Senate, House Health Committee Leaders Release Discussion Draft of FDA Animal Drug User Fees Reauthorization
WASHINGTON, February 8 — The leaders of the Senate and House health committees today released a discussion draft of bipartisan legislation reauthorizing the Food and Drug Administration’s (FDA) animal drug and generic animal drug user fee agreements.
The Animal Drug User Fee Reauthorization Act of 2018 renews FDA's authority to collect user fees from the makers of new animal drugs and generic new animal drugs. The 2013 animal drug user fee amendments (ADUFA) and generic animal drug user fee amendments (AGDUFA) must be reauthorized and updated by Congress to reflect the new commitments between FDA and industry before the current user fee agreements expire on September 30, 2018.
Senate health committee Chairman Lamar Alexander (R-Tenn.) said: “A timely reauthorization of these updated agreements will help speed safe and effective new animal drugs to farmers and ranchers, veterinarians, families, and animal food and feed producers to keep their animals healthy. It is important that Congress do its job and reauthorize these critical programs by late summer to ensure FDA can continue its work to review new animal drugs. These agreements are essential to ensure that animal drugs on the market are safe and effective for farm animals and pets, and help keep our food supply safe.”
Senate health committee Ranking Member Patty Murray (D-Wash.) said: “Congress has a bipartisan record of addressing FDA’s regulation of animal drugs in order to give veterinarians the treatments they need to keep our pets and food-producing animals healthy. I’m committed to building on that record this year by working with my colleagues to reauthorize the animal drug and animal generic drug user fees agreements to protect our food, our families, and our pets.”
House Energy and Commerce Committee Chairman Greg Walden (R-OR) said: “Following our reauthorization of several user fee programs over the summer, it’s critical we work to reauthorize these two, updated agreements. The Energy and Commerce Committee is dedicated to reauthorizing the animal drug user fees before the September 30th deadline to ensure that FDA’s Center for Veterinary Medicine can continue doing its work to review and approve safe and effective medical products. From our pets at home to farmers on their ranches, these agreements are vital tools in ensuring access to safe and innovative medication.”
Energy and Commerce Ranking Member Frank Pallone, Jr. (D-NJ) said: “These bipartisan proposals will ensure a timely reauthorization of ADUFA and AGDUFA, which are critically important to ensuring veterinarians, ranchers, farmers, and pet owners have access to safe, effective, and affordable medications for their animals. I commend my colleagues, our partners at FDA, and industry for their work on these important bipartisan agreements.”
The FDA Animal Drug User Fee Reauthorization Act:
- Updates and reauthorizes the animal drug and generic animal drug user fee programs, which supported 35 percent of pioneer animal drug reviews and 60 percent of generic new animal drug reviews.
- The final agreements reflected in this legislation were negotiated between the Food and Drug Administration and animal drug industries with input from farmers and ranchers, veterinarians, food and feed producers, and other stakeholders.
- Animal Drug and Animal Generic Drug User Fees Agreements between the Food and Drug Administration and the animal drug industries help to speed the development and approval of safe and effective new animal drugs to farmers and ranchers, families, and veterinarians to keep their animals and pets healthy, and our food supply safe.
Click here for the text of the discussion draft, and here for a section by section summary.
The Committee request comments on the legislation by interested stakeholders by February 12th at AgDUFA2018@help.senate.gov
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