News Briefs: Drugmakers Prep Legal Challenges to Medicare Price Negotiation
Major pharmaceutical companies are gearing up to file legal challenges to the Medicare price negotiation provisions in the Inflation Reduction Act, Reuters reported. Industry sources who spoke with the news outlet said drugmakers plan to argue that a ban against discussing the price negotiation process violates their First Amendment rights, and that the $1 million per day fine for violations runs afoul of the Eighth Amendment’s protections from excessive fines. Sources also indicated that lawsuits could challenge the legality of initial guidance CMS issued in March regarding the Medicare price negotiation program, as it did not go through a formal process with proposed and final rules. Five of the world’s top drugmakers sent CMS letters raising legal concerns about the Medicare price negotiation program, but they have not yet been made public; CMS said it plans to publish the letters in July when it finalizes its guidance and regulations implementing the program.