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CSBA Comments to Centers for Medicare & Medicaid Services (CMS) on Medicare Drug Price Negotiation Program: Initial Memorandum, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2026

April 14, 2023

The CSBA Board of Directors endorses BIO’s formal comments on
the Medicare Drug Price Negotiation Program, which are appended to this letter.


Download Full Comments Below
CSBA Final to CMS with BIO Letter
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In these comments, BIO addresses FDA’s four specific topic areas of consideration as the agency develops its draft guidance per PDUFA VII.
BIO joined with more than 40 groups in calling on Congress to set 2024 funding for the U.S. Codex Office at or above the 2023 level. 
BIO’s comments support accelerated approval as an important regulatory pathway that allows patients with serious and life-threatening illnesses such as cancer to have earlier access to promising therapies.