Do deadlines have any affect on how the FDA approves drugs...Harvard study says it can, FDA says not...but think...what happens when you are in a hurry to finish a you rush through things that normally you might dedicate a little more time for?  Yes?  No?  Will be interesting to see some additional trending and statistics...BD 

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

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.

Rush decisions by FDA may subvert drug safety - Health care-


Post a Comment

Google Analytics Alternative