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The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovative biopharmaceutical research companies, which are laser focused on developing innovative medicines that transform lives and create a healthier world. Together, we are fighting for solutions to ensure patients can access and afford medicines that prevent, treat and cure disease. Over the last decade, PhRMA member companies have invested more than $850 billion in the search for new treatments and cures, and they support nearly five million jobs in the United States.

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PhRMA urges CMS to reconsider a proposal that could discourage investment in new treatments designed to be more convenient and accessible for patients. CMS already uses extremely broad criteria to determine which drugs are eligible for price setting under the Inflation Reduction Act. For example, any form of a medicine from the same manufacturer with the same active ingredient or moiety is automatically swept into price setting, even if it represents a significant advancement for patients. But now, CMS is proposing to expand this flawed, unsupported interpretation of the statute to group certain new, combination medicines, referred to as fixed-dose combinations, with older, single-ingredient drugs if the differing active ingredients create a new formulation that enables an alternative route of administration.

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Government Price Setting

PhRMA Comments on Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program Proposed Rule (CMS-4215-P)

August 17, 2026

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