U.S. Senate Appropriations Committee room
The U.S. Senate Appropriations Committee wants a report from HRSA "on actions taken to safeguard covered entities’ lawful access to discounted drugs.”

Senate Panel Wants HRSA to Tell How It Has Responded to Drug Makers’ 340B Pricing Denials

The U.S. Senate Appropriations Committee wants federal healthcare officials to tell it what they have done about drug manufacturers’ denials of 340B pricing when covered entities use contract pharmacies.

The committee included the directive to the U.S. Health Resources and Services Administration (HRSA) in an explanatory statement that accompanies its draft spending bill for labor, health and human services, and education programs for the fiscal year that starts Oct. 1. Committee chair Patrick Leahy (D-Vt.) released the bill and statement on July 28. The panel has not yet scheduled a hearing to mark up the bill.

“The 340B program is a critical lifeline to many of its program participants, including FQHCs, FQHC Look-Alikes, children’s hospitals, Ryan White HIV/AIDS clinics, and other safety-net hospitals and providers,” the explanatory statement says. “These covered entities are model stewards of the program and reinvest 340B savings to ‘stretch scarce Federal resources as far as possible, reaching more eligible patients and providing more comprehensive services,’ as Congress intended.”

“The Committee is concerned that manufacturers continue to deny 340B pricing for drugs purchased by covered entities for use in contract pharmacies,” the statement continues. “The Committee supports HRSA’s continued use of its authorities and any available measures, including the imposition of civil penalties, as appropriate, to hold those drug manufacturers in violation of the law directly accountable. The Committee directs HRSA to provide a report no later than 120 days after enactment of this act on actions taken to safeguard covered entities’ lawful access to discounted drugs.”

The committee proposes giving HRSA’s Office of Pharmacy Affairs $12.2 million for FY 2023, $1 million more than the current level but $1 million less than the House Appropriation Committee wants. The Biden administration asked for $17 million for OPA in March.

The House committee also expressed concerns about the growing number of drug manufacturers “that curtail the use of 340B drugs in contract pharmacies.” It encouraged HRSA to use “any available measures,” including imposing civil monetary penalties, “to hold those drug manufacturers in violation of the law directly accountable.”

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