Let the drug negotiations begin! Pharma opts in, even while suing feds to stop the program

All the manufacturers of the first 10 prescription drugs selected for Medicare price negotiations agreed to participate by the Oct. 1 deadline, however, the process could be complicated by lawsuits filed by all of these drugmakers.

All manufacturers of the first 10 prescription drugs selected for Medicare price negotiations agreed to participate by the October 1 deadline. However, the court battle and war of words over the policy are expected to continue before negotiated prices take effect in 2026.

Chiquita Brooks-LaSure, administrator of the Centers for Medicare & Medicaid Services, said this is the first step in making several of the costliest drugs more affordable. “We look forward to engaging with the drug manufacturers of the selected drugs that have decided to participate in the Medicare Drug Price Negotiation Program,” she said. “Our goal is to ensure access to innovative treatments and therapies for people that need them, when they need them. Medicare will negotiate in good faith consistent with the requirements of the law on behalf of people with Medicare.”

The 10 drugs and their manufacturers are:

Even with the participation, however, the process still could be complicated by lawsuits from drugmakers and sharp criticism from Republicans. President Joe Biden noted in a video that the drug manufacturers’ agreeing to participate followed a court decision allowing Medicare price negotiation plans to move forward.

“For many Americans, the cost of one drug is the difference between life and death, dignity and dependence, hope and fear,” he said. “And that’s why we’ll continue to fight to lower health-care costs, and we will not stop until we finish the job.”

However, manufacturers and industry groups have filed multiple lawsuits in federal courts across nation, contending that the program is unconstitutional in various ways.

“We have no choice other than to sign the ‘agreement,’” a Bristol Myers Squibb spokesperson told CNN. “If we did not sign, we’d be required to pay impossibly high penalties unless we withdraw all of our medicines from Medicare and Medicaid. That is not a real choice.”

Related: Drug price negotiations are on: 5 things to know about the impact on the industry

Merck said it was signing the agreement under protest. “While we disagree on both legal and policy grounds with the Inflation Reduction Act’s new program, withdrawing all of the company’s products from Medicare and Medicaid would have devastating consequences for the millions of Americans who rely on our innovative medicines, and it is not tenable for any manufacturer to abandon nearly half of the U.S. prescription drug market,” the company said. “The choice between doing so and weathering the IRA’s massive fines and taxes is no choice at all. As we enter this next phase with the government, we remain focused on challenging the constitutionality of the statute in our ongoing litigation.”

It will take time for the lawsuits to wind their way through the courts. An effort to stop the process before the deadline for the manufacturers to sign the agreements failed last week when a federal court judge in Ohio denied a request by the U.S. Chamber of Commerce to issue a preliminary injunction.