Law firm Latham & Watkins says HRSA is impeding its access to records it needs to represent United Therapeutics in its 340B contract pharmacy lawsuit against HRSA and HHS. | Shutterstock

Law Firm Sues HRSA Over FOIA Request for 340B Contract Pharmacy Documents

The law firm representing United Therapeutics (UT) in its 340B contract pharmacy lawsuit against the federal government has filed its own related lawsuit against the government.

In a July 13 complaint filed in federal district court in Washington, D.C., Latham & Watkins alleges that the U.S. Health and Human Services Department (HHS) and the U.S. Health Resources and Services Administration (HRSA) are impeding its access to government records it “urgently needs” to represent UT in the manufacturer’s contract pharmacy lawsuit.

On June 9, Latham submitted Freedom of Information Act (FOIA) requests to HRSA for a wide-ranging set of documents:

  • all complaints HRSA got from covered entities about inability to buy UT products at or below the 340B ceiling price
  • documents reflecting HRSA’s analysis of such complaints
  • any other covered entity communications with HRSA regarding UT’s participation in 340B
  • all documents related to  HRSA’s analysis of UT’s 340B contract pharmacy policies
  • all documents related to the formulation of HRSA’s May 17 and May 28 340B violation letters to UT
  • all documents since HRSA issued its March 2010 multiple contract pharmacy guidance in which entities using contract pharmacies discovered drug diversion or duplicate discounting; the remedial actions they took; and any analysis or response from HRSA
  • all documents since HRSA issued its multiple contract pharmacy guidance in which entities, in accordance with the guidance, certified their compliance “with various regulatory requirements”; and any analysis or response from HRSA.

On the same day, Latham submitted a FOIA request to HHS for all documents related to the formulation of the HHS general counsel’s Dec. 30 advisory opinion that the 340B statute requires manufacturers to offer covered entities 340B pricing on covered drugs without regard to where or how the drugs are dispensed.

“Neither HHS nor HRSA has made a determination on Latham’s FOIA requests within the statutorily mandated 20 working days for such determination,” the law firm’s complaint says. “As a result, HHS and HRSA are impeding Latham’s access to these important records.”

Latham has asked the court to declare that HHS and HRSA violated FOIA, and to order them

“to provide Latham with legally compliant responses to its request.”

HRSA declined to comment on Latham’s suit, citing its policy of not comment on pending litigation or active disputes.

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