While the Food and Drug Administration's expedited drug review results in faster approval, the drugs undergoing this type of review are tested less rigorously and are approved with more outstanding questions than drugs approved under normal review, according to research in the Journal of the American Medical Association.
Researchers examined the 20 therapeutic drugs the FDA approved in 2008, eight of which "were deemed sufficiently innovative to receive expedited review."
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Expedited drugs took a median of 5.1 years from development to market, 2.4 years less than the median for drugs under the standard process. During that time, standard drugs were tested on a median of 580 patients, while expedited drugs were tested on a median of just 104 patients.
In addition, among all drugs approved in 2008, the FDA issued 5 boxed warnings. By 2013, 5 drugs received new or expanded boxed warnings. Of the 85 postmarket studies the FDA ordered, only 31 percent had been completed by 2013 and only 9 percent had been sent to the FDA for review.
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