FDA May Cut Its Losses In Amarin Off-Label Promotion Case
This article was originally published in The Tan Sheet
Amarin and FDA explore settlement of Vascepa suit. The agency could allow Amarin to proceed with its statements and disclosures rather than risk a difficult appeal to the Second Circuit, the same court that handed FDA a loss in Caronia three years ago.
You may also be interested in...
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.
Agency wants to ensure patients ‘aren’t unnecessarily or unfairly scared off or intimidated’ from taking biosimilars, Office of Therapeutic Biologics and Biosimilars' acting policy director Eva Temkin tells the FDA/CMS Summit; Temkin says recent guidance on biosimilar insulins shows agency is trying to be flexible on interchangeability data requirements.
AstraZeneca and Merck seek to add a pancreatic cancer indication for olaparib, while Merck has hopes of broadening pembrolizumab’s use in bladder cancer; two-day Oncologic Drugs Advisory Committee meeting also will include reviews of Celgene’s luspatercept in myelodysplastic syndromes-related anemia and Epizyme’s tazemetostat for epithelioid sarcoma.