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DewDiligence

06/16/23 5:32 PM

#247586 RE: Preciouslife1 #247585

BMY’s own PR on IRA lawsuit:

https://www.bms.com/impact-of-the-inflation-reduction-act-on-innovative-medicines-for-patients.html

June 16, 2023

At Bristol Myers Squibb (BMS), we remain inspired by a single vision: transforming patients’ lives through science. We are constantly working to develop and improve access to life-saving, innovative medicines that will provide hope for more patients and families, investing $9.5 billion in research and development and conducting over 460 clinical trials last year alone.

For example, as a leader in oncology, our scientific breakthroughs have improved how cancer is treated, making long-term survival a possibility for patients across a broad range of solid tumors and blood disorders. The majority of cancer research by the pharmaceutical industry happens after the initial approval as it helps us understand the effect on different patient populations, other types of cancer, and earlier stages of the disease, so more patients can benefit. In fact, nearly 60% of oncology medicines approved a decade ago received approvals for additional indications in later years, and most of those were seven or more years after approval. Unfortunately, this research and progress is now at risk.

Today, we filed a lawsuit challenging the constitutionality of a program in the Inflation Reduction Act (IRA) that requires pharmaceutical companies like BMS, under the threat of significant penalties, to sell their most innovative and effective medicines at government-dictated prices.

Since the IRA’s inception, we have expressed serious concerns about the impact this program will have on research and development and future innovation that can help patients prevail over serious disease. It has already changed the way we look at our development programs in oncology and beyond, whether it’s a decision to advance a new medicine or pursue additional indications for an existing one. This program is bad for innovation—and, in turn, the millions of patients who are counting on the pharmaceutical industry to develop new treatments and cures that save lives and improve health and wellbeing. It also violates the United States Constitution, in at least two ways.

First, the IRA violates the Fifth Amendment, which requires the government to pay a reasonable amount if it takes property for public use. The IRA does this by requiring BMS and other pharmaceutical companies to provide innovative medicines to third parties at prices set by the government, without any requirement that those prices reflect fair market value.

Second, the IRA violates the rights of free speech that are guaranteed by the First Amendment. The IRA makes manufacturers of innovative medicines state publicly that the government's price setting is a true negotiation that resulted in a fair price, even if it was not. The First Amendment protects citizens from just this sort of forced speech.

BMS recognizes the challenges of increasing healthcare costs. We have long supported efforts to meaningfully enhance patient access and lower out-of-pocket costs, and we continue to support provisions in the IRA that will improve affordability for patients who have Medicare coverage for their medicines. We are pleased that the law will help elderly and disabled patients, who are often on fixed incomes, better afford their medicines by capping the amount they have to pay out-of-pocket and allowing them to pay those costs over the course of the year.

We know patients are counting on us to deliver new medicines, and we will continue to advocate for an environment that supports innovation and patient access. BMS has led profound advances in the treatment of cancer, immunological and cardiovascular diseases, and other serious conditions, but our shared focus remains on what we have yet to do.

The arguments are very similar to MRK’s IRA lawsuit (#msg-172068691). It seems pretty likely that these lawsuits will eventually be consolidated.