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  • Washington Highlights

    Members of the House, Senate Send Bipartisan Letters Urging Azar to Protect 340B Program


    Jason Kleinman, Senior Legislative Analyst, Govt. Relations

    Members of the House and Senate each sent bipartisan letters this week to Department of Health and Human Services Secretary Alex Azar urging the agency to take immediate action to ensure that drug manufacturers continue to provide safety-net hospitals with discounts on eligible drugs as required under the 340B Drug Pricing Program.

    Nearly 250 members of the House joined a Sept. 14 letter led by Reps. David McKinley (R-WV) and Diana DeGette (D-CO) that highlights recent actions by drug companies to undermine the 340B program. Two manufacturers announced they will limit or restrict 340B pricing based on where the safety net provider elects to have its 340B drugs shipped. Other manufacturers have sent requests to covered entities demanding extensive claims data that goes beyond the scope of the 340B program.

    “The actions of these companies violate the 340B statute and must be rejected. … We urge you to use your authority to address these troubling actions and require these companies to comply with the law,” the letter stated.

    Senators Tammy Baldwin (D-WI), John Thune (R-SD), Debbie Stabenow (D-MI), Rob Portman (R-OH), Shelly Moore Capito (R-WV), and Ben Cardin (D-MD) led a similar letter in the Senate. Their Sept. 17 letter to Sec. Azar, which was signed by 28 senators, states, “To ensure pharmaceutical manufacturers continue to comply with the 340B statute and provide discounts to safety-net providers, we call on HRSA to take appropriate, prompt enforcement action to address violations of the Public Health Service Act.”

    Additionally, House Energy and Commerce Committee Chair Frank Pallone (D-NJ), Health Subcommittee Chair Anna Eshoo (D-CA), and Oversight and Investigations Subcommittee Chair Diana DeGette (D-CO) also sent a letter to Sec. Azar on Sept. 3 to express strong concerns about several drug manufacturers’ actions that threaten to undermine the 340B program.

    “While we recognize many manufacturers have taken issue with the expanded reach of contract pharmacies and have expressed concern about the potential for duplicate discounts, these actions are not oversight or compliance with measures authorized by law, and could represent a failure of manufacturers to meet their requirements under the 340B statute,” according to the letter.

    “As we confront the COVID-19 pandemic, patients are relying on 340B covered entities to go the extra mile to provide care. We look forward to working with you to ensure access to care is not threatened and all participants in the 340B program are fulfilling their obligations under the law,” House leaders concluded.