ASHP Disappointed in 340B Orphan Drug Court Decision

PRESS RELEASE

BETHESDA, MD - ASHP announced today that it is extremely disappointed in the recent court decision by the U.S District Court for the District of Columbia that will exclude all drugs with an “orphan” designation from the 340B Drug Pricing Program for rural and cancer hospitals.

In an October 14 decision, the court struck down an interpretive rule by the Health Resources and Services Administration (HRSA) that allowed rural hospitals and other facilities newly eligible for 340B discounts to use the program to purchase orphan drugs when the product will not be used for the orphan indication.

"This ruling will limit access to critical medications for the sickest patients in our healthcare system,” said Kasey K. Thompson, Pharm.D., M.S., M.B.A., ASHP Vice President of Policy, Planning, and Communications. “ASHP has long maintained that the interpretation by HRSA of the orphan drug provisions of the Affordable Care Act was correct and that rural and cancer hospitals should be able to access orphan drugs under the 340B program when used for non-orphan indications.”

The entities affected by the court decision — rural, cancer, critical-access, and sole community hospitals — treat patients with the most acute and complex medical conditions. Without access to these discounts, participating hospitals may not be able to absorb the cost of providing care to patients who otherwise would not be able to afford it.