Amgen Challenges HHS Over 340B Drug Discounts

Amgen has become the latest drugmaker to file a lawsuit against HHS over the federal government’s attempts to force pharma companies to provide 340B drug discounts to contract pharmacies.

At issue is the explosion in the use of contract pharmacies not owned by hospitals covered by the 340B program, which drugmakers claim is leading to duplicate discounts. In exchange for participation in Medicare and Medicaid, the program requires companies to offer discounts ranging from an estimated 25 to 50 percent to hospitals and clinics that treat low-income patients.

In its complaint, Amgen said it limited its 340B drug discount policy in January after “multiple district courts had ruled” that interpretations of the 340B statute were “flawed and inconsistent” and argued that the 340B statute was “silent” on manufacturer obligations to provide 340B-priced drugs to contract pharmacies.

Besides Amgen, more than a dozen drugmakers have either stopped participating in the program or have limited their involvement, including AstraZeneca, Eli Lilly, Novartis, Sanofi, United Therapeutics, Novo Nordisk, Merck, UCB, Pfizer, Boehringer Ingelheim, AbbVie, Bristol Myers Squibb, GSK, Gilead Sciences and Johnson & Johnson.