Author Insights: Rapid Drug Approvals Leave Many Safety Questions Unanswered

 news@JAMA

"The US Food and Drug Administration (FDA) has created fast-track approval processes to speed certain drugs to market, but an analysis of these expedited approvals finds they often leave important safety questions unanswered. The analysis was published today in JAMA Internal Medicine.
To help expedite approval of drugs, the FDA has created processes that waive some of the requirements that are part of a standard drug approval. These expedited reviews, popular with industry and patient groups, are used for drugs that the FDA determines represent “a significant therapeutic advance” or that fill unmet needs. The Obama administration has also proposed additional ways to speed the pace of drug approval.
But an analysis of the differences between standard and fast-track reviews by Thomas J. Moore, AB, a senior scientist at the Institute for Safe Medication Practices (ISMP) in Alexandria, Virginia, and Curt Furberg, MD, PhD, of the Wake Forest School of Medicine in Winston-Salem, North Carolina, found that although fast-track approvals may shave about 2½ years off approval time, they also provide less information about the safety and efficacy of the drugs.....


 analysis

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Original Investigation | October 28, 2013

"Development Times, Clinical Testing, Postmarket Follow-up, and Safety Risks for the New Drugs Approved by the US Food and Drug Administration"

 Conclusions and Relevance  For new drugs approved by the FDA in 2008, those that received expedited review were approved more rapidly than those that received standard review. However, considerably fewer patients were studied prior to approval, and many safety questions remained unanswered. By 2013, many postmarketing studies had not been completed.