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US Senate passes FDA Reauthorization Act of 2017
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The United States Senate passed the FDA Reauthorization Act of 2017 (H.R. 2430) with a vote of 94-1.
“The Senate has sent to the president’s desk legislation that will speed cures and treatments into patient’s medicine cabinets,” Lamar Alexander (R-Tenn.) said in a press release. “The first step was last year’s passage of 21st Century Cures to spur medical research, and this is the next step — ensuring patients see the benefits of those research advancements.”
The FDA Reauthorization Act of 2017 will allow the FDA to accept user fees, which are paid by manufacturers of drugs and medical devices, that account for $8 billion to $9 billion during a period of 5 years. The bill includes the Generic Drug User Fee Amendments, the Biosimilar User Fee Act, the Prescription Drug User Fee Act and the Medical Device User Fee Amendments, which must be reauthorized by Sept. 30.
“Passing this bill is a crucial step in reauthorizing four user fee programs that ensure the Food and Drug Administration (FDA) has the tools it needs to deliver safe and effective treatments and cures to people with chronic diseases and disabilities,” Marc Boutin, chief executive officer of the National Health Council, said in a press release. “The new user fee programs will also include many patient-supported improvements, such as increasing the voice of the patient in product development, increasing transparency of biomarkers and surrogate endpoints, developing a process for using real-world evidence and improving the rare disease program.”
A discussion draft of the FDA Reauthorization Act of 2017 was released in April by bipartisan leaders of the Energy and Commerce Committee and bipartisan leaders of the Senate Health, Education, Labor and Pensions Committee. The draft was followed by a series of hearings that examined the four, individual user fee programs before being advanced through a voice vote in May and passed out of the full committee by a vote of 54-0 in June. The U.S. House of Representatives passed the legislation by a voice vote on July 12.
References:
www.alexander.senate.gov/public/index.cfm/pressreleases?ID=27CD0FC0-F27E-4A40-AD0D-64D823DBE11C