Amarin, Pharmaceutical Research and Manufacturers of America cardiovascular news
PhRMA and a coalition of pharmas criticized FDA’s position on drug manufacturers’ ability to distribute information about off-label drug usage, calling the agency’s position a violation of the First Amendment to the U.S. Constitution. PhRMA, the Medical Information Working Group (MIWG) and the Washington Legal Foundation (WLF) filed amicus briefs supporting Amarin in its lawsuit against FDA. Amarin alleges FDA regulations violate the First Amendment because they prevent 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, May 18).
According to Amarin’s suit, FDA interprets off-label promotion by a drug manufacturer as misbranding, putting Amarin at risk for criminal prosecution. Amarin is seeking a declaration that FDA’s regulations are unconstitutional and preliminary and permanent injunctions to prevent FDA from taking action against Amarin on the basis of truthful, non-misleading speech used in off-label promotion of Vascepa. Earlier this month, FDA issued a response to Amarin’s suit stating that it decided not to approve Amarin’s sNDA seeking to add claims about treatment of cardiovascular disease to Vascepa’s label because data are insufficient to support lowering triglyceride levels as a surrogate for reducing CV disease risk. However, FDA said it would not object if Amarin distributed articles from peer-reviewed journals about the ANCHOR trial or truthful, non-misleading summaries of the trial. FDA also said it is “engaged in a comprehensive review of its regulations and guidance documents regarding manufacturers’ dissemination of information regarding their medical products, and new guidance will be forthcoming.” ...