DOJ Unlikely To Take Off-Label Promotion Case To Supreme Court, Attorneys Say
This article was originally published in The Gray Sheet
Executive Summary
The recent appellate court case U.S. v. Caronia was viewed as a victory for pharmaceutical companies in terms of truthful, off-label promotion, and as the government assesses its next move, attorneys project the case won’t make it to the Supreme Court.
You may also be interested in...
Amarin's Statements Allowed Under Caronia Ruling, Court Says
First Amendment protection extends to truthful and non-misleading statements about unapproved uses that sales reps proactively make to doctors.
FDA Twitter Guidance Lacks Flexibility, And May Be Unconstitutional, Critics Say
Stakeholders say the agency’s communication requirements for space-limited online platforms are too restricting and violate the First Amendment. Many of them are calling on the agency to withdraw the guidance and try again. The device industry has a comparatively toned down response so far, but wants more flexibility.
News In Brief
News on DePuy hip liability suits, U.S. v. Caronia and more.