fb tracking

Boehringer Ingelheim Pharmaceuticals v. Dep’t of Health and Human Services

The Inflation Reduction Act (IRA) of 2022 contains several reforms designed to lower the high cost of prescription drugs and make them more accessible to patients, including seniors enrolled in Medicare. One such reform is the IRA’s drug price negotiation program, which provides a pathway to lower the prices for a particular set of high-cost drugs—so-called single-source drugs, for which no generic equivalent is currently on the market. The program relies on a process in which the Department of Health and Human Services (HHS), which is responsible for implementing Medicare, and the manufacturer of selected drugs negotiate the prices at which drugs will be made available to Medicare providers and drug plans.

Drug companies have filed lawsuits in courts across the country challenging the IRA program under various theories, including theories under the Constitution’s Takings Clause and Due Process Clause. In each case, Public Citizen, joined by Patients for Affordable Drugs Now, Doctors for America, Protect Our Care, and Families USA, filed an amicus brief in support of the government. Our amicus briefs explain that high prescription drug prices force many Medicare enrollees, including seniors, to cut back on other necessary expenses or forgo medications that they cannot afford, risking adverse health effects and premature death. In addition, because the companies’ theories are based on the faulty premises that drug companies are obligated to participate in Medicare and that the price they prefer to charge Medicare patients is the “market” price from which any reduction in price under the program must be evaluated, our briefs also explain how drug pricing operates in the U.S.

The cases include:

  • Dayton Area Chamber of Commerce v. Becerra (S.D. Ohio) – read our briefs here and here
  • Merck & Co. v. Becerra (D.D.C.) – read our brief here
  • Bristol Myers Squibb Co. v. Becerra (D.N.J.) – read our brief here

On April 29, 2024, the district court granted the agency’s motion for summary judgment and denied the company’s motion. The court held that the program does not effect a taking, does not compel speech, and does not impose an “unconstitutional condition” on the company.

  • Janssen Pharmaceuticals v. Becerra (D.N.J.) – read our brief here

On April 29, 2024, the district court granted the agency’s motion for summary judgment and denied the company’s motion. The court held that the program does not effect a taking, does not compel speech, and does not impose an “unconstitutional condition” on the company.

  • AstraZeneca Pharmaceuticals v. Becerra (D. Del.) – read our brief here

On March 1, 2024, the district court dismissed the case. On the due process issue addressed in our brief, the court held that the claim lacked merit because drug manufacturers do not have a property interest in selling drugs at a price that the government is not willing to pay, and because the IRA program is voluntary, not coercive.

  • Boehringer Ingelheim Pharmaceuticals v. HHS (D. Conn.) – read our brief here

On July 3, 2024, the district court, rejecting each of the company’s constitutional and statutory claims, granted summary judgment in favor of the agency.

  • Novartis Pharmaceuticals Corp. v. Becerra (D.N.J.) – read our brief here
  • Novo Nordisk v. Becerra (D.N.J.) – read our brief here