Off-Label Promotion Ruling Presents Hidden Risks For Pharma Companies, Lawyers Say
Executive Summary
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.
You may also be interested in...
Off-label Ruling’s Potential Fallout Is “Terrifying,” FDA’s Temple Says
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.
Off-Label Enforcement, Not Promotion, May See First Changes After Free Speech Ruling
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.
Rare Diseases: CBER Looks To ‘Lean Into’ Accelerated Approval, Align More With CDER
US FDA biologics center officials spoke about their efforts to increase collaboration and harmonization with the drugs center, and to internally involve more review disciplines in evaluating biomarker evidence, during a Reagan-Udall Foundation meeting that weighed potential use of accelerated approval for neuronopathic mucopolysaccharidoses disorders.