istockphoto 1285497344 612x612 1

On October 25, 2021, drug manufacturer Boehringer Ingelheim Pharmaceuticals, Inc. filed a lawsuit in the U.S. District Court for the District of Columbia against HHS, alleging that HHS’s policy on contract pharmacies is unlawful.  Boehringer was the seventh drug manufacturer to receive a letter from HRSA stating that restrictions on access to 340B pricing at contract pharmacies has “resulted in overcharges and are in direct violation of the 340B statute.”  Although Boehringer received the letter on October 4th, it is the same letter that was sent to the other six manufacturers on May 17th.  Boehringer’s decision to sue is not surprising given that the other companies in receipt of the May 17th letter have all filed lawsuits in federal court challenging HHS’s contract pharmacy policy.

Boehringer’s complaint alleges that HHS’s contract pharmacy policy and HRSA’s October 4th letter are arbitrary, capricious, and in violation of the Federal Administrative Procedure Act, the 340B statute, and the US Constitution.  Boehringer asks the court to declare that 1) the October 4th letter is unlawful and should be vacated, 2) Boehringer is not required to provide 340B discounts to contract pharmacies, 3) Boehringer’s contract pharmacy policy complies with the 340B statute, and 4) HHS is prohibited from taking any enforcement action against Boehringer through the ADR process and that Boehringer should not be subject to civil monetary penalties.

Similar to the other manufacturer lawsuits, Boehringer alleges that the “exponential increase in use of contract pharmacies … creates serious concerns about the integrity of the 340B program”.  However, nowhere in Boehringer’s complaint does it address the immense amounts of uncompensated or undercompensated care and other safety net services by virtue of 340B savings and revenue, much of which is obtained through contract pharmacy arrangements.

Boehringer is the third manufacturer to file in the DC District Court.  Novartis and United Therapeutics also filed a lawsuit in the same court and the cases were both assigned to Judge Dabney Friedrich.  On October 12, 2021, the DC District Court held a hearing on the consolidated motions brought by United Therapeutics and Novartis.  Kalderos’ lawsuit against HHS was also filed in the DC District Court and assigned to Judge Friedrich.