Amicus Brief on Behalf of Leading Pharmaceutical Companies Urges D.C. Circuit to Reject Unlawful CMS Guidance on IRA Drug Price Negotiation Program

• Bausch Health Companies Inc., Bristol Myers Squibb Company, Eli Lilly and Company, Johnson & Johnson, Sanofi-Aventis U.S. LLC, and the Biotechnology Innovation Organization have filed an innovators' amicus brief supporting Teva Pharmaceuticals' appeal of a federal ruling that upheld CMS guidance on the Inflation Reduction Act's Drug Price Negotiation Program (DPNP).
• The amicus effort, led by an Orrick team, argues that CMS exceeded its authority by subjecting newly approved medicines to forced sales under the DPNP. Congress intended only for products that have been on the market for a specific number of years to be subject to the DPNP and not before. CMS's guidance unlawfully aggregates products with the same "active moiety" - a concept not in the statute - into one fictional "super drug" subject to the DPNP, regardless of whether each distinct product may have only recently obtained FDA approval to enter the market. That aggregation violates the limits Congress prescribed for the DPNP and threatens innovation.
• The brief highlights the real-world stakes: fewer post-approval trials, reduced R&D investment, and delayed or shelved therapies that would benefit patients. This innovators' brief urges the D.C. Circuit to reverse the district court's ruling, reject CMS's unlawful expansion of the DPNP, and protect the incentives that drive life-saving innovation.

The Orrick team on the amicus effort is led by partners Irena Royzman, Clement Roberts and Cesar Lopez-Morales, and includes Lauren Shepard.