Lawmakers query FDA on labeling rule

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Eight House and Senate health overseers are challenging the FDA's use of limited resources to prepare a proposed rule on when medical product companies can make safety-related labeling changes without prior approval. In a letter to Andrew von Eschenbach they said the proposal was “apparently designed to shield…companies from liability for injuries sustained by American consumers as a result of unsafe products.”

Earlier, the FDA published the proposed rule in the Federal Register and said it was codifying “the agency's understanding that a CBE supplement is appropriate to amend the labeling for an approved product only to reflect newly acquired information, and to clarify that a CBE supplement may be used to add or strengthen a contraindication, warning, precaution, or adverse reaction only if there is sufficient evidence of a causal association with the approved product.”

In the letter, the members say the FDA “failed to provide any justification for expending its very limited resources on issuing this 26 page proposal that will serve only to deprive American consumers of critically important and timely information about the safety of their drugs and medical devices…The issuance of the proposed CBE rule is not an isolated case, but part of a pattern of actions in the administration's final months to permanently insulate the drug and device industry from liability.”

The letter takes issue with the assertion that the proposal codifies the agency's longstanding view on when a labeling change may be made. “To the contrary, the proposed changes would instead drastically limit the situations in which a manufacturer is permitted to make add or strengthen a contraindication, warning, precaution, or adverse reaction without waiting for FDA to approve such a change. Under FDA's proposal, a manufacturer would now 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.'”
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