Insulin and diabetes drug manufacturers want a federal district judge to dismiss 340B-related antitrust changes against them.

Insulin and Diabetes Drug Makers Ask Judge to Dismiss 340B-Related Antitrust Charges

U.S. manufacturers of insulin and diabetes-related treatments asked a federal judge on Friday to dismiss two health centers’ antitrust class action over the companies’ denials of 340B pricing when covered entities use contract pharmacies.

In a Nov. 11 joint motion filed in federal district court in Rochester, N.Y., the companies (Sanofi, Lilly, Novo Nordisk, and AstraZeneca) say that the health centers (Mosaic Health of upstate New York and Central Virginia Health Services) lack standing to sue and offer no direct or circumstantial evidence of conspiracy to restrain trade.

The antitrust lawsuit, they say is “an improper attempt to end-run” around the U.S. Supreme Court’s 2011 ruling that 340B covered entities lack a private right of action to sue manufacturers over alleged illegal charges above 340B ceiling prices. They also asked the court to dismiss the health centers’ claims against them brought under 26 states’ antitrust laws and 48 states’ unjust enrichment laws.

“Plaintiffs are not complaining about anti-competitive conduct that has influenced competitive market prices,” Novo Nordisk argued in a separate motion to dismiss that it filed in addition to the joint motion with the other companies. “They are asserting an unwritten statutory right to force Novo and other manufacturers to deliver drugs purchased at discounted, non-market prices to commercial pharmacies.”

“Whether that theory is viable turns on a proper interpretation of the 340B statute, but importantly cannot be litigated in a private action brought by covered entities, such as Plaintiffs” due to the 2011 Supreme Court decision, Novo Nordisk said. “If there is a violation of the statute, it must be enforced through the regulatory processes that Congress designed. The antitrust laws should not be wielded to create a private remedy under the 340B statute that Congress did not authorize.”

The health centers have until Jan. 7, 2022, to respond to the companies’ motion to dismiss. The companies then have until Feb. 4 to reply.

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