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FDA Exercising New Caution in Approving Drugs

Written by on Tuesday, August 21st, 2007

The Food and Drug Administration ("FDA") is exercising new caution in approving drugs in the wake of the Merck Vioxx scandal, according to an Associated Press Report published on

The Associated Press Report stated as follows: 

The agency has approved 61 percent of drug applications through mid-August, down from 73 percent in the same period last year, according to BioMedTracker, a biotech and pharmaceutical research service. . . .

James Kumpel at Friedman, Billings, Ramsey & Co. just published a report showing FDA approvals of "new molecular entities" — drugs made from new chemical compounds rather then just twists on existing drugs — so far this year are at their lowest level in at least a decade. Only seven were approved through the end of July, versus an average of 12 over the first seven months of each year since 1998.

What are some of the specific examples cited by the article of the FDA’s caution?

  • Rejection of Merck’s Arcoxia, a successor to Vioxx;
  • Asking for more time to review its approved migraine drug Frova for a new use, preventing menstrual migraines;
  • Rejecting or delaying for approval Novartis’ diabetes drug Galvus, Sanofi-Aventis’ weight-loss drug Zimulti, and a higher dose of GlaxoSmithKline’s Advair Diskus for bronchitis and emphysema symptoms; and
  • Rejecting Wyeth’s experimental schizophrenia drug bifeprunox and Wyeth’s Pristiq, which would have been the first nonhormonal drug for menopause symptoms.

It was almost inevitable that the FDA would tighten up its practices and exercise more caution in approving drugs following all the bad publicity over the Vioxx scandal.  In some ways, this was perhaps warranted.  However, the question now is: are they taking caution too far?  Are they delaying good medicines from going to market that could be saving lives, in the exercise of extreme caution?  Only time will tell, and I am sure many in the biotech industry will be closely watching.







Category: Biotech Legislative Developments  |  Comments Off on FDA Exercising New Caution in Approving Drugs

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