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Wednesday, October 30, 2013

How Safe Are Expedited Drug Approvals?

In order to advance biomedical research and innovation, the US Food and Drug Administration (FDA) has protocols for expedited drug approvals with shorter, smaller, and more selective clinical trials and less rigorous end points. But what does expedited approval mean for patient safety? A new study in the Journal of the American Medical Association Internal Medicine set out to examine the development times, clinical testing, postmarket follow-up, and safety risks of all drugs approved by the FDA in 2008 — by both standard and expedited review. Study authors Thomas Moore of the Institute for Safe Medication Practices and Curt Furberg, MD, a professor at Wake Forest School of Medicine, found that, in those drugs which received expedited review, many safety questions remained unanswered.

     The investigators compared the 20 therapeutic drugs approved by the FDA in 2008 — eight with expedited review and 12 with standard review. The list included tetrabenazine for Huntington's chorea and rufinamide for seizures in Lennox-Gastaut syndrome. They found that the expedited drugs took a median of 5.1 years of clinical development to obtain marketing approval compared with 7.5 years for the standard review drugs (P = .05). Expedited therapies were tested, on average, in 104 patients, whereas standard review drugs were tested in about 580 patients (P=.003).

     In the expedited approvals, the authors wrote, many safety questions lingered. Eight years later, many of the postmarketing studies had not been completed, indicating that patients may have been exposed to safety risks that were not well recognized, according to the paper.

     “The testing of new drugs has shifted from a situation in which most testing was conducted prior to initial approval to a situation in which many innovative drugs are more rapidly approved after a small trial in a narrower patient population, with extensive additional testing conducted after approval,” wrote Moore and Dr. Furberg. “Further systematic assessment of the standards and procedures for testing new drugs is needed.”

      See our previous coverage of drug safety risks: Stay tuned for a full discussion of these findings in an upcoming issue of Neurology Today.