FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Hospital Groups Sue HHS in Fight for 340B Transparency

Sept. 17, 2018
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Seven hospital organizations sued HHS Tuesday to try to force it to impose a final rule on 340B drug pricing transparency that’s been pending for nearly two years. The complaint filed in the U.S. District Court for the District of Columbia — by the American Hospital Association, the Association of American Medical Colleges, America’s Essential Hospitals, 340B Health and three hospital systems — asks the court to order the department to make the rule effective in 30 days.

“As prescription drug prices continue to skyrocket, the 340B program is as crucial as ever in helping hospitals and health systems provide access to health care services for vulnerable patients and communities,” said Rick Pollack, AHA’s president and CEO. “Our lawsuit will ensure that drug companies provide the transparency and accuracy that the government has found lacking and hold price gouging drug companies accountable.”

HHS has delayed the effective date of the rule five times, most recently on June 5 when it pushed it back another year to July 1, 2019. The rule requires drug companies to release ceiling prices for 340B outpatient drugs, and is designed to ensure that drug companies provide federally-required prescription drug discounts to hospitals serving vulnerable communities.

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