FDA Deadlines May Impact Drug Safety

By LAURAN NEERGAARD – 6 hours ago

Read entire article: http://ap.google.com/article/ALeqM5h...wHnBAD8VLBK6O0

WASHINGTON (AP) — Vioxx, Bextra, Rezulin, Baycol. Looking at drugs yanked off the market, Harvard researchers found a disturbing pattern: Medicines approved right on deadline by the Food and Drug Administration are more likely to cause safety problems later than those cleared with more time to spare.

Congress set strict deadlines for FDA to speed the arrival of new medications, but critics have long complained that the ticking clock spurred a dangerous rush to judgment.

The Harvard analysis of decades of drug approvals, published in Thursday's New England Journal of Medicine, provides the first scientific evidence supporting some of those complaints.

The FDA challenged the findings with its own statistics. Still, the study sparked calls to re-examine the balance between speed and safety.