US agency wants to limit lawsuits against drug manufacturersBMJ 2006; 332 doi: https://doi.org/10.1136/bmj.332.7535.196-d (Published 26 January 2006) Cite this as: BMJ 2006;332:196
- Jeanne Lenzer
- New York
The US Food and Drug Administration has issued a policy statement that will make it harder for people to sue drug manufacturers. The statement, supporting an arrangement known as “pre-emption,” was inserted into the agency's new guidelines on drug labelling. It asserts that complying with the FDA's labelling requirements should preempt or supersede individual states' liability statutes.
The new statement means that, in the FDA's opinion, as long as a drug company complies with federal labelling laws, the company should not be found in violation of statutes on “failure to warn.” The statement does not have the force of law but may be considered by the courts.
The statement sparked an angry reaction from Edward Kennedy, the Democrat senator for Massachusetts. “It's a typical abuse by the Bush administration: take a regulation to improve the information that doctors and patients receive about prescription drugs and turn it into …