Medicines approved right on deadline by the Food and Drug Administration are more likely to cause safety problems

FDA Deadlines May Impact Drug Safety | By LAURAN NEERGAARD – 20 hours ago

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.
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"The article is a wake-up call," said Dr. Steven Nissen, the Cleveland Clinic's influential cardiology chief who helped sound the alarm on the risks of some of those ultimately doomed drugs

"It puts the FDA in a very difficult situation when they're trying to make complex decisions under these very, very tight deadlines," he added. "We've got to reevaluate now whether that's good public policy."
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"FDA staffers by their own admission feel very much under the gun as these deadlines loom," added Dr. Jerry Avorn of Brigham and Women's Hospital in Boston, who co-authored the study. "If they're forced to make decisions prematurely, they may not make the right decisions. That needs to be debated openly." ...