FDA Approach On Warning Letters, Drug Approvals Could Change Post-Caronia
Industry attorneys suggest FDA warning letters will become more carefully worded and potentially easier to challenge on First Amendment grounds in the wake of the Second Circuit’s decision in the landmark off-label promotion case. FDA’s view of the evidence needed to demonstrate drug efficacy also could evolve.
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If firms could promote drugs for uses not backed by well-controlled studies, it would be “a nightmare,” Temple says; AEI’s Scott Gottlieb suggests the agency might try to regulate how medicines are prescribed.
In a watershed decision, a federal appeals court declares that manufacturers cannot be prosecuted under the FD&C Act’s misbranding provisions solely for speech promoting off-label use of a drug. Industry attorneys predict the decision, if it stands, will change the government’s approach to pursuing such cases.
Office of New Drugs Director Peter Stein tells the Pink Sheet that last phase of massive reorg was complicated by pandemic restrictions that forced review staff to work remotely, but the structural overhaul resulted in smaller, more nimble review groups and the breaking down of silos that ultimately helped the agency’s response to the public health crisis.