FDA doesn't act on post-marketing data

Remember that consultant's report that found drugmakers' post-marketing studies were usually on time and on track? Well, the Government Accountability Office has come to a different conclusion. The GAO says that some of those studies are years late and that the FDA doesn't flog companies for missing their deadlines. What's more, the completed studies don't trigger FDA action even when that action is warranted, the Associated Press reports.

According to the GAO document obtained by the AP, some drugs approved under the FDA's accelerated program fail to show clinical benefits once they're on the market. And not only has the agency never pulled a drug whose post-marketing numbers didn't pan out; it also doesn't even have a policy for doing so. Nor does it plan to develop one, Deputy Commissioner Joshua Sharfstein told the AP.

The GAO recommends that FDA set some standards for enforcing post-marketing requirements. And Commissioner Margaret Hamburg has pledged to boost enforcement now that she's in charge of the agency. Will that promise translate into action on this issue? We'll have to wait and see.

- read the AP news [1]

Related Articles:
FDA: Most post-marketing studies on time [2]
Post-marketing studies are the new norm [3]
Pharma drags feet on promised studies [4]