Eight leading US Democratic legislators have urged Food and Drug Administration Commissioner Andrew von Eschenbach to withdraw plans to amend regulations which currently permit manufacturers of drugs, biologics and medical devices to update product labels with new safety information without waiting for the agency to approve the change.

They say the proposal will lead to far fewer industry-initiated warnings, thus depriving consumers of critically-important and timely product safety information, and claim that the plan “has no other purpose other than to shore up the industry’s legal arguments for avoiding liability.”

Moreover, the proposal is “part of a pattern of actions in the Bush Administration’s final months to permanently insulate the drug and device industry from liability,” the legislators claim in a letter to the Commissioner.

The rules at issue, known as the “changes being effected supplement 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, say the signatories to the letter, who include Senators Edward Kennedy and Patrick Leahy, chairmen, respectively, of the Senate Committees on Health, Education, Labor and Pensions (HELP) and of the Judiciary, and Representatives Henry Waxman and John Dingell, who chair the House Committees on Oversight and Government Reform, and on Energy and Commerce, respectively. They dismiss the agency’s statement that the Proposed Rule is simply an effort to “codify” its long-standing view on when a change to labeling may be made in advance of agency review and claim that, in fact, it would set a much higher standard than previously applied in FDA regulations and, inevitably, result in fewer company-initiated warnings.

Agency fails to justify proposal
Moreover, they tell Commissioner von Eschenbach that the agency has failed to provide any justification for issuing this proposal or to identify a single problem associated with the regulations which would warrant modification, adding: “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.”

The proposal has been cited "immediately" by the Solicitor General in a letter to the US Supreme Court in support of the industry’s argument that FDA approval pre-empts individual product liability cases, note the signatories, who also include Senators Christopher Dodd and Rosa DeLauro and Representatives Edward Markey and Frank Pallone Jr.

The Administration “has turned its back on American consumers," they say, adding: “A time when the FDA lacks to resources to adequately protect Americans from unsafe drugs and devices, it is astonishing that the Bush Administration has opted to dedicate FDA’s strained resources to protecting the drug and device industry from liability for marketing dangerous products.”

The eight leading Democrats have asked that Commissioner von Eschenbach respond to the concerns expressed in their letter no later than February 13. The FDA published its Proposed Rule in the Federal Register on January 16, and is asking for responses by March 17. Lynne Taylor