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CMS Final Guidance on Government-Mandated Drug Pricing Highlights Need for Renewed Focus on...

CMS Final Guidance on Government-Mandated Drug Pricing Highlights Need for Renewed Focus on Patients, Jobs and Cures

Latest Announcement Coincides with New Study that Projects Devastating Losses Across Biopharma Ecosystem


July 7, 2023

Washington, DC – On Friday, June 30, the Centers for Medicare and Medicaid Services (CMS) released final guidance on the Inflation Reduction Act’s government-mandated drug pricing provisions, including information regarding how the agency will select drugs subject to government-mandated drug pricing, develop initial mandated prices and establish requirements for manufacturers of selected drugs.

“While CMS’ latest guidance took a few initial steps forward, we still face a future in which patients experience devastating impacts that will decimate local economies, cost high-paying jobs, and prevent FDA-approved medicines from coming to market. The recent action by CMS underscores the need for policymakers to shift focus to the unintended consequences of the IRA and actively seek out near-term opportunities to help preserve patient access and support innovation,” said Tom Kowalski, national co-chair of We Work For Health. “We are hopeful that Congress will now focus on the right fixes to reverse harmful price setting legislation, including incentives for small molecule medicines. Unfortunately, the clock is ticking for millions of patients who are negatively impacted by bureaucratic process that will prevent innovative medicines from coming to market.”

CMS’ guidance comes on the heels of a new study showing serious consequences for the development of and investment in new medicines, as well as significant job losses in major innovation hubs across a number of states if proposals to expand government-mandated drug pricing policies are implemented.

Key Study Highlights:

The We Work for Health-Vital Transformation study found that, if proposed expansions of government-mandated drug pricing policies are implemented, there would be serious consequences around the development of and investment in new medicines, and significant job losses in major innovation hubs across a number of states.

  • Lost Therapies: More than 80 currently available therapies of 121 identified for price setting – approximately 70% – would likely not have been developed had the pricing provisions been in place prior to their development.

  • Lost Innovation: There would be 237 fewer FDA approvals of new medicines or new uses over a 10-year period. Impacts of the proposed policies will be felt most heavily in many areas of unmet need, particularly in oncology, neurology, and rare and infectious diseases.

  • Lost Jobs & Investment: This would result in a loss of 146,000-223,000 direct biopharmaceutical industry jobs and a total loss of 730,000-1,100,000 U.S. jobs across the economy. There would be loss of ecosystem investments into 50 different therapeutic indications, concentrated primarily in California, Massachusetts and New York.


About We Work For Health

Since 2007, We Work For Health (WWFH) has been bringing together national and local business leaders, labor, biopharma, patient advocacy, and other healthcare-related stakeholders. WWFH is dedicated to promoting policies and initiatives that not only foster innovation and facilitate the delivery of lifesaving or life-enhancing medicines, but also value both the workforce and significant contributions of the biopharmaceutical sector to economies at the national, state, and local levels.



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