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FDA doesn't act on post-marketing data

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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

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

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Drug companies are supposed to give the FDA all data on a given proposed new drug, but often omit data that suggests that the drug might be dangerous. It is only after people die that the lie of omission is discovered, and punative damages in subsequent lawsuits mount. But the awarded damages, even with punative damages, does not come close to the profit earned from the sale of the drug. So, there is no incentive to stop hiding information from the FDA. If a murderer writes a book on the crimes he has committed the laws on felonies prevents him from profiting from the sale of that book. Why should pharmaceutical companies be allowed to profit from the sale of a drug where the data on that drug was intentionally hidden from the FDA that is supposed to rubber stamp their safety guarentee on the product? The FDA needs bigger teeth, the drug companies should be made to give up every dime they earn on a drug they lied about-including any interest earned on that money- and ONLY sell products that they have been 100% forthcoming with. If it can be shown that the company new of a danger ahead of the FDA and didn't tell them shut them down.

All data is presented to the FDA and the reviewers at the Advisory Committee Meetings and is reviewed by the FDA! For every pharmaceutical company causing trouble for the FDA there are thousands of doctors milking Medicare & Medicaid that are never investigated or prosecuted. All of you do it and the fraud is so rampant that only the huge ones are ever gone after. Why do you think that the FDA was so fast at endorsing every scheme that had someone else paying for someone's healthcare! The ole ponzi trick, when someone else pays it's not really your money, now it is and we're all screwed! But wasn't it always our money. Nothing is ever free for anyone! The FDA has teeth but never uses them! Punish Pfizer for Neurontin and let managed care substitute it in neuro pain for the branded agent, Neurontin generic still has no indication! You figure!

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