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FDA allows ineffective drugs to stay on the market for years, and says it has no intention of changing


I think "Department of all the Damn Gall" is an understatement.


The Food and Drug Administration has allowed drugs for cancer and other diseases to stay on the market even when follow-up studies showed they didn’t extend patients’ lives, say congressional investigators.

A report due out Monday from the Government Accountability Office also shows that the FDA has never pulled a drug off the market due to a lack of required follow-up about its actual benefits — even when such information is more than a decade overdue.

When pressed about that policy, agency officials said they have no plans to get more aggressive.

[...]Of the 144 studies the FDA has required under the program since 1992, 64 percent have been completed and more than one-third are still pending, according to the GAO. Investigators said the FDA does not rigorously track whether companies are making progress on their required studies, although the agency is improving.

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beowulf's picture
Submitted by beowulf on

Edward Shorter argues in Before Prozac (outstanding book, must read for anyone interested in psychiatry) and the journal article abstracted below that the FDA was once in the habit of booting effective drugs off the island pretty much to show the drug companies who was boss.

The liberal state and the rogue agency: FDA's regulation of drugs for mood disorders, 1950s-1970s
Authors: Edward Shorter

Journal: International Journal of Law and Psychiatry
The theory of the liberal state does not generally contemplate the possibility that regulatory agencies will turn into "rogues," regulating against the interests of their clients and, indeed, the public interest. In the years between circa 1955 and 1975 this seems to have happened to one of the prime regulatory agencies of the US federal government: the Food and Drug Administration (FDA). Intent upon transforming itself from a traditional "cop" agency to a regulatory giant, the FDA campaigned systematically to bring down some safe and effective drugs. This article concentrates on hearings in the area of psychopharmacology regarding several antianxiety drugs, namely meprobamate (Miltown), chlordiazepoxide (Librium) and diazepam (Valium). In addition, from 1967 to 1973 this regulatory vengefulness occurred on a broad scale in the Drug Efficacy Study Implementation (DESI), an administrative exercise that removed from the market almost half of the psychopharmacopoeia. The article explores possible bureaucratic motives for these actions.
International journal of law and psychiatry. 31(2):126-35.