FDA: Most post-marketing studies on time

Good news on post-marketing safety studies. An FDA-commissioned analysis found that more drugmakers have completed the required post-approval tests than previously thought.

In fact, some 80 percent of those trials were either finished on time or were on schedule to be wrapped up by their deadlines, the study by Booz Allen Hamilton found. "Most companies are doing these studies and they are submitting the reports," said Dr. John Jenkins, director of the FDA's Office of New Drugs.

But the study found that more of the studies had been officially delayed--15 percent compared with the 6 percent originally estimated. And critics said that even the completed studies don't always offer useful information on safety or efficacy because the patients aren't always tracked as carefully as patients in pre-approval studies are.

Booz Allen came up with some recommendations for improving the FDA's post-marketing oversight. Nine suggestions in all, some of which the FDA has already put in place. Given that the backlog analysis is now required every year, we'll see in 12 months or so whether the improvements bear fruit.

- see the FDA release
- check out the story from the Post-Chronicle

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