Judge Tosses Boehringer Bid to Block Biden Drug Price Plan

Boehringer Ingelheim’s attempt to block the Medicare Drug Price Negotiation Program was rejected by a federal judge Wednesday, handing another win to the Biden administration in the war of lawsuits challenging his signature health plan.

Chief Judge Michael P. Shea of the US District Court for the District of Connecticut denied all of Boehringer Ingelheim Pharmaceuitcals Inc.'s claims that the Biden administration’s program is unconstitutional.

At issue is whether the signature Inflation Reduction Act plan to lower the costs of the prescription drugs Medicare spends the most on is unconstitutional by forcing the company to agree to a maximum fair price for its drug. Its diabetes drug Jardiance was selected as one of the 10 medicines in the first negotiation round.

The manufacturer argued the program violates the First Amendment prohibition on compelled speech, Fifth Amendment due process and takings clauses, Eighth Amendment excessive fines clause, the Administrative Procedure Act, and the unconstitutional conditions doctrine.

“I find that BI’s participation in Medicare and Medicaid is voluntary, even if BI has a considerable economic incentive to participate,” Shea wrote.

“With all the resources at the federal government’s disposal, private corporations will often have an incentive to participate in federal programs. The Fifth Amendment does not prevent the federal government from placing conditions on participation in those programs,” he added.

The Obama appointee went on in the 47-page opinion to say the drugmaker hasn’t been deprived of its “property interest in its confidential data regarding Jardiance,” because BI was not required to turn over any data until Oct. 2, 2023.

Boehringer “had an option to withdraw from Medicare and Medicaid before that point,” he wrote.

As for the drugmaker’s First Amendment claim, a prime argument of other drugmaker and industry lawsuits challenging the program, Shea wrote the “argument finds no support in precedent.”

“Indeed, the IRA requires BI to communicate in various ways, including, arguably, by signing the Manufacturer Agreement and by making a written counteroffer that must ‘be justified based on [the statutory factors],’” Shea wrote. “But as with ‘typical price regulations,’ the words CMS requires manufacturers to use are just an incidental means to CMS’ goal of regulating drug prices.”

Shea also ruled that even if Boehringer could show irreparable harm, it cannot show certainty of success on the merit, in response to the manufacturer’s Eighth Amendment argument.

“BI cannot meet this demanding standard because its Eighth Amendment claim is novel and, so, far from certain,” Shea wrote. “BI has identified no case in which a court has applied the Excessive Fines Clause to a monetary amount that was not connected to criminal conduct or a criminal proceeding.”

The case is Boehringer Ingelheim Pharmaceuticals, Inc. v. United States Department of Health and Human Services, D. Conn., No. 3:23-cv-01103, opinion 7/3/24.