Legislation Will Strengthen Review of Animal Drug, Animal Generic Drug, and Over-the-Counter Health Care Products

Press Release

The House of Representatives today passed two bipartisan Energy and Commerce Committee bills pertaining to user fee programs at the Food and Drug Administration (FDA).

Passing the House today was:

H.R. 5333, the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018, authored by #SubDCCP Chairman Bob Latta (R-OH), #SubOversight Ranking Member Diana DeGette (D-CO), #SubHeatlh Chairman Michael C. Burgess, M.D. (R-TX), #SubHealth Vice Chairman Brett Guthrie (R-KY), #SubHealth Ranking Member Gene Green (D-TX), and Rep. Debbie Dingell (D-MI). H.R. 5333 passed the House by voice vote.

H.R. 5333 will modernize regulation of over-the-counter (OTC) consumer health products, and establish a user fee program at the FDA for these products to ensure patients have timely access to new therapies. The bill passed the Energy and Commerce Committee in May 2018, by voice vote.
H.R. 5554, the Animal Drug and Animal Generic Drug User Fee Amendments of 2018, authored by Reps. Markwayne Mullin (R-OK) and Kurt Schrader (D-OR). H.R. 5554 passed the House by voice vote.

H.R. 5554 will amend the Federal Food, Drug, and Cosmetic Act to reauthorize user fee programs relating to new animal drugs (Animal Drug User Fee Act or ADUFA) and new generic animal drugs (Animal Generic Drug User Fee Act or AGDUFA). The bill passed the Energy and Commerce Committee in May 2018, by voice vote.
"From ensuring a timely reauthorization of the animal drug and animal generic drug user fees to modernizing how we regulate over-the-counter drugs, these are important victories for advancing our public health," said Energy and Commerce Committee Chairman Greg Walden (R-OR) and #SubHealth Chairman Michael C. Burgess, M.D. (R-TX). "We urge the Senate to swiftly follow our efforts, particularly on H.R. 5554, so that these programs are reauthorized ahead of the October deadline."

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