340B Health’s Statement on Orphan Drug Court Decision
340B Health is deeply disappointed with a federal district court ruling today that will significantly raise the cost of orphan drugs for rural and cancer hospitals and their patients. The court struck down guidance issued last year by the Health Resources and Services Administration (HRSA) to implement a key provision of the 340B drug discount program, finding the guidance “contrary to the plain language of the statute.” The guidance allowed rural and cancer hospitals participating in 340B to purchase certain high-cost drugs that can be used to treat rare diseases at discounted prices when a hospital uses the drugs to treat common conditions instead of a rare condition. 340B Health supported HRSA’s guidance as a reasonable implementation of the 340B law’s orphan drug exclusion. Many of these drugs can cost patients up to $300,000 per year or more, and without access to 340B discounts, these hospitals will struggle to meet the needs of their vulnerable patients.
“This is a major setback for rural hospitals who are already struggling to keep their doors open,” said Ted Slafsky, 340B Health’s President and Chief Executive Officer. 340B Health is an association of over 1000 hospitals that participate in the 340B program.