Proposed rules limit when drug manufacturers can change warnings labels without FDA approval
The Bush administration wants to limit the situations where drug companies can change warning labels when they know of unsafe conditions without waiting for government approval.
But Democrats charge that the recent proposal from the Food and Drug Administration (FDA) is a ploy to shield drug companies from liability for unsafe products.
FDA’s proposed rule concerns regulations that permit companies to promptly update their drug and device labels with new safety information without waiting for FDA approval.
The FDA says its recent proposal would merely “codify the agency’s longstanding view on when a change to the labeling of an approved drug may be made in advance of the agency’s review of such change.”
But 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 say the proposal does more than just codify current practice.
The Democrats argue that the proposal would instead “drastically limit the situations” in which a manufacturer is permitted to alter a warning label without waiting for FDA to approval.
FDA’s current regulations permit manufacturers to change their labels to add or strengthen a contraindication, warning, precaution, or adverse reaction without waiting for approval by the FDA of such a change. Known as the “changes being effected (CBE) supplements” regulations, they are meant to ensure that patients and health care providers are made aware of safety risks associated with their medical products at the earliest possible moment.
Under FDA’s proposal, a manufacturer would be prohibited from adding or strengthening a contraindication, warning, precaution, or adverse reaction in the absence of FDA approval unless there is “evidence of a causal association.” Critics contend that this is a much higher standard than was previously applied in FDA’s regulations and “will inevitably result in fewer company-initiated warnings.”
In a letter to FDA Commissioner Andrew C. von Eschenbach, the Democrats said they want to know why the FDA is making this move.
In their view, it is designed to bolster the argument by companies defending against lawsuits that the regulations precluded them from adding warnings, precautions, and adverse reactions in the absence of FDA approval, whereas under FDA’s current regulations, they would have been free to do so.
“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 Democrats in a letter to FDA Commissioner Andrew C. von Eschenbach.
They said the FDA failed to identify a public health basis for why this proposal was necessary at this point in time. They said the FDA has not identified a single problem with these regulations that would warrant a change. The letter’s authors ask FDA to justify the expenditure of the agency’s resources on this effort.
“Such a policy change comes at the expense of consumers and violates the mission of the FDA. The issuance of the proposed CBE rule is not an isolated case, but part of a pattern of actions in the Bush Administration’s final months to permanently insulate the drug and device industry from liability,” they wrote.
The Democrats charge that the 26 page CBE proposal has “no purpose other than to shore up the industry’s legal arguments for avoiding liability.”
The FDA proposal was immediately cited by the Solicitor General in a letter to the U.S. Supreme Court in support of the drug industry’s argument that FDA approval preempts individual product liability cases, according to the Democrats.
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