BMJ  2006;332:1350 (10 June), doi:10.1136/bmj.332.7554.1350-b

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FDA regulations make it harder to sue drug companies

Quebec

The US Food and Drug Administration has added a preamble to its new regulations that will make it difficult for anyone to bring legal action against a drug manufacturer for harm caused by one of its products, says an article in this week's edition of the New England Journal of Medicine (2006; 354: 2409-11[Free Full Text]). The new regulations, which have attracted little publicity, come into effect on 30 June.

Along with modest alterations to drug labelling to be phased in over the next seven years, the FDA's changes include "a regulatory time bomb" that could limit the accountability of companies that fail to adequately evaluate or report risks associated with their products, the article says.

The FDA describes the new labeling rules as a "breakthrough that will simplify the prescribing process for physicians, decrease medication errors, and improve patient safety."

The troubling aspect of the FDA's new plan, however, has nothing to do with providing information to prescribers, says the article.

"Beginning at the end of this month, the new regulations would pre-empt nearly all action by patients in state courts against drug manufacturers for unanticipated injuries resulting from the use of their products. This immunity would apply even if a company failed to warn prescribers or patients adequately about a known risk, unless a patient could prove that the company intentionally committed fraud—a very hard test to meet," it says.

The article quotes a former general counsel for the FDA as saying that regulations "will make it impossible to file liability claims."

Sidney Wolfe, director of Public Citizen, a public interest watchdog organisation, called the FDA's move "unfortunate and totally inappropriate" and done at the behest of drug companies "that want desperately to get the FDA to protect them from litigation."

Mr Wolfe said that the offensive new section is not part of the regulations themselves but is in the preamble and therefore not legally binding. "It just reflects the extent to which the FDA will bend over backwards to try and protect the industry... It's a very sneaky kind of thing. They [the FDA] could not legally put this in the regulation." But if a judge decides to take seriously what the preamble says it could be a disaster for patients, he said.

The authors of the New England Journal of Medicine article are Jerry Avorn, a professor of medicine at Harvard Medical School and William Shrank, an instructor at the same institution.

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