Johnson & Johnson has hopped on the litigation bandwagon, becoming the fourth large drugmaker to sue the U.S. government over drug price negotiations in the Inflation Reduction Act (IRA).
In U.S. District Court in New Jersey, J&J claimed that price negotiations by Medicare would violate the First and Fifth Amendments of the U.S. Constitution. Merck, Bristol Myers Squibb and Astellas have made the same argument in separate lawsuits.
Last week in federal court in Washington, D.C., Merck applied more pressure, filing for a decision in its case without a trial. The U.S. Chamber of Commerce and industry association PhRMA have also filed suits with similar claims.
“The government is forcing (J&J) to provide its innovative, patented medicines on pricing terms that by law must be significantly below market prices,” J&J said in a release. “This would upend the current self-sustaining cycle of pharmaceutical innovation that provides patients with access to pioneering treatments.”
In its suit, which was filed Friday, Astellas used similar language. In a release, Astellas called the drug negotiation program “price setting,” adding that it violates the “Takings Clause, the Due Process Clause and the First Amendment.”
Under the current plan in the IRA, price negotiations will begin in 2026 for drugs that generate the most expenses for the government. According to a report from Moody’s Investors Service, Astellas will have two therapies immediately impacted—Xtandi and Myrbetriq—and J&J stands to face negotiations for Xarelto and AbbVie-partnered Imbruvica.
In its complaint, Astellas noted that it will be forced to sign an agreement on Oct. 1 of this year to participate in the program.
“When that happens, Astellas’s constitutional rights will be violated,” the company wrote.
In its complaint, J&J said that legal remedies could not adequately compensate the company for potential losses of revenue from Xarelto that would result from the negotiation program.
"It is impossible to quantify, replace, or replicate, and the program’s effects will spill over into non-Medicare markets in ways that are equally significant and impossible to quantify," J&J wrote.
Last month, after Merck became the first pharma company to file a lawsuit, Christen Linke Young, deputy assistant to the president for health and human affairs, told reporters on a conference call that there is “nothing in the Constitution that prevents Medicare from negotiating lower drug prices.”