A portion of the Inflation Reduction Act (IRA) that affords federal officials certain negotiating liberties pertaining to top-selling medications has been dealt yet another blow, as the list of entities suing over the measures continues to grow.
New York-based pharmaceutical giant Bristol Myers Squibb (BMS) has filed suit against the U.S. Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) over parts of the IRA that enable the U.S. government to negotiate voluntary price reduction agreements for certain medications. BMS suggested that the price adjustments could hinder the pharmaceutical industry's ability to develop new medications.
“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,” the June 16 announcement from BMS states. “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.”
The violations BMS is referring to are the First and the Fifth Amendments of the U.S. Constitution—the same violations Merck and the United States Chamber of Commerce referenced in their own lawsuits against the new IRA provisions.
In response to Merck’s lawsuit, which was filed on June 6, the Biden administration stayed steadfast in its position.
"We are confident we will succeed in the courts: there is nothing in the Constitution that prevents Medicare from negotiating lower drug prices," White House spokeswoman Karine Jean-Pierre said in a statement.
As for BMS, the company indicated that the Drug Price Negotiation Program has already changed the way it is looking at the development of future oncology programs and medications.
The full BMS statement is available here.