Safety Questions Remain About FDA's Expedited Review of New Drugs
Expedited Review Speeds Approval of New Drugs by FDA
(HealthDay News) -- In 2008, new drugs that received expedited review by the U.S. Food and Drug Administration were approved more rapidly, but many questions about safety remain unresolved, according to research published online Oct. 28 in JAMA Internal Medicine.
Thomas J. Moore, A.B., of George Washington University in Washington, D.C., and Curt D. Furberg, M.D., Ph.D., of the Wake Forest School of Medicine in Winston-Salem, N.C., examined the approval process and safety risks for new drugs approved in 2008.
The researchers found that 20 therapeutic drugs were approved, eight of which received expedited review. The approval process for drugs receiving expedited review differed significantly from that of drugs receiving standard review in median time to receipt of marketing approval (5.1 and 7.5 years, respectively) and median number of patients receiving the active drug in studies of efficacy (104 and 580 patients, respectively). The FDA required 85 post-market commitments for the 20 drugs; by 2013, 31% of these had been fulfilled.
"If the FDA's requirements for new drugs, both premarket and post-market, are weakened, trust in both the efficacy and safety of prescription drugs is likely to be weakened," writes the author of an accompanying editorial.