Third Circuit Court of Appeals Rules in Favor of Drugmakers in 340B Contract Pharmacy Case

The United States Court of Appeals for the Third Circuit ruled yesterday in favor of Sanofi, Novo Nordisk, and AstraZeneca in a case regarding 340B contract pharmacies. The drugmakers sued the Department of Health and Human Services (HHS) following attempts by the Health Resources and Services Administration to enforce requirements that the manufacturers honor 340B contract pharmacy arrangements.

Similar cases are pending in two other appellate courts in the District of Columbia and Seventh Circuit. Should those courts find in HHS’s favor, the circuit split would have to be resolved by appeal to the U.S. Supreme Court. At present, this means that the contract pharmacy issue has not been fully decided.

“We are disappointed in the Third Circuit decision, but we believe that the other courts will side with HHS and protect the expanded access provided by contract pharmacy agreements,” said Tom Kraus, ASHP vice president of government relations. “In the interim, we will continue to push back aggressively against manufacturer attempts to unlawfully limit the 340B Drug Pricing Program.”

ASHP remains committed to safeguarding the 340B program. ASHP filed an amicus brief supporting HHS in this case, as well as a separate case brought by Eli Lilly against HHS over the 340B program. In addition to litigation efforts, ASHP and our partners undertook a joint national advocacy effort to safeguard the 340B program, including a digital campaign opposing pharmaceutical manufacturers’ actions that threaten to undermine the program. ASHP also mobilized our members to write to their federal legislators urging them to protect the program.

ASHP will continue to keep our members informed regarding ongoing 340B litigation and our aggressive advocacy efforts to safeguard this critical program for our members and the patients they serve.