The Senate easily passed a reauthorization of the Food and Drug Administration's drug and device user-fee programs and authorized new generic and biosimilar user-fee programs.
The 96-1 vote to pass the measure followed a series of close votes that crossed partisan lines in which the chamber rejected a series on amendments, including one to allow the importation of pharmaceuticals from Canada.
The vote moves Congress one important step closer to renewing the FDA program before it expires Sept. 30.
The program allows the agency to collect fees from the healthcare sectors it regulates in exchange for agreeing to meet certain performance goals related to timely consideration of their product marketing applications. Federal law requires reauthorization of the user-fee programs every five years.
The House Energy and Commerce Committee unanimously approved its similar version of the FDA bill
Health industry groups celebrated the Senate vote.
Chip Kahn, president and CEO of the Federation of American Hospitals, said in a written statement (PDF)
that the Senate-passed bill was a “significant step” toward addressing the nation's prescription drug shortages. “Increasingly, our hospitals are confronted by these shortages and challenged, without advance notice, to quickly procure supplies of vital prescription drugs that are indispensable for saving lives and providing quality patient care.”
The bill includes some steps to address such drug shortages.
“The user fee agreement reached between FDA and industry and implemented by this legislation is a potential game-changer that could help accelerate the development and approval of safe and effective treatments and diagnostics,” Stephen Ubl, president and CEO of the Advanced Medical Technology Association
, said in a written statement issued after the vote. “Through a combination of groundbreaking accountability and transparency measures and enhanced FDA resources, the user-fee agreement has the potential to increase the predictability, consistency and efficiency of FDA's decision-making, while maintaining the agency's stringent product approval standards.”