PhRMA Petition to HHS for Rulemaking Regarding an Administrative Dispute Resolution Process for the 340B Drug Pricing Program

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The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovative biopharmaceutical research companies, which are laser focused on developing innovative medicines that transform lives and create a healthier world. Together, we are fighting for solutions to ensure patients can access and afford medicines that prevent, treat and cure disease. Over the last decade, PhRMA member companies have invested more than $850 billion in the search for new treatments and cures, and they support nearly five million jobs in the United States.

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PhRMA petitioned the Secretary of the Department of Health and Human Services and the Administrator of the Health Resources and Services Administration (HRSA), as well as the Director of HRSA’s Office of Pharmacy Affairs, to issue a new proposed rule establishing an administrative dispute-resolution (ADR) procedure for participants in the 340B Drug Pricing Program. PhRMA supports the goal of the 340B program, which is to make prescription medicines more accessible to uninsured or vulnerable patients, but there is significant new evidence that the 340B program is plagued by abuses that are undermining that goal and HRSA has been unwilling to hold covered entities accountable for those abuses. As part of this petition, PhRMA reiterated its prior requests that HRSA include a precise definition of “patient” as well as practical audit procedures. Both elements are essential to an efficient ADR process, which is in turn critical to maintaining the integrity of the 340B program and ensuring that the program achieves its intended purpose.

PhRMA Petition to HHS for Rulemaking Regarding an Administrative Dispute Resolution Process for the 340B Drug Pricing Program image

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