House and Senate leaders push HRSA to finalize 340B regulations on drug pricing, penalties

Patty Murray and Lamar Alexander during committee hearing
Sens. Lamar Alexander, R-Tenn., and Patty Murray, D-Wash., are among those asking HRSA to finalize 340B rules. (Senate HELP Committee)

A group of lawmakers from both sides of the aisle is asking the Health Resources and Services Administration (HRSA) to push forward with new rules around 340B drug pricing.

Specifically, four members of the House and Senate have asked the agency to implement a binding Administrative Dispute Resolution (ADR) process to resolve compliance disputes, impose civil monetary penalties against manufacturers or knowingly overcharge the 340B program and issue “precisely defined standards of methodology” for calculating 340B ceiling prices.

The letter (PDF), signed by Reps. Greg Walden, R-Ore. and Frank Pallone Jr., D-N.J., and Sens. Patty Murray, D-Wash., and Lamar Alexander, R-Tenn., urged Krista Pedley, director of the Office of Pharmacy Affairs at HRSA, to issue the specific regulations despite several court decisions that limited the agency’s rulemaking authority.


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“Given the important role the 340B program plays in our nation’s healthcare safety net, it is critical that program rules be clear and consistent for all stakeholders,” they wrote. “Unfortunately, the agency has faced significant impediments to appropriate oversight and enforcement given recent judicial decisions that, in effect, left the agency without broad rulemaking authority.”

RELATED: HHS delays 340B drug price ceilings and penalties for the fifth time

The Department of Health and Human Services (HHS) has repeatedly delayed a rule that would set ceiling prices and impose penalties for drugmakers that overcharge the program. Watchdog agencies have said the 340B program is plagued by a lack of transparency.

The lawmakers said they “remain concerned that the agency is not using its existing authorities.” For its part, HRSA has said it needs Congress to consider legislation that would expand the agency’s rulemaking authority.

But the lawmakers said HRSA doesn’t need their help.

“We believe HRSA action to issue or implement final regulations in an open and transparent process, in collaboration with all relevant stakeholders, could clarify and update program requirements in pursuit of strengthening access to necessary care and proper administration of the program,” they wrote.

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