government
House panel endorses drug user fee reauthorization
NEWS IN BRIEF — Posted May 21, 2012
The House Energy and Commerce Committee on May 10 unanimously approved legislation (HR 5651) to reauthorize the Prescription Drug User Fee Act and the Medical Device User Fee Act, as well as authorize new user fee programs under the Generic Drug User Fee Act and Biosimilars User Fee Act.
The user fees are paid by drug manufacturers for expedited reviews of new drugs. The legislation would require the Food and Drug Administration to commit to certain performance goals with the aim of fostering more interaction, predictability and certainty between manufacturers and the agency. It includes reforms authors say are needed to ensure that patients receive quality care and timely access to new therapies, according to the committee.
“The FDA Reform Act contains important metrics that will hold the FDA accountable for its performance, will help provide new therapies to our nation’s children, significantly improve scientific exchange at FDA’s advisory committees, and ensure transparency and public input in the development of FDA’s guidance documents,” Rep. Fred Upton (R, Mich.), the panel’s chair, wrote in a statement. “Finally, it will help our nation’s patients, doctors, nurses and hospitals as they deal with drug shortages.”
The Senate Health, Education, Labor and Pensions Committee approved drug user fee reauthorization legislation on April 25. The approvals opened the door for full Senate and House considerations of the measures the week of May 14.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2012/05/21/gvbf0521.htm.
