What Patients Need to Know

About the Inflation Reduction Act’s Healthcare Provisions

How Government Price-Setting Hurts Patients

Enacted in 2022, the Inflation Reduction Act (IRA) jeopardizes drug development and patient access to critical treatments, notably through its Medicare “price negotiation” provision, which is effectively government price-setting. Europe’s experience with similar policies led to a collapse in drug development and worse health outcomes including significantly higher cancer mortality rates. Consequently, numerous patient advocacy groups are opposing the implementation of government price-setting in the U.S.

400,000 more deaths each year

If U.S. cancer patients had European cancer death rates

60% of new drugs

are developed in the U.S.

90% of new medicines

are available to U.S. patients within the first year of launch

Latest News

How IRA Price Setting Disccourages Biosimilar Development

In a recent op-ed in USA Today, Rutgers University professor Sandip Shah, argues that the price-setting provisions of the Inflation Reduction Act (IRA) are unintentionally disincentivizing biosimilar development:

The IRA permits Medicare officials to impose price controls on certain brand-name drugs, including many biologics. But the government does not have to reveal which medicines will be subject to price caps until just two years prior to the lower prices taking effect. As a result, a firm could hypothetically spend nearly a decade and hundreds of millions of dollars developing a biosimilar — only to find out that the original brand-name biologic will suddenly be much cheaper, courtesy of government price controls. In such a scenario, the biosimilar developer would be unable to gain enough market share to break even on its R&D investments, let alone earn a modest return.

Lawmakers can restore incentives for biosimilar drug makers by automatically — and permanently — exempting from price controls any biologic for which there is a biosimilar competitor in development. Unless and until that happens, the legacy of the Inflation Reduction Act will be reduced access to low-cost biosimilars — ultimately leading to higher drug spending. 

The Inflation Reduction Act’s First Potential Impact on Biosimilars

On October 31, 2023, FDA approved Amgen’s Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Janssen’s Stelara (ustekinumab). Stelara has been selected by the Center for Medicare & Medicaid Services (“CMS”) as one of the first 10 drugs subject to the Inflation Reduction Act’s (“IRA’s”) price negotiations. Because of price caps that the IRA will impose on Stelara, Wezlana will face a different competitive landscape than the six interchangeables for other drugs approved to date. Wezlana’s example calls into question whether the IRA will disincentivize the development of biosimilars for the most popular biologics at a time when more biosimilars are critical to reducing healthcare costs.

In Shocking Reversal, CMS Wants to Allow Medicare Part D Plan Sponsors to Substitute Non-Interchangeable Biosimilars

Medicare Price “Negotiations” Will Jeopardize Patient Access to New Medicines, Result in Worse Health Outcomes

Over the next 4 years, Medicare will set prices for up to 60 drugs covered under Medicare Part D and Part B. This shortsighted move won”t control costs and threatens to limit patient access to new medicines, ultimately resulting in worse health outcomes for U.S. patients, warns ASBM.

Medicare Drug Price Negotiation Program Guidance

The Inflation Reduction Act – Implications for Biopharma Companies and Patients

“ASBM fears that the downstream effects of broad government price setting will ultimately reduce consumers’ choice of plans and formularies in Part D—aspects considered to be hallmarks of the program.”

In the NEws

Doubling Down On Drug Price Controls Could Hurt Patients

In the drug space, sources ranging from the Congressional Budget Office and analytics firms to university economists, and health-industry analysts warn that IRA price setting will also deter crucial investments in research and development, resulting in fewer new medicines.

International BUsiness Times | Joel White – View onLINE

Relay Therapeutics Pauses Lirafugratinib Rare Cancer Plans Due to IRA

Relay Therapeutics announced plans Thursday to shift gears, pausing its push for rare cancer and switching focus to the larger tumor-agnostic market. The Boston-based biotech is pointing to the Inflation Reduction Act as a driving factor of its decision. 

Biospace | Kate Goodwin – View onLINE

Life Sciences Masters Panelists Warn of IRA Impact on Innovation

IPWatchdog’s Life Sciences Masters 2023 concluded today, following three days of panels that tackled some of the most pressing issues facing intellectual property professionals in the life sciences space.

IP Watchdog | Eileen McDermott – View onLINE

Kenneth E. Thorpe: Pill penalty will devastate cancer research

The Biden administration just announced a new initiative to improve cancer outcomes in low-income communities across the United States. It’s sorely needed. Research shows cancer mortality is more than 10 percent higher in communities experiencing persistent poverty compared to those that aren’t.

Hartford Courant | Kenneth E. Thorpe – View on Press Reader

Amend law to combat skyrocketing colorectal cancer rates (opinion)

Drug-pricing rules in Inflation Reduction Act will stymie efforts to develop new treatments.

Reading Eagle | Andrew Spiegel

Merck Sues to Stop the IRA's 'Extortion'

If an assailant points a gun at your head and threatens to shoot if you don’t hand over your wallet, is that a negotiation? This describes the Inflation Reduction Act’s Medicare drug-price scheme, which Merck & Co. claims is “extortion” and unconstitutional in a compelling lawsuit filed Tuesday. Merck v. Becerra may be destined for the Supreme Court.

WSJ | Editorial Board

Drug shortages: a multifaceted problem

The number of backordered medicines in Sweden increased by over 50 per cent in 2022. Drug shortages, which are major problems across the EU, have led to a lively debate on how the region can ensure a stable flow of essential medicines. Right now, all EU countries’ medicines agencies are meeting in Malmö to discuss how to resolve the situation.

BioStock | Staff

Mitigating the Inflation Reduction Act’s Adverse Impacts on the Prescription Drug Market

The purported goal of the Inflation Reduction Act (IRA) of 2022 is to lower healthcare costs for Americans.

USC Schaeffer | Dana Goldman, PhD, Joseph Grogan, JD,Darius Lakdawalla, PhD,Barry Liden, JD,Jason Shafrin, PhD,Kyi-Sin Than, MPHandErin Trish, PhD

The Ultimate Price Of Government Price Controls

Democrats have nudged the U.S. healthcare system closer to Canadian-style socialism with their recently signed, and dubiously named, Inflation Reduction Act.

Forbes | Sally Pipes


Learn more about IRA price controls and spread the word with these print and digital materials.


Emerging Value in Oncology

July 2023
How ongoing research expands the benefits of oncology  medicines

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Lilly Sidelined Three Drugs Due To IRA, CEO Ricks Says

Eli Lilly & Co. CEO David Ricks highlighted how Medicare drug price negotiation policies are already impacting R&D investment during a J.P. Morgan investor call.

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KOL Conversation: The Impact of the IRA on Oncology Patient Care

Features an interview with Dr. Barbara L. McAneny, MD, FASCO, MACP Former President for the American Medical Association and the New Mexico Medical Society (NMMS); and currently CEO, New Mexico Cancer Center.

With Dr. Steve Potts CEO, Anticipate Bioscience
May 26, 2023