Nationally Recognized Healthcare Experts Oppose AstraZeneca’s Drug Price Negotiation Program Lawsuit

AstraZeneca’s legal challenge to the federal Drug Price Negotiation Program (DPNP) represents a “frontal attack on the Government’s ability to run the Medicare program” and is without merit, according to nine nationally recognized healthcare experts. Yesterday, Zuckerman Spaeder LLP filed an amicus brief on behalf of the experts in support of the Department of Health and Human Services (HHS) opposing a summary judgment motion filed by AstraZeneca. 

The DPNP, a provision of the Inflation Reduction Act, authorizes the federal government “to address astronomical—and quickly growing—drug costs” by negotiating prices paid by Medicare for certain prescription drugs. Drug makers have filed nine lawsuits in six federal courts challenging the DPNP even though, according to the Amici healthcare experts, “the Government’s authority to control costs paid by Medicare is long-standing and fundamental to the program.”

As Amici explain, over the past 50 years, Congress has given HHS the authority to manage the costs of healthcare services paid for by Medicare, and prescription drugs “are the only major component of Medicare that has not been subject to meaningful cost controls.” As a result, the Medicare program has been left “with no leverage over excessive drug prices, which must be borne by Medicare’s beneficiaries and taxpayers.” 

To begin to address skyrocketing drug costs, “the DPNP finally puts some drug manufacturers in a position similar to that faced by Medicare participating providers and physicians.” The brief also explains that other federal agencies have authority to negotiate and control prescription drug costs.

AstraZeneca claims in its lawsuit, filed in August, that the DPNP compels sales of its products at below-market prices in violation of the Fifth Amendment. However, according to Amici in challenges brought against federal healthcare programs under the Fifth Amendment “courts have consistently held that participation in Medicare is voluntary…so the consequences of [AstraZeneca’s] participation cannot be the basis for finding a constitutional violation.”

The brief was submitted by Zuckerman Spaeder on behalf of the following highly regarded experts in healthcare, healthcare finance, and Medicare:

• Stuart Altman, PhD: former Chair of the Prospective Payment Assessment Commission; former Deputy Assistant Secretary at the Department of Health Education and Welfare
• Robert A. Berenson, MD: former Director of Health Plans and Providers at the Health Care Financing Administration; former Vice Chair of MedPAC
• Donald Berwick, MD: former Administrator of the Centers for Medicare & Medicaid Services; former President and CEO of the Institute for Healthcare Improvement
• David Blumenthal, MD: former National Coordinator for Health Information Technology; former President of the Commonwealth Fund
• Francis J. Crosson, MD: former Chair of MedPAC; former member of the National Advisory Committee of the Agency for Healthcare Research and Quality
• Paul Ginsburg, PhD: former Executive Director at the Physician Payment Review Commission (MedPAC predecessor); former Deputy Assistant Director of the Congressional Budget Office
• Marilyn Moon, PhD: former Public Trustee for the Social Security and Medicare Trust Funds; former Chair of the Maryland Health Care Commission
• Robert D. Reischauer, PhD: President Emeritus of the Urban Institute; former Director of the Congressional Budget Office; former Public Trustee of Social Security and Medicare Trust Funds, former Vice Chair of MedPAC
• Bruce Vladeck, PhD: former Administrator of the Health Care Financing Administration; former member of the National Bipartisan Commission on the Future of Medicare

The amicus brief was prepared by Zuckerman Spaeder partners William B. Schultz, who previously served as General Counsel at HHS and Deputy Commissioner for Policy at the Food and Drug Administration, and Margaret "Peggy" Dotzel, who previously served as Acting General Counsel and Deputy General Counsel at HHS, along with associate Alyssa M. Howard. 

The lawsuit is AstraZeneca Pharmaceuticals LP et al. v. Xavier Becerra et al.,1:23-cv-931.