28:2201 Constitutionality of State Statute(s)
When Amarin Pharma this month nailed down a seismic win for Big Pharma's off-label marketing, it was the climax of a First Amendment case painstakingly developed by three seasoned attorneys at Cahill Gordon & Reindel LLP. In an interview with Law360, they discussed the case's origins, why it succeeded and where things go from here.
Amarin Pharma and the U.S. Food and Drug Administration on Tuesday finalized in New York federal court a long-awaited settlement of First Amendment litigation over restrictions on off-label promotion, capping a seminal case for oversight of prescription drug claims.
A New York federal judge on Thursday halted a suit between Amarin Pharma Inc. and the U.S. Food and Drug Administration — in which the court had previously ruled Amarin can make certain truthful statements about off-label uses of its omega-3 drug Vascepa — while the two chisel out a settlement.
Amarin Pharma Inc. and the U.S. Food and Drug Administration have agreed to discuss settlement options following the company's landmark win in a suit in which a New York federal judge upheld drugmakers' right to truthfully promote their products' unapproved uses, Amarin's lawyers said in a Friday letter.
Amarin Pharma Inc.'s landmark win in its New York federal suit against the U.S. Food and Drug Administration upholds drugmakers' right to truthfully promote their products' unapproved uses, but attorneys say this expanded marketing can inadvertently supply more fodder — without the FDA's imprimatur — for failure-to-warn lawsuits.
A landmark court decision on Friday allowing truthful and nonmisleading off-label promotion by Amarin Pharma Inc. provides a roadmap for drugmakers to market products more freely, but attorneys say much uncertainty remains about the ruling's impact on criminal misbranding cases and False Claims Act litigation. Here are five questions raised by Amarin’s victory.
A New York federal judge on Friday ruled that Amarin Pharma Inc. has a constitutional right to make certain truthful and nonmisleading statements about off-label uses of omega-3 drug Vascepa, striking a blow to the U.S. Food and Drug Administration’s restrictions on product marketing.
A New York federal judge on Tuesday appeared unlikely to immunize Amarin Pharma Inc. from punishment by the U.S. Food and Drug Administration for engaging in off-label promotion, while nonetheless suggesting that certain truthful statements may be constitutionally protected.
The pharmaceutical industry is poised for important court developments involving off-label marketing, biosimilars exclusivity, False Claims Act liability and the 340B drug-discount program. Here are four cases that attorneys will be tracking closely in the second half of 2015.
Amarin Pharma Inc. on Tuesday urged a New York federal judge to protect its off-label marketing of fish oil drug Vascepa, saying the U.S. Food and Drug Administration hasn’t removed the threat of punishment that would violate First Amendment rights.