Background Image

Statement from the ASBM on Senate HELP Committee 340B Reform Report

April 29, 2025

The Alliance for Safe Biologic Medicines (ASBM) commends Senator Bill Cassidy and the Senate HELP Committee for their new report, “Congress Must Act to Bring Needed Reforms to the 340B Program.” The program is designed to support underserved populations by ensuring access to medicines by allowing qualifying entities to safety-net hospitals, community health centers, and federally qualified health centers (FQHCs) to purchase outpatient drugs at discounted prices and reinvest the savings into expanded care for vulnerable patients. However, over time, the program has deviated from this original mission, often becoming a source of profit for large health systems, contract pharmacies, and third-party administrators instead of vulnerable patients.

Senate HELP Committee investigations have revealed that some large hospital systems, such as Bon Secours Mercy Health and Cleveland Clinic, have generated hundreds of millions of dollars in 340B revenue and used these to fund capital improvements rather than passing these discounts directly to patients. Contract pharmacy arrangements and associated fees have also diverted 340B savings away from patients. 

Michael Reilly, Executive Director of ASBM and former Associate Deputy Secretary of the U.S. Department of Health and Human Services (HHS), emphasized the importance of these reforms, stating:

“The 340B program’s original mission was noble: to expand access to care for vulnerable patient populations. Senator Cassidy’s reforms are long overdue and will help ensure that 340B savings are used as intended — improving patient care, not enriching middlemen”

The Report’s proposed reforms include:

  • Transparency in 340B Revenue Use: Mandates hospitals and clinics to report how savings are spent, ensuring funds are used to lower patient costs or expand services.
  • Clear Patient Eligibility Standards: Establishes a precise definition of a “340B patient,” ensuring discounts are tied to care for truly underserved populations.
  • Regulation of Contract Pharmacy Fees: Investigates and curbs excessive fees by pharmacies and third-party administrators, allowing more savings to benefit patients.
  • Strengthen Oversight: Helps prevent duplicate discounts and diversion, ensuring the 340B program remains sustainable for both manufacturers and patients.
  • Stronger Enforcement Authority for HRSA: Empowers the Health Resources and Services Administration to oversee compliance and penalize abuse effectively. 

ASBM urges Congress to swiftly enact these reforms to restore transparency and accountability and help refocus the 340B program on its core mission: ensuring vulnerable patients can access the medicines they need.

###