Off-Label Promotion Ruling Increases Pressure For FDA Policy Change
This article was originally published in Clinica
Executive Summary
Amarin Corp. PLC's First Amendment legal victory on Vascepa (icosapent ethyl) may intensify pressure on FDA to develop new guidance and regulations governing off-label promotion before its hand is further forced by more adverse court rulings and Congress.
You may also be interested in...
Experts Debate Prospects Of Third-Party Agency To Oversee Off-Label Communications
The Duke-Margolis Center has released a list of policy changes that experts argue could improve how off-label communication is disseminated. Among the proposals is a third-party organization to vet off-label communication and a tiered labeling system.
FDA Seeks To Resolve First Amendment Suit By Pacira
Judge extends date for agency response to firm's complaint as parties continue settlement talks; case reveals two chinks in FDA’s off-label regulatory regime armor, former FDA advisor says.
Proposed Intended-Use Amendments Invite Questions About FDA's Off-Label Intentions
The agency issued a proposed rule addressing tobacco regulation last month that also includes amendments regarding "intended uses" of devices and drugs. It could offer an opportunity for companies to get more clarity from FDA on off-label promotion issues. But one attorney says it's frustrating that FDA neglected to incorporate any recent feedback from the courts that its enforcement of off-label marketing runs afoul of the First Amendment.