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Latta Highlights OTC Monograph Draft Legislation at E&C Health Subcommittee Hearing

Washington, September 13, 2017 | Drew Griffin (202-225-6405)
At an Energy & Commerce Health Subcommittee hearing, Congressman Bob Latta (R-Bowling Green) highlighted his recently released bipartisan draft legislation to reform the outdated over-the-counter (OTC) monograph system. The draft, the Over-the-Counter Monograph Safety, Innovation, and Reform Act, would modernize the monograph framework to allow the FDA to make scientific determinations for OTC ingredients through an administrative order process, an approach closer to new drug application procedures. The health hearing was entitled, “Modernizing FDA’s Regulation of Over-the-Counter Drugs,” and witnesses included health care advocates, industry professionals, and Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research at the Food and Drug Administration.

Latta remarked, “Over-the-counter medicines are in nearly every household across our nation; yet despite widespread utilization, the system in place to regulate these drugs has been outdated for decades. It’s time to move toward a more flexible framework that will spur innovation, expand consumer choice, and better address potential safety concerns. I believe the discussion draft before us today will achieve these goals and provide predictability to the drug approval process.”

Video of Latta’s statement is available here.

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