Eli Lilly and AstraZeneca are the latest drug makers to disclose they have received a subpoena from the Vermont attorney general’s office related to their denials of 340B ceiling prices on drugs shipped to contract pharmacies.
Lilly and AstraZeneca both disclosed the subpoenas on Friday, in their first quarter financial reports for 2021. Novartis made a similar disclosure earlier last week in its Q1 financial summary. Sanofi disclosed in March, in its 2020 annual financial report, that it got a subpoena from Vermont Attorney General T.J. Donovan (D) about its participation in the 340B program.
The four drug manufacturers are among the six that either have stopped virtually all 340B pricing on drugs dispensed by contract pharmacies, or require covered entities to turn over their 340B contract pharmacy claims data to keep getting such pricing. Novo Nordisk and United Therapeutics are the other two. Both release their Q1 2021 financial reports on Wednesday.
Last December, Donovan was one of 29 state attorneys general to sign a bipartisan letter to then U.S. Health and Human Services Secretary Alex Azar asking him “to address drug manufacturers’ unlawful refusal to provide critical drug discounts to covered entities.”
Also that month, then HHS General Counsel Robert Charrow released a legal advisory opinion stating that the 340B statute requires drug manufacturers to offer their products for sale at or below the 340B ceiling price without regard to how covered entities choose to distribute the drugs. HHS, however, has not initiated enforcement proceedings against any of the six manufacturers that have ended or imposed restrictions on 340B contract pharmacy drugs.
Lilly, Sanofi, Astra Zeneca, and Novo Nordisk are suing in federal court to have the HHS advisory opinion declared illegal, unconstitutional, or both. Lilly and Sanofi also seek to have HHS’s 340B administrative dispute resolution (ADR) regulations struck down, as does industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA) in its own suit against HHS. Covered entities and entity associations have filed 340B ADR petitions against Lilly, Sanofi, and AstraZeneca.