Industry groups fight<span class="*Red-type+bold"> FDA in free speech suit

The Pharmaceutical Research and Manufacturers of America (PhRMA) and a coalition of pharmas criticized FDA's position on drug manufacturers disseminating information about off-label drug use, calling the agency's position a violation of the First Amendment to the U.S. Constitution.

PhRMA and the Medical Information Working Group (MIWG), along with the Washington Legal Foundation (WLF), filed amicus briefs this week supporting Amarin Corp. plc (NASDAQ:AMRN) in its lawsuit against FDA. Amarin alleges FDA regulations violate the First Amendment because they have prevented the company from providing "truthful and non-misleading information" to healthcare professionals about off-label use of Vascepa icosapent ethyl to treat cardiovascular disease (see BioCentury Extra, May 8). ...