Today, the Health Resources and Services Administration (HRSA), which oversees the 340B Drug Pricing Program, directed six drug manufacturers to comply with 340B pricing requirements or risk financial penalties. HRSA took the action in response to recent requests by ASHP and our partner organizations to take enforcement action against drug manufacturers that fail to comply with 340B program requirements. HRSA cited the manufacturers for program violations, including imposing limits on the availability of 340B discounts, refusing to offer the 340B ceiling prices on drugs dispensed through contract pharmacies, and requiring specific data submission and/or the use of certain reporting platforms.
In letters to AstraZeneca, Eli Lilly, Novartis, Novo Nordisk, Sanofi, and United Therapeutics, HRSA informed the manufacturers that their policies restricting 340B pricing for contract pharmacies directly violate the 340B statute by resulting in overcharges. HRSA directed the manufacturers to immediately provide the 340B price to covered entities, including those using contract pharmacies to distribute medications, and to refund previous overcharges to 340B covered entities. Additionally, HRSA cautioned that continued violation of the 340B statute could result in imposition of civil monetary penalties on the manufacturers.
“HRSA’s aggressive action is necessary to stem manufacturer efforts to illegally undercut the 340B program,” said Tom Kraus, ASHP vice president of government relations. “HRSA’s clear directive to manufacturers to comply with the program or face financial penalties is a major step toward safeguarding the 340B program and the vulnerable populations it benefits.”
ASHP and five national hospital organizations have engaged in litigation to require the government to enforce 340B program requirements. ASHP will continue to keep our members informed on the ongoing 340B litigation and our aggressive advocacy on this critical program for our members and the patients they serve.