22 U.S. Senate Democrats Want Answers from PhRMA About its Members’ 340B Actions
Twenty-two Democratic U.S. senators asked Pharmaceutical Research and Manufacturers of America (PhRMA) today to inform them by no later than Sept. 29 “regarding steps being taken by the industry to end denials of 340B pricing for drugs dispensed through contract pharmacies and demands for contract pharmacy claims data.”
Drug manufacturers’ recent refusals “to provide 340B pricing for use in contract pharmacies are likely a violation of the law,” the lawmakers wrote Sept. 15 to PhRMA President and CEO Stephen Ubl. Manufacturers’ related demands for 340B covered entities’ claims data, and denials of 340B pricing for drugs dispensed through contract pharmacies if entities fail to provide the data, “are also not tied to 340B compliance obligations,” the senators wrote.
“By improperly limiting access to 340B drugs, manufacturers will sever a lifeline to treatment for those who are overwhelmingly underserved, low-income, and vulnerable,” the senators told Ubl. “The pharmaceutical industry’s recent actions are particularly troubling and detrimental to the goals of the 340B program.”
The Democratic senators’ letter cites reporting by 340B Report and other news organizations on manufacturers’ recent 340B actions.
The letter’s signers include Sens. Patty Murray (D-Wash.), the ranking Democrat on the Health, Education, Labor, and Pensions Committee, which has primary jurisdiction over 340B, and Ron Wyden (D-Ore.), the ranking Democrat on the Finance Committee, which has primary jurisdiction over Medicare and Medicaid. Murray also is the ranking Democrat on the Appropriations Labor, Health and Human Services, and Education Subcommittee, which funds the U.S. Department of Health and Human Services (HHS).
A PhRMA spokesperson said that while the trade association “supports the original intent of the 340B program, we are concerned by the mounting evidence showing the program has strayed off course and is not helping needy patients”
“Contract pharmacy arrangements were born out of guidance issued by the Health Resources and Services Administration, despite contract pharmacies not being mentioned in the 340B law or in any regulations,” the spokesperson continued. “We agree with this administration’s recent statements regarding the rule of law and status of agency guidance. Unlike laws and regulations, agency guidance cannot impose any binding requirements on the public and lack the force and effect of law.”