WASHINGTON – U.S. Senator Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, delivered remarks during today’s hearing on the reauthorization of the Over-the-Counter Monograph Drug User Fee Program.
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Cassidy’s speech as prepared for delivery can be found below:
The Senate Committee on Health, Education, Labor and Pensions will please come to order.
Over-the-Counter (OTC) drugs are part of the fabric of Americans maintaining their health; treating common ailments, including pain relief, allergies, and cold symptoms at an affordable cost. They are available at every pharmacy and virtually every grocery store nationwide.
Being readily available to Americans, OTC drugs also save Americans a lot of money. These drugs generate an estimated $146 billion in annual savings from fewer doctors’ visits and prescription drug purchases.
For decades, OTC drugs were required to go through a cumbersome review before going onto the market. This process, known as a drug monograph, typically took years to finalize; many new OTC drugs were never fully approved. The review also made it more difficult for the Food and Drug Administration (FDA) to update safety information on OTC drugs, sometimes delaying safety recommendations for several years.
As a result of these challenges, Congress created the bipartisan Over-the-Counter Monograph Drug User Fee Program (OMUFA) in 2020 to streamline FDA review of OTC drugs; making these drugs more quickly available to Americans while still ensuring safety.
OMUFA is set to expire at the end of this fiscal year. As Congress looks to reauthorize, we must see how we can further improve the program to better serve Americans. This is why today’s hearing is so important.
I highlight that today is the first time Congress will be hearing directly from FDA about how they’ve implemented reforms to OTC drug review and their plans to make more low-cost drugs directly available to Americans. I appreciate FDA coming before the Committee.
While FDA has made progress in improving the OTC review pathways since 2020, there is still more to do.
FDA has failed to ease regulatory hurdles that allow prescription drugs to be sold OTC. These delays make it harder for consumers to directly access low-cost treatments.
The agency continues to struggle with reviewing new sunscreens. Despite the well documented public health value of using sunscreen, FDA has not approved a new sunscreen filter since 1999.
In contrast, peer countries in Europe and Asia have many more high-quality sunscreen products available to consumers. The FDA needs to do a better job with sunscreen.
I look forward to discussing how Congress can improve OMUFA and the OTC review process.
With that, I recognize Senator Sanders for his opening statement.
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