AstraZeneca, Sanofi, Eli Lilly sue HHS over 340B opinion

Eli Lilly, Sanofi and AstraZeneca have all filed lawsuits asking courts to reverse an advisory opinion released by HHS stating that 340B discounts apply to contract pharmacies, Bloomberg Law reported.

The drugmakers argue the advisory opinion, which HHS released Dec. 30, is unlawful and requires them to honor a practice that isn't covered under the 340B statute. Advisory opinions don't carry the force of a law, but they guide how HHS enforces the program

The drug companies are worried that the alternative dispute resolution board will rely on the opinion when making decisions, according to Bloomberg Law. The Health Resources & Services Administration created the dispute resolution board in early December, designed to settle disputes between 340B hospitals and drugmakers. Because the panel consists of HHS representatives, it will "treat the advisory opinion as binding in any ADR proceeding, almost certainly find that Sanofi’s integrity initiative violates Section 340B as interpreted by HHS, and potentially impose crippling sanctions," Sanofi said in its lawsuit

AstraZeneca said in its lawsuit that agreements between 340B hospitals and contract pharmacies have "transformed the 340B program from one intended to assist vulnerable patients into a multibillion dollar arbitrage scheme that benefits national for-profit pharmacy chains and other for-profit intermediaries," according to Bloomberg Law. 

Eli Lilly argued in its lawsuit that: "Nothing in the statute allows, let alone mandates, the use of contract pharmacies or that manufacturers respect an unlimited number of covered entity–contract pharmacy relationships. In fact, the opposite is true."

Read the full article here.

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