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in 340B Health News Releases

WASHINGTON, D.C., JULY 18, 2022— On Friday, a bipartisan group of members of the U.S. House of Representatives called on the administration to pursue all available enforcement actions against drug companies that are breaking federal law by restricting 340B drug pricing program discounts. These enforcement actions should include steep financial fines on companies that are refusing to restore the discounted pricing required under federal law, the lawmakers state.

A group of 181 House members from both political parties sent a letter urging action to Health and Human Services Secretary Xavier Becerra and other senior administration officials. The letter asks the HHS Office of Inspector General (OIG) to conclude its review of seven drug companies that have been referred to it for continued refusals to come into compliance with federal law on 340B discounts. The law authorizes OIG to impose civil monetary penalties of up to more than $6,000 per drug claim on companies that are “knowingly and intentionally” overcharging 340B providers, and the lawmakers said those fines should start taking effect as soon as possible.

The House letter also urges HHS to pursue immediate enforcement action against 11 additional drug companies that have imposed restrictions or conditions on 340B pricing. Those companies either have not yet received notification from the department that they are in violation of federal law or have received such a notice but have not yet been referred to OIG for possible fines.

“These actions are essential to bringing manufacturers back into compliance with their responsibilities under the statute and will deter other manufacturers from pursuing similar unlawful courses of action,” the House letter to HHS states. “Every day that drug manufacturers violate their obligation to provide these discounted drugs, vulnerable communities, federal grantees, and safety net health care providers are deprived of resources Congress intended to provide.”

Reps. Abigail Spanberger (D-Va.) and David McKinley (R-W.V.) spearheaded the congressional effort, as they did for two similar 340B letters in 2021 and 2020.

“We thank all the members of Congress who are part of this bipartisan call for strong and swift enforcement actions against the drug companies that are refusing to restore required 340B discounts to hospitals,” said 340B Health President and CEO Maureen Testoni. “HHS should impose steep financial penalties on all the companies that are ignoring their legal commitments to the health care safety net. This unlawful behavior is harming patient care, and it must stop.”

Eighteen drug companies have imposed or announced restrictions on 340B pricing to safety-net hospitals for drugs dispensed at community and specialty pharmacies. They are AbbVie, Amgen, AstraZeneca, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Exelixis, Gilead, GlaxoSmithKline, Johnson & Johnson, Merck, Novartis, Novo Nordisk, Pfizer, Sanofi, UCB, and United Therapeutics.

Contact: Richard Sorian at richard.sorian@340bhealth.org or 202-536-2285.