government
Senate panel OKs drug user fee reauthorization
NEWS IN BRIEF — Posted May 7, 2012
A Senate committee advanced legislation to reauthorize the Food and Drug Administration program that charges fees to expedite government reviews of drugs.
The Senate Health, Education, Labor & Pensions Committee approved the reauthorization bill by a voice vote on April 25. The legislation would continue programs that shorten the time medicines spend under federal review before being approved for use, while also increasing FDA penalties for adulterated drugs and giving the agency more tools to ensure a national supply of medications.
The American Medical Association strongly supports provisions addressing national drug shortages, the Association stated in an April 24 letter. The bill proposes revising the timing of advance notifications of possible shortages, requiring a strategic plan on shortages, broadening the definition of what constitutes a meaningful disruption of drug supplies, and creating a process for physicians and others to report evidence of shortages.
The bill also would provide incentives for manufacturers to produce the next generation of antibiotics and create a role for patients and health experts during the agency’s review of new treatments for rare diseases, which could lead to faster approvals.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2012/05/07/gvbf0507.htm.
