The AAMC sent a letter to Health Resources and Services Administration (HRSA) Administrator Carole Johnson (PDF), outlining the association’s concerns with 340B rebate models proposed by four drug manufacturers and thanking the agency for its enforcement against drug manufacturers, on Dec. 16. Since August, four drug manufacturers have announced that they plan to provide 340B pricing as retrospective rebates instead of upfront discounts. In the letter, the AAMC stressed that the proposed rebate models are unlawful under the 340B statute, usurp HRSA’s oversight responsibilities, and are both financially and operationally disruptive to 340B hospitals.
Separately, drug manufacturer Sanofi, which had proposed a rebate model that would go into effect Jan. 6, 2025, announced that it would pause implementation of its proposed rebate model while it seeks legal recourse in a lawsuit filed in federal district court (PDF). Sanofi’s decision to pause its proposed rebate model and sue HRSA comes in response to a letter from HRSA (PDF), warning that Sanofi could face revocation of its Pharmaceutical Pricing Agreement and potential civil monetary penalties for overcharging for 340B drugs.
- Washington Highlights