ASHP disagrees with orphan drug ruling

The American Society of Health-System Pharmacists (ASHP) said Friday it is disappointed with the recent decision of the U.S District Court for the District of Columbia that will omit all drugs with an “orphan” designation from the 340B Drug Pricing Program for rural and cancer hospitals.

“This ruling will limit access to critical medications for the sickest patients in our health care system,” ASHP Vice President of Policy, Planning and Communications Kasey Thompson said. “ASHP has long maintained that the interpretation by HRSA ( Health Resources and Services Administration) 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 nonorphan indications.”

The court denied an interpretive rule by HRSA allowing 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.

Rural, cancer, critical-access and sole community hospitals are the parties mainly affected by the court decision. Without access to these drug discounts, participating hospitals may not be able to pay the cost of providing care to patients who otherwise would not be able to afford it.