AbbVie filed a lawsuit on April 8, 2026, challenging the Health Resources and Services Administration's (HRSA) 1996 guidance on the 340B drug discount program's patient definition as overly broad and outdated.1257
The suit argues that the current 'established relationship' definition allows abuse by including patients with minimal or past interactions, contrary to Congress's intent.256
AbbVie proposes limiting eligible patients to those prescribed drugs due to care from the provider within the prior 12 months, with the provider actively managing the condition.2
The lawsuit targets federal health agencies, aiming to establish a clearer patient definition to curb perceived rampant abuse in the program.17
This action continues ongoing 340B disputes between pharma companies and providers, following prior court rulings favoring broad definitions.2
Sources:
1. https://www.fiercepharma.com/pharma/abbvie-challenges-outdated-340b-drug-discount-program-guidance-new-suit
2. https://www.axios.com/2026/04/08/abbvie-drug-discount-patient-lawsuit
5. https://www.law360.com/articles/2463088
6. https://insidehealthpolicy.com/inside-drug-pricing-daily-news/abbvie-lawsuit-claims-too-many-patients-get-340b-discount-drugs
7. https://news.abbvie.com/2026-04-08-AbbVie-moves-to-close-loopholes-and-strengthen-accountability-in-340B-program