducing doctor visits and prescription purchases.
The senator highlighted past challenges with OTC drug approval due to lengthy review processes. "For decades, OTC drugs were required to go through a cumbersome review before going onto the market," Cassidy said. The creation of OMUFA in 2020 aimed to streamline FDA reviews while ensuring safety.
With OMUFA set to expire at the end of this fiscal year, Cassidy underscored the importance of evaluating improvements for better service. "This is why today’s hearing is so important," he remarked.
Cassidy acknowledged progress since 2020 but pointed out ongoing issues like regulatory hurdles preventing prescription drugs from being sold OTC and delays in reviewing new sunscreens. "FDA has failed to ease regulatory hurdles that allow prescription drugs to be sold OTC," he said.
Comparing U.S. sunscreen approvals with those in Europe and Asia, Cassidy noted that peer countries have more high-quality products available. He urged improvement from the FDA regarding sunscreen approvals.
In conclusion, Cassidy expressed eagerness for discussions on enhancing OMUFA and improving OTC review processes.
Senator Sanders was then recognized for his opening statement.
