Congressional Letters to Secretary Azar to Object to Manufacturer Actions

15 Sep 2020

Thanks to efforts by RWC-340B members and other covered entity advocates, 243 members of the House of Representatives (174 Democrat and 69 Republican members) signed a bipartisan letter (“Letter”) objecting to recent manufacturer actions to dismantle 340B contract pharmacy arrangements.  Many thanks to those RWC-340B members that contacted their House members to sign the letter.  Of note, the letter:

  • specifically mentions Ryan White clinics as a covered entity group that the members are seeking to protect;
  • states that the recent manufacturer actions that challenge contract pharmacy arrangements “violate the 340B statute and must be rejected”;
  • notes that “failure to act will serve as an invitation to other manufacturers to follow suit, leading to a wholesale increase in prescription drug costs for our safety-net providers during a public health emergency”; and
  • calls on Secretary Azar to use his authority “to address these troubling actions and require these companies to comply with the law.”

The sign-on Letter follows a letter sent by three chairs of the House Energy and Commerce. Chairman Frank Pallone (D-NJ), full committee chair, was joined by Health subcommittee chair, Anna Eshoo (D-CA), and Oversight subcommittee chair, Diana DeGette (D-CO), in sending a letter to Secretary Azar on September 3, 2020 outlining the adverse impact of the manufacturer actions on the 340B community and calling for Secretary Azar to take action against the manufacturers.  In pertinent part, the E&C Letter:

  • expresses “strong concerns” about actions that “threaten to undermine the 340B program”;
  • notes that 340B savings “do not cost the American taxpayer a single dollar”;
  • reiterates the importance of safety-net providers during the COVID-19 crisis and the role of the 340B program in protecting those providers;
  • explains that recent manufacturer actions place arbitrary limits on the number of contract pharmacies, cut off delivery of 340B drugs to contract pharmacies, in some instances, and impose burdensome data reporting requirements on covered entities;
  • explains that the manufacturer actions violate the 340B statute, which HRSA has the authority to enforce through audits and civil monetary penalties; and
  • warns that the manufacturers’ actions and HRSA’s lack of a response “set(s) us on a treacherous path where program participants might disregard any or all of their legal obligations” under the 340B program.

The Powers 340B Team will continue to monitor manufacturer actions and the advocacy efforts in response to those actions.

Category: RWC-340B

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