02 February 2007

Drug makers slacking off?

Drug makers have failed to begin more than 70% of promised studies on products already approved for market, according to US government figures.

Drug makers have failed to begin more than 70 percent of promised studies on products already approved for market, according to US government numbers released Thursday, and a watchdog group is sick of it.

The US Food and Drug Administration report shows that 899 - or 71 percent - of the 1 259 post-market studies committed to by drug makers had not been started as of September 30, 2006. That's a 5 percent increase over last year, when the agency reported 65 percent of 1 231 promised studies were still pending, Bloomberg News reported Thursday. The report also found that only 185 - or 15 percent -of studies were ongoing, 31 were delayed, and 144 were submitted.

"How can the FDA claim it is committed to improving drug safety when it can't even get drug makers to do the studies they promise?" said Bill Vaughan, senior policy analyst with Consumers Union. "Should consumers really feel safe when two out of three studies aren't being done, and the FDA doesn't even have the authority to get them done?"

While the FDA has no authority under law to require those studies be performed, it approves some drugs with outstanding safety concerns on the promise that the maker will conduct post-market studies to determine if the medication causes any side effects. – (HealthDayNews)

Read more:
Research Centre
Bias in industry studies

February 2007

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