Off-Label Promotion Ruling Presents Hidden Risks For Pharma Companies, Lawyers Say
An appeals court ruling that bars prosecution solely for speech promoting off-label use carries with it potential negative ramifications for the pharmaceutical industry, including liability under state consumer protection laws and greater government scrutiny of internal marketing documents.
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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.