FDA May Cut Its Losses In Off-Label Promotion Case
This article was originally published in The Pink Sheet Daily
Executive Summary
Amarin, FDA exploring settlement of Vascepa suit; agency could allow Amarin to proceed with its statements and disclosures rather than risk a difficult appeal to Second Circuit, the same court that handed FDA a loss in Caronia three years ago.
You may also be interested in...
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.
RWE: Non-Interventional Studies Must Be Able To Distinguish A True Treatment Effect, US FDA Says
Agency describes a host of issues sponsors should consider and address before pursuing observational or case-control studies to support regulatory decision-making on drug efficacy or safety; new draft guidance was issued under the FDA’s Real-World Evidence program.