Astellas Pharma US Statement Regarding the Inflation Reduction Act (IRA)

September 6, 2023

At Astellas, we work every day to develop and provide access to innovative medicines that address the unmet medical needs of patients. We recognize the crucial need for solutions that holistically improve patient access and affordability. We also recognize the importance of preserving an environment that enables investment in the research and development of pioneering treatments for patients.

On September 6, 2023, Astellas requested that the Court dismiss the company’s lawsuit challenging the constitutionality of certain provisions of the Inflation Reduction Act (IRA). However, our decision to withdraw the case does not change our fundamental belief that in its current form, the Medicare Drug Price Negotiation Program (Program) created by the IRA is bad policy and unconstitutional. The price-setting policies in the Program will disrupt the competitive marketplace for prescription drugs in the U.S., disincentivize critical research and development efforts for hard-to-treat conditions, and diminish the availability of new medicines for patients.

Furthermore, while the Program may result in lower costs for the government, it will not necessarily reduce out-of-pocket costs for patients. Astellas has long supported some policies in the IRA, including changes to the Medicare Part D benefit design that established a $2,000 annual cap on what seniors pay for medicines and the ability for beneficiaries to “smooth” costs throughout the year to improve predictability and affordability. However, reform of the system is needed to address misaligned incentives and require pharmacy benefit managers (PBMs) and insurers to share directly with patients the savings they receive from the rebates and discounts biopharmaceutical companies pay them.

Regulatory certainty is a cornerstone of biopharmaceutical innovation. It enables companies like Astellas to commit significant resources and time to discover and develop new medicines for patients. Policies and regulations that diminish transparency and predictability in the marketplace will only discourage private investment, hinder the advancement of timely cutting-edge therapies, and limit access for patients in need.

Astellas will continue to work collaboratively with stakeholders across the healthcare system in support of transparent, market-based policies that help to ensure patient access and affordability while fostering continued medical innovation.

On July 14, 2023, Astellas Pharma US issued a separate statement about legal action regarding the Inflation Reduction Act (IRA).

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