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New preamble to FDA regulations makes it harder to sue drug companies


David Spurgeon

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 maker 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). 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 severely limit the accountability of companies that fail to adequately evaluate or report risks associated with their products, the article says.

The labelling changes apply to the inserts included in drug packaging that give lengthy lists of drugs’ indications, effects, and associated risks, which the article says are "notoriously user-hostile" and are often discarded by pharmacists before the drugs are dispensed to patients.

The article says, "The labeling also constitutes the formal, government-approved definition of a drug’s benefits and risks … written by (and is the property of) the manufacturer but requires FDA approval, and it defines the boundaries of the legal promotion of a product’s properties."

The FDA has now admitted what most clinicians have known for decades, says the article. Current labelling is poorly organised, stuffed with often irrelevant information, and often fails to distinguish between a drug’s side effects and problems that may not even be causally related to its use.

The FDA describes the new rules as a "breakthrough that will simplify the prescribing process for physicians, decrease medication errors, and improve patient safety." However, the article claims that there is not much evidence the rules will have much effect on doctors’ prescribing habits or on patients’ safety. "Drugs already on the market will have three to seven years to implement these modest changes, and most products that were approved before mid-2001 will not have to modify their labels at all," it says.

The most 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, now in private practice, 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 as being 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 chief of the division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital, Boston, and William Shrank, an instructor at the same institutions.