USIJ Opposes CMS Proposal That Undermines Patents for Reformulated Medicines
June 30, 2025
On June 26, 2025, the Alliance of U.S. Startups and Inventors for Jobs (USIJ) submitted comments to express deep concern of the draft guidance under the Medicare Drug Price Negotiation Program that would treat reformulated, separately patented drugs as indistinct from older products. USIJ argues this policy would operate as a de facto price control, undercut valid patent protections, and deter investment in follow-on innovation—such as new formulations or delivery methods that meaningfully benefit patients. USIJ urges the Centers for Medicare & Medicaid Services to reverse course and affirm that reformulated drugs with valid patents and FDA approval qualify as distinct single source drugs under the law.
“Why would any company invest in a subcutaneous version of an infused biologic, explore new dosing regimens, or study new uses for an existing compound if the resulting innovation will be lumped into a pricing category with a decade-old product? The answer is simple: they won’t.”
USIJ Opposes CMS Proposal That Undermines Patents for Reformulated Medicines
On June 26, 2025, the Alliance of U.S. Startups and Inventors for Jobs (USIJ) submitted comments to express deep concern of the draft guidance under the Medicare Drug Price Negotiation Program that would treat reformulated, separately patented drugs as indistinct from older products. USIJ argues this policy would operate as a de facto price control, undercut valid patent protections, and deter investment in follow-on innovation—such as new formulations or delivery methods that meaningfully benefit patients. USIJ urges the Centers for Medicare & Medicaid Services to reverse course and affirm that reformulated drugs with valid patents and FDA approval qualify as distinct single source drugs under the law.