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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.

A landmark appeals court ruling that the government cannot prosecute pharmaceutical manufacturers under the Food, Drug & Cosmetics Act (FD&C) Act’s misbranding provisions solely for off-label promotion likely will reshape the FDA and Justice Department’s approach to bringing such actions but will not foreclose them, industry attorneys say.

In a 2-1 opinion issued December 3, a panel of the Second Circuit US Court of Appeals said...

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In Partnership with Cerba Research

Prioritizing Safety in CAR-T Therapy: Patient Monitoring with Cerba Research’s Testing Portfolio

The cell and gene therapy (CGT) clinical trial landscape in general and CAR-T cell clinical trials in particular are a special focus for the FDA, EMA, and other regulatory agencies. The whole industry is thus aware of the recent FDA safety investigation and requirements for labeling CAR therapy products.

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