Prescription Drugs

Novartis Pharmaceuticals Corp., v. Novo Nordisk, Inc., et al., v. Xavier Becerra, U.S. Secretary of Health & Human Services, et al. (Filed: 2/2/2024)
The 2022 Inflation Reduction Act (IRA) includes a provision that allows HHS to negotiate the prices for a subset of prescription drugs for the first time in history. In August 2023, HHS announced the 10 drugs that would be included in the first round of negotiations, with prices effective in 2026. In this case, Novo Nordisk, the manufacturer of the diabetes treatment drug NovoLog, which was selected for negotiation, filed a lawsuit challenging CMS’ authority to negotiate prescription drug prices. Novo Nordisk raises First Amendment objections to the program and alleges that the statute violates constitutional separation of powers and due process protections. Novo Nordisk also alleges that CMS violated the Administrative Procedures Act in its promulgation of the IRA and the Social Security Act, and that it acted beyond its authorities delegated by Congress. Novo Nordisk is seeking an order to enjoin the company from having to enter into any agreements around drug prices with CMS under the IRA, find the program unconstitutional, and ultimately end the federal government’s ability to negotiate prescription drug prices for the Medicare program.

ACP policy calls for greater flexibility by Medicare and other publicly funded health programs to negotiate prescription drug prices and supports the adoption of Medicare Part D negotiation models that would drive down the price of prescription drugs for beneficiaries. In this amicus brief, the interested parties argue that America’s unsustainably high prescription drug pricing regime has substantial and escalating negative impacts on public health and patient outcomes. They further argue that this negotiation program is a vital first step in ensuring the health of Americans and sustaining the Medicare program.

Novo Nordisk Inc.; Novo Nordisk Pharma, Inc., v. Xavier Becerra, U.S. Secretary of Health & Human Services et al. (Filed: 12/17/2024) 
In July 2024, a U.S. District Judge rejected Novo Nordisk’s claims of violations of constitutional rights, upholding the federal government’s ability to negotiate Medicare prescription drug prices. Novo Nordisk appealed the ruling to the U.S. Court of Appeals for the Third Circuit, which is where this brief was filed in support of drug price negotiations.

See additional relevant ACP advocacy in the Prescription Drugs and Access to Care sections.

Novartis Pharmaceuticals Corp., v. Xavier Becerra, U.S. Secretary of Health & Human Services, et al. (Filed: 1/19/2024)
The 2022 Inflation Reduction Act (IRA) includes a provision that allows HHS to negotiate the prices for a subset of prescription drugs for the first time in history. In August 2023, HHS announced the 10 drugs that would be included in the first round of negotiations, with prices effective in 2026. In this case, Novartis Pharmaceuticals, the manufacturer of the heart failure treatment drug Entresto, which was selected for negotiation, filed a lawsuit challenging CMS’ authority to negotiate prescription drug prices. Novartis alleges the process violates its 5th Amendment procedural due process rights, argues the excise tax violates 8th Amendment protections against excessive fines, and raises 1st Amendment objections related to unlawfully compelled speech. Novartis is seeking an order to enjoin the company from having to enter into any agreements around drug prices with CMS under the IRA, find the program unconstitutional, and ultimately end the federal government’s ability to negotiate prescription drug prices for the Medicare program.

ACP policy calls for greater flexibility by Medicare and other publicly funded health programs to negotiate prescription drug prices and supports the adoption of Medicare Part D negotiation models that would drive down the price of prescription drugs for beneficiaries. In this amicus brief, the interested parties argue that America’s unsustainably high prescription drug pricing regime has substantial and escalating negative impacts on public health and patient outcomes. They further argue that this negotiation program is a vital first step in ensuring the health of Americans and sustaining the Medicare program.

See additional relevant ACP advocacy in the Prescription Drugs and Access to Care sections.

Boehringer Ingelheim Pharmaceuticals, v. United States Department of Health and Human Services, et al. (Filed: 12/22/2023) 
The 2022 Inflation Reduction Act (IRA) includes a provision that allows HHS to negotiate the prices for a subset of prescription drugs for the first time in history. In August 2023, HHS announced the 10 drugs that would be included in the first round of negotiations, with prices effective in 2026. In this case, Boehringer Ingelheim Pharmaceuticals (BIP), the manufacturer of the diabetes and heart failure treatment drug Jardiance, which was selected for negotiation, filed a lawsuit challenging CMS’ authority to negotiate prescription drug prices. BIP alleges that Congress violated the Nondelegation Clause by permitting HHS to engage in price negotiation without adequate guidance and argues that the process violates its 5th Amendment procedural due process rights. BIP also alleges the regulatory process for establishing the drug price negotiation program did not follow the Administrative Procedures Act.

BIP is seeking an order to enjoin the company from having to enter into any agreements around drug prices with CMS under the IRA, find the program unconstitutional, and ultimately end the federal government’s ability to negotiate prescription drug prices for the Medicare program. ACP policy calls for greater flexibility by Medicare and other publicly funded health programs to negotiate prescription drug prices and supports the adoption of Medicare Part D negotiation models that would drive down the price of prescription drugs for beneficiaries. In this amicus brief, the interested parties argue that America’s unsustainably high prescription drug pricing regime has substantial and escalating negative impacts on public health and patient outcomes. They further argue that this negotiation program is a vital first step in ensuring the health of Americans and sustaining the Medicare program.

Boehringer Ingelheim Pharmaceuticals, Inc., v. Xavier Becerra, U.S. Secretary of Health and Human Services, et al. (Filed: 1/22/2025) 
In July 2024, a U.S. district judge granted the federal government’s request for summary judgement, dismissing BIP’s claims. BIP appealed the ruling to the U.S. Court of Appeals for the Second Circuit, which is where this brief was filed in support of Medicare drug price negotiation under the IRA.

See additional relevant ACP advocacy in the Prescription Drugs and Access to Care sections.

Dayton Area Chamber of Commerce, et al., v. Xavier Becerra, U.S. Secretary of Health & Human Services, et al. (Filed: 12/19/2023) 
The 2022 Inflation Reduction Act (IRA) includes a provision that allows HHS to negotiate the prices for a subset of prescription drugs for the first time in history. In 2023, the Dayton Area Chamber of Commerce, along with the Ohio Chamber of Commerce, Michigan Chamber of Commerce, and U.S. Chamber of Commerce filed a motion for preliminary injunction with the U.S. District Court for the Southern District of Ohio challenging CMS’ authority to negotiate prescription drug prices.

The organization's membership includes numerous pharmaceutical manufacturers subject to the provisions of the IRA. In their memorandum, the Chamber of Commerce alleges that the provisions of the IRA are a violation of 1st and 5th Amendment constitutional rights. ACP policy calls for greater flexibility by Medicare and other publicly funded health programs to negotiate prescription drug prices and supports the adoption of Medicare Part D negotiation models that would drive down the price of prescription drugs for beneficiaries. In this amicus brief, the interested parties argue that America’s unsustainably high prescription drug pricing regime has substantial and escalating negative impacts on public health and patient outcomes. They further argue that this negotiation program is a vital first step in ensuring the health of Americans and sustaining the Medicare program.

See additional relevant ACP advocacy in the Prescription Drugs and Access to Care sections.

AstraZeneca Pharmaceuticals LP & AstraZeneca AB, v. Xavier Becerra, U.S. Secretary of Health & Human Services, et al. (Filed: 11/8/2023) 
The 2022 Inflation Reduction Act (IRA) includes a provision that allows HHS to negotiate the prices for a subset of prescription drugs for the first time in history. In August 2023, HHS announced the 10 drugs that would be included in the first round of negotiations, with prices effective in 2026. In this case, AstraZeneca, the manufacturer of the diabetes, heart failure, and chronic kidney disease treatment drug Farxiga, which was selected for negotiation, filed a lawsuit challenging CMS’ authority to negotiate prescription drug prices. AstraZeneca argues that the provisions of the IRA are a violation of the authorities granted to HHS by statute and that the process violates its 5th Amendment procedural due process rights, and is seeking to nullify any agreements around drug prices it enters with CMS under the IRA, and ultimately end the federal government’s ability to negotiate prescription drug prices for the Medicare program.

ACP policy calls for greater flexibility by Medicare and other publicly funded health programs to negotiate prescription drug prices and supports the adoption of Medicare Part D negotiation models that would drive down the price of prescription drugs for beneficiaries. In this amicus brief, the interested parties argue that America’s unsustainably high prescription drug pricing regime has substantial and escalating negative impacts on public health and patient outcomes. They further argue that this negotiation program is a vital first step in ensuring the health of Americans and sustaining the Medicare program.

AstraZeneca Pharmaceuticals LP & AstraZeneca AB, Bristol Myers Squibb Company, Janssen Pharmaceuticals, Inc., v. Xavier Becerra, U.S. Secretary of Health & Human Services, et al. (Filed 9/16/2024)

On April 29, 2024, the District Court in New Jersey ruled that the Inflation Reduction Act’s drug price negotiation provisions do not violate the First or Fifth Amendments as argued by BMS. BMS appealed the decision, and the appeal was combined with appeals by pharmaceutical companies Janssen and AstraZeneca. The updated brief was filed in the US Court of Appeals for the Third Circuit in support of drug price negotiation and access to prescription drugs for Medicare beneficiaries.

See additional relevant ACP advocacy in the Prescription Drugs and Access to Care sections.

Bristol Myers Squibb Company, v. Xavier Becerra, U.S. Secretary of Health & Human Services, et al. (Filed: 10/23/2023) 
The 2022 Inflation Reduction Act includes a provision that allows HHS to negotiate the prices for a subset of prescription drugs for the first time in history. In August 2023, HHS announced the 10 drugs that would be included in the first round of negotiations, with prices effective in 2026. In this case, Bristol Myers Squibb (BMS), the manufacturer of the blood clot prevention and treatment drug Eliquis, which was selected for negotiation, filed a lawsuit challenging CMS’ authority to negotiate prescription drug prices on the grounds that it violates the First and Fifth amendments. In its challenge, BMS is seeking to nullify any agreements around drug prices it enters with CMS under the IRA and ultimately end the federal government’s ability to negotiate prescription drug prices for the Medicare program.

ACP policy calls for greater flexibility by Medicare and other publicly funded health programs to negotiate prescription drug prices and supports the adoption of Medicare Part D negotiation models that would drive down the price of prescription drugs for beneficiaries. In this amicus brief, the interested parties argue that America’s unsustainably high prescription drug pricing regime has substantial and escalating negative impacts on public health and patient outcomes. They further argue that this negotiation program is a vital first step in ensuring the health of Americans and sustaining the Medicare program.

See additional relevant ACP advocacy in the Prescription Drugs and Access to Care sections.

Janssen Pharmaceuticals, Inc., v. Xavier Becerra, U.S. Secretary of Health & Human Services, et al. (Filed: 10/23/2023) 
The 2022 Inflation Reduction Act includes a provision that allows HHS to negotiate the prices for a subset of prescription drugs for the first time in history. In August 2023, HHS announced the 10 drugs that would be included in the first round of negotiations, with prices effective in 2026. In this case, Janssen Pharmaceuticals, the manufacturer of blood clot prevention and treatment drug Xarelto, which was selected for negotiation, filed a lawsuit challenging CMS’ authority to negotiate prescription drug prices on the grounds that it violates the First and Fifth amendments. In its challenge, Janssen is seeking to nullify any agreements around drug prices it enters with CMS under the IRA and ultimately end the federal government’s ability to negotiate prescription drug prices for the Medicare program.

ACP policy calls for greater flexibility by Medicare and other publicly funded health programs to negotiate prescription drug prices and supports the adoption of Medicare Part D negotiation models that would drive down the price of prescription drugs for beneficiaries. In this amicus brief, the interested parties argue that America’s unsustainably high prescription drug pricing regime has substantial and escalating negative impacts on public health and patient outcomes. They further argue that this negotiation program is a vital first step in ensuring the health of Americans and sustaining the Medicare program.

See additional relevant ACP advocacy in the Prescription Drugs and Access to Care sections.

Merck & Co., Inc., v. Xavier Becerra, U.S. Secretary of Health & Human Services, et al. (Filed: 9/18/2023) 
The 2022 Inflation Reduction Act includes a provision that allows HHS to negotiate the prices for a subset of prescription drugs for the first time in history. In August 2023, HHS announced the 10 drugs that would be included in the first round of negotiations, with prices effective in 2026. In this case, Merck, the manufacturer of the diabetes drug Januvia, which was selected for negotiation, filed a lawsuit challenging HHS’ authority to negotiate prescription drug prices on the grounds that it violates the First and Fifth amendments.

ACP policy calls for greater flexibility by Medicare and other publicly funded health programs to negotiate prescription drug prices and supports the adoption of Medicare Part D negotiation models that would drive down the price of prescription drugs for beneficiaries. In this amicus brief, the interested parties argue that America’s unsustainably high prescription drug pricing regime has substantial and escalating negative impacts on public health and patient outcomes. They further argue that this negotiation program is a vital first step in ensuring the health of Americans and sustaining the Medicare program.

See additional relevant ACP advocacy in the Prescription Drugs and Access to Care sections.