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Study Questions FDA’s Shorter Drug Approval Times

Faster approvals may compromise safety (October 28)

The FDA has created fast-track approval processes to speed certain drugs to market, but an analysis of these expedited approvals finds that they often leave important safety questions unanswered. The analysis was published Oct. 28 in JAMA Internal Medicine.

To help expedite drug approvals, the FDA has created processes that waive some of the requirements that are part of a standard 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, of the Institute for Safe Medication Practices, and Curt Furberg, MD, PhD, of the Wake Forest School of Medicine, has found that although fast-track approvals may shave about 2.5 years off approval time, they also provide less information about the safety and efficacy of the drugs.

Moore and Furberg examined 20 drugs approved by the FDA in 2008, including eight that received expedited reviews and 12 that received standard reviews. They found that the expedited drugs took a median of 5.1 years of clinical development to obtain marketing approval, compared with a median of 7.5 years for the drugs undergoing standard approval (P = 0.05). But the expedited drugs were tested on far fewer patients — a median of 104 patients, compared with a median of 580 patients for the standard-review drugs (P = 0.003).

Safety problems emerged after approval for drugs in both categories. Nonclinical testing showed that six drugs were animal carcinogens, five were in vitro mutagens, and 14 were animal teratogens. Other safety concerns resulted in five boxed warnings, and eight drugs required risk-management plans. By 2013, five drugs acquired a new or expanded boxed warning.

According to the authors, many safety questions that might have been resolved by FDA postmarketing studies remain unanswered, as less than one-third of 85 such studies had been completed by 2013.

Sources: JAMA News; October 28, 2013; and JAMA Internal Medicine; October 28, 2013.

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