340B Health responds to court ruling on orphan drugs

340B Health said Oct. 14 it is disappointed with a recent federal district court ruling that will drastically raise the cost of orphan drugs for rural and cancer hospitals and their patients.

"This is a major setback for rural hospitals who are already struggling to keep their doors open,"  340B Health President and CEO Ted Slafsky said.

The court denied guidance that was issued last year by the Health Resources and Services Administration (HRSA) to apply a key provision of the 340B drug discount program. The court said it found the guidance “contrary to the plain language of the statute.”

The proposed guidance enabled rural and cancer hospitals participating in 340B to buy some orphan drugs, high-cost drugs that can be used to treat rare diseases, at discounted prices when a hospital uses the drugs to treat common conditions. Many of these drugs can cost patients up to $300,000 per year, and without access to 340B discounts, hospitals will struggle to meet the needs of their patients.

340B Health was a supporter of HRSA’s guidance and found the guidance to be a sound enactment of the 340B law’s orphan drug exclusion.

340B Health is a nonprofit association of more than 1,000 hospitals that take part in the 340B drug pricing program.