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Published on 26 October 2009

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FDA questioned over drug approvals


Drugs for cancer and other diseases have been allowed to remain on the market even after follow-up studies showed they did not extend patients’ lives, according to US investigators.

They report that the Food and Drug Administration (FDA) has never pulled a drug from the market due to a lack of required follow-up about its actual benefits, even when such information is more than 10 years overdue.

The investigators, for the Government Accountability Office (GAO), say the FDA should do more to determine whether drugs approved on the basis of preliminary trials actually provide the claimed benefits.

The FDA said that the “accelerated approval” programme is only used to approve drugs for the most serious diseases, and that “millions of patients with serious or life-threatening illnesses have had earlier access to new safe and effective treatments”.

An example, it said, is AstraZeneca’s lung cancer drug Iressa, which was approved in 2003 based on early results showing it reduced the size of tumours. Later studies showed it does not significantly extend patient lives.

The FDA has left the drug on the market, despite hundreds of reports of a sometimes fatal pneumonia. A spokesman said the agency has no plans to get more aggressive.

Copyright Press Association 2009

Food and Drug Administration


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