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

Earlier, the FDA published the proposed rule in the FederalRegister and said it was codifying “the agency’s understanding that a CBEsupplement is appropriate to amend the labeling for an approved product only toreflect newly acquired information, and to clarify that a CBE supplement may beused to add or strengthen a contraindication, warning, precaution, or adversereaction only if there is sufficient evidence of a causal association with theapproved product.”

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

The letter takes issue withthe assertion that the proposal codifies the agency’s longstanding view on whena labeling change may be made. “To the contrary, the proposed changes wouldinstead drastically limit the situations in which a manufacturer is permittedto make add or strengthen a contraindication, warning, precaution, or adversereaction without waiting for FDA to approve such a change. Under FDA’sproposal, a manufacturer would now be prohibited from adding or strengthening acontraindication, warning, precaution, or adverse reaction in the absence ofFDA approval unless there is ‘evidence of a causal association.’”