H.R. 2430 reauthorizes Food and Drug Administration’s (FDA) critical medical product user fee programs, ensuring the agency has the tools it needs to more efficiently deliver safe and effective drugs, devices, and treatments to patients.
“We appreciate President Trump signing this critical reauthorization into law,” said Energy and Commerce Committee Chairman Greg Walden (R-OR), Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ), Health Subcommittee Chairman Michael C. Burgess, M.D. (R-TX), and Health Subcommittee Ranking Member Gene Green (D-TX). “This law will encourage new medical innovations, bring lower cost drugs to market faster, improve the regulatory review process for devices and treatments and, most importantly provide certainty to patients and the health industry. Paired with the implementation of the 21st Century Cures Act, this law continues to deliver much needed hope to patients everywhere.”
In April, bipartisan leaders of the Energy and Commerce Committee, along with bipartisan leaders of the Senate Health, Education, Labor and Pensions (HELP) Committee, released a discussion draft of the FDA Reauthorization Act of 2017, reauthorizing FDA’s user fee agreements. The draft followed a series of hearings examining the four individual user fee programs – the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA), the Prescription Drug User Fee Act (PDUFA), and the Medical Device User Fee Amendments (MDUFA). #SubHealth advanced H.R. 2430 by voice vote in May, and passed out of the full committee by a vote of 54-0 in June.