The AAMC sent a Feb. 4 letter to Health Resources and Services Administration (HRSA) Administrator Thomas Engels expressing the association’s concerns with new 340B Drug Pricing Program data collection requirements (PDF) imposed by two drug manufacturers. Eli Lilly began requiring 340B covered entities to submit claims-level data for all 340B drugs, including those dispensed through in-house pharmacies, starting Feb. 1. Exelixis imposed a similar requirement that took effect Oct. 1, 2025.
In the letter, the AAMC stressed that data collection requirements are onerous, unlawful under the 340B statute, and usurp HRSA’s oversight responsibilities. The AAMC asked HRSA to communicate to drug manufacturers that their actions violate the 340B statute and to use the enforcement mechanisms at the agency’s disposal to follow through if manufacturers fail to comply.
- Washington Highlights