Drug manufacturer Boehringer Ingelheim on Tuesday disputed a federal health agency’s finding a day earlier that BI’s denials of 340B discounts on its drugs when hospitals use contract pharmacies are illegal.
“Boehringer Ingelheim Pharmaceuticals, Inc. is committed to ensuring that its medicines are accessible and affordable to all patients, including through the 340B program,” BI Senior Vice President, Market Access Chris Marsh said in a statement. “Our carefully tailored contract pharmacy policy is fully compliant with the 340B statute and is intended to help ensure that 340B discounts benefit the patients of covered entities.”
The U.S. Health Resources and Services Administration (HRSA) on Monday notified BI that its 340B pricing actions “have resulted in overcharges and are in direct violation of the 340B statute.”
“Nothing in the 340B statute grants a manufacturer the right to place conditions on its fulfillment of its statutory obligation to offer 340B pricing on covered outpatient drugs purchased by covered entities,” HRSA said. It said it “has made plain” since issuing 340B contract pharmacy program guidance in 1996 “that the 340B statute requires manufacturers to honor such purchases regardless of the dispensing mechanism.”
HRSA told BI it “must immediately begin offering its covered outpatient drugs at the 340B ceiling price to covered entities through their contract pharmacy arrangements” and “work with all of its distribution/wholesale partners to ensure all impacted covered entities are contacted and efforts are made to pursue mutually agreed upon refund arrangements.” Failure to comply could result in civil monetary penalties of up to $5,883 per each instance of overcharging, HRSA said. It gave the company until Oct. 18 to share its compliance plan.
BI is the eighth drug manufacturer to impose restrictions on 340B pricing when 340B covered entities use contract pharmacies. HRSA so far has told seven of the eight their actions are illegal. It is widely expected to tell the eighth, Merck, that its policy is illegal, too.
BI and Merck are the latest to impose restrictions. In September, HRSA referred the first six companies to impose restrictions to the U.S. Health and Human Services Department Office of Inspector General for possible imposition of civil monetary penalties. The six companies— AstraZeneca, Lilly, Novartis, Novo Nordisk, Sanofi, and United Therapeutics—are challenging HRSA’s findings in federal courts.
The American Hospital Association (AHA) yesterday applauded HRSA for telling BI it was breaking the law and needed to stop or risk punishment.
“The AHA commends HRSA for responding to our concerns and taking action against Boehringer Ingelheim by ordering the company to comply with federal requirements and stop skirting the law by limiting the distribution of 340B drugs through community pharmacies,” an AHA spokesperson said.