The National Association of Community Health Centers (NACHC) strongly urged the U.S. Health and Human Services Secretary Xavier Becerra yesterday “to swiftly impose” fines on drug manufacturers that restrict shipments of 340B-purchased drugs to contract pharmacies and “hold manufacturers accountable for the breach” of their 340B pharmaceutical pricing agreements.
“Pharmaceutical manufacturers have callously and unlawfully chosen to restrict health centers’ access to 340B priced medications,” NACHC Interim President and CEO Rachel Gonzales-Hanson said in a June 16 letter to Becerra. “Health centers continue to experience devastating financial losses as we wait for final decisions in the alternative dispute resolution (ADR) process and ongoing federal court litigation.”
“We strongly encourage HHS to assess and exercise its full authority to hold pharmaceutical manufacturers accountable for violating the 340B statute and, in doing so, to restore health centers’ access to 340B discount pricing,” Gonzales-Hanson said.
NACHC urged HHS to:
- Encourage the Office of Inspector General (OIG) to swiftly impose civil monetary penalties (CMP) on pharmaceutical manufacturers. “OIG needs to move forward with issuing CMPs and taking other necessary actions to enforce the 340B statute,” Gonzales-Hanson told Becerra. “We ask that HHS inquire as to why OIG has not swiftly completed its investigation, determined whether the statute is being violated, and acted as necessary to enforce drug manufacturers’ 340B statute and PPA [pharmaceutical pricing agreement] obligations.”
- Evaluate pharmaceutical manufacturers’ failure to comply with their 340B pricing agreements “HHS has made clear in various federal court litigations that it has determined manufacturers to be in breach of their PPAs,” Gonzales-Hanson said. “NACHC encourages HHS to hold manufacturers accountable for the breach of their PPAs.”
Reps. Abigail D. Spanberger (D-Va.), Cindy Axne (D-Iowa), David McKinley (R-W.Va.), Doris Matsui (D-Calif.), John Katko (R-N.Y.), and Dusty Johnson (R-S.D.) are urging fellow House members to sign a letter to Becerra, HHS Inspector General Christi Grimm, and Health Resources and Services Administration Administrator Carole Johnson urging HHS and OIG “to impose civil monetary penalties against all drug manufacturers who have unlawfully overcharged safety net health care providers.”
In a May 2 letter, Senate Finance Committee ranking Republican Chuck Grassley (Iowa) asked Grimm if OIG “plans to take enforcement action against these drug manufacturers.”