#SubHealth Examines Draft Legislation to Create FDA User Fee Program for Over-the-Counter Drugs

Press Release

The Subcommittee on Health, chaired by Rep. Michael C. Burgess, M.D. (R-TX), today held a hearing examining draft legislation to establish an over-the-counter (OTC) monograph user fee program at the Food and Drug Administration (FDA).

#SubHealth reviewed draft legislation, the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2017, authored by representatives Bob Latta (R-OR), Diana DeGette (D-CO), Chairman Burgess, Vice Chairman Brett Guthrie (R-KY), and Ranking Member Gene Green (D-TX).

"This bipartisan proposal establishes the OTC Monograph User Fee Program and makes a number of meaningful modifications to the monograph process," stated Chairman Burgess. "The goal is to create a system that is more flexible and more efficient, and reflects the scientific innovations so that patients and consumers have greater access to better and safer OTC drug products."

Speaking to the need for the creation of the new user fee program, Energy and Commerce Committee Chairman Greg Walden (R-OR) stated, "…the regulatory process in place at FDA has not been updated since the 1970s. As a result, there has been little to no innovation in this sector, and safety-related changes often take years to implement. That is simply unacceptable. Fortunately, FDA, regulated industry, and patient and consumer groups all agree that significant reform is necessary."

Dr. Janet Woodcock, Director of FDA's Center for Drug Evaluation and Research, highlighted the successful Prescription Drug User Fee Act (PDUFA) and its subsequent reauthorizations, saying, "Following the success of PDUFA, Congress enacted additional user fee agreements (UFAs), such as those that cover medical devices, generic drugs, and biosimilar drug products, as well as animal drug products and generic animal drug products. …New legislation is needed to allow FDA to establish a similar program for OTC monograph drug products that will help ensure a better resourced and more streamlined, efficient process."

Mr. Scott Melville, President and CEO of the Consumer Healthcare Products Association (CHPA), highlighted the value of OTC medications beyond the price tag, saying, "The availability of OTC medicines, off-the-shelf, without a prescription, provides symptomatic relief for an estimated 240 million people, 60 million of whom would not seek treatment if OTC medicines were not available. OTC medicines also contribute to increased economic productivity due to less time out of work for physician visits or to care for a sick child."

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