Fast Safety Trials Might Have FDA to Blame for Drug Recalls - KCBD NewsChannel 11 Lubbock

3/26/08

Fast Safety Trials Might Have FDA to Blame for Drug Recalls

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The Federal Drug Administration is under tremendous pressure to get life-saving drugs on the market. In 1992, congress set deadlines giving the FDA 12 months to review most new drug applications. It was later revised to 10 months, with a six-month deadline for drugs on the fast track.

Now, a Harvard study suggests that those deadlines are likely to blame for a lot of drug recalls.  Dr. Jerry Avorn, of Harvard Medical School, says, "These deadlines may be speeding up drug approvals. But we're paying the price later on with safety problems that were not anticipated when the decisions were made."

The Harvard study found that drugs approved just before the deadline were almost five times more likely to get a black-box safety warning and five times more likely to be pulled off the market later.

That same 1992 law requires drug companies to pay half of the FDA's budget for drug approvals. The FDA claims that the Harvard numbers are off- the agency says it did its own study and found no difference in problems with drugs approved before or near the deadline. 

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