MEMBERS OF CONGRESS QUESTION FDA PROPOSAL DESIGNED TO CREATE LIABILITY SHIELD FOR DRUG AND DEVICE COMPANIES
WASHINGTON, DC—Today Representatives Henry A. Waxman, John D. Dingell,
Frank Pallone, Jr., Rosa L. DeLauro, and Edward Markey, and Senators Edward M.
Kennedy, Patrick J. Leahy, and Christopher J. Dodd, questioned the basis for a new Food
and Drug Administration (FDA) proposal that was apparently designed to shield
pharmaceutical and device companies from liability for injuries sustained by American
consumers as a result of unsafe products.
“We are concerned that the intent of this proposal is to protect companies in the
pharmaceutical and device industry from being held liable for marketing products they
know are unsafe,” said the members in a letter to FDA Commissioner von Eschenbach.
“Such a policy change comes at the expense of consumers and violates the mission of the
FDA.”
FDA’s proposed rule would amend the regulations that permit companies to promptly
update their drug and device labels with new safety information without waiting for FDA
approval. These regulations serve the vitally important public health function of ensuring
that patients and healthcare providers are made aware of safety risks associated with their
medical products at the earliest possible moment.
Given that FDA failed to identify a public health basis for why this lengthy proposal was
necessary at this point in time, the letter’s authors ask FDA to answer questions justifying
the expenditure of the agency’s limited resources on this effort.
The complete text of the letter follows: