Trio of Drugmakers File Lawsuits Against HHS Over 340B Discounts

AstraZeneca (AZ), Sanofi and Eli Lilly have each filed lawsuits against HHS, arguing the federal government can’t force them to provide 340B drug discounts to contract pharmacies.

Drugmakers have long argued the 340B drug program’s expansion to include contract pharmacies not owned by covered entity hospitals creates the potential for duplicate discounts under the program.

In separate complaints filed in federal courts in Delaware, New Jersey and Indiana last week, AZ, Sanofi and Eli Lilly say HHS failed to provide notice before issuing a Dec. 30 advisory ruling (DID, Jan. 6) and contend that the federal government doesn’t legally require them to provide discounts to contract pharmacies. They also claim that the 340B program’s expansion in recent year goes against its stated goal of helping low-income citizens, since any eligible patient may receive the discounted price at a contract pharmacy.

A coalition of hospital groups filed a separate complaint in federal district court last month, alleging the department failed to ensure that drugmakers offered the 340B discounts (DID, Dec. 15, 2020).

Also in December, more than two dozen state attorneys generals called on HHS to fine drugmakers who refuse to offer the 340B discounts to contract pharmacies (DID, Dec. 16, 2020).

Hoping to protect the program, HHS has created a dispute procedure for hospitals that claim drugmakers are overcharging them for medications, while also allowing drugmakers to appeal if they believe a hospital received a duplicate discount. But the move has failed to appease either side.

In early January, HHS General Counsel Robert Charrow said manufacturers were trying to bypass the 340B program’s dispute resolution procedures.

HHS declined to comment on the ongoing litigation.

Read the AZ lawsuit here: www.fdanews.com/01-15-21-AZLawsuit.pdf.

Read the Sanofi lawsuit here: www.fdanews.com/01-15-21-SanofiLawsuit.pdf.

Read the Eli Lilly lawsuit here: www.fdanews.com/01-15-21-EliLillyLawsuit.pdf. ― Jason Scott