Revised Study Maintains Link Between FDA Approvals Made Soon Before Deadlines, Safety Risks

Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Public Health;  Pharma Industry / Biotech Industry
Article Date: 04 Jul 2008 - 6:00 PDT

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Harvard University professor Daniel Carpenter has made revisions to a study published in March that found prescription drugs hurried through the FDA approval process are more likely to later be linked to safety risks, but he maintains that the study's conclusions are still accurate, the Wall Street Journal reports. In a letter published in the New England Journal of Medicine, Carpenter acknowledges mistakes FDA pointed out in the original study, also published in NEJM, but he says FDA's own records also contain errors.

According to the new numbers, between 1993 and 2005, 88 drugs approved near agency deadlines had a 15% chance of being flagged for severe safety problems -- either with a "black box" warning or a complete withdrawal -- compared with a 5% rate of safety problems for 226 other drugs. The March study showed that drugs approved near deadline had a 14% chance of safety problems, compared with 3% for other drugs.

Carpenter in a 151-page memo released online wrote, "I'll frankly admit that we omitted four or five of the black box warnings," but FDA also "missed a whole bunch of black box warnings." Carpenter also released his raw data online. An FDA spokesperson said the agency has not had a chance to review the revised analysis.

The Journal reports, "The findings suggest that the agency may have been under stress to meet deadlines imposed by agreements with the pharmaceutical industry since 1992." In exchange for "agreeing to quick approval of drug applications, FDA gained the legal authority to collect substantial fees from companies with business before the agency," the Journal reports. FDA promises to reach a decision on 90% of new drug applications within 10 months. Fees paid by drug makers account for about half of the $680 million the agency will spend on new drug reviews this year (Winstein, Wall Street Journal, 7/3).

Carpenter's letter and a letter from FDA economist Clark Nardinelli are available online.

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