HHS to move forward allowing 340B orphan drug discounts
AHA News Now
Jun 18, 2014
The Department of Health and Human Services and its Health Resources and Services Administration will continue to allow certain hospitals to purchase “orphan drugs” through the 340B Drug Pricing Program when the drugs are not used to treat the rare conditions for which the orphan drug designation was given, HRSA said on its website today. While a recent federal court decision “vacated the orphan drug regulation on the grounds that HHS lacks the statutory authority to engage in such rulemaking…the Court did not invalidate HRSA’s interpretation of the statute,” the agency said. “HHS/HRSA continues to stand by the interpretation described in its published final rule.” HRSA also posted updated orphan drug designation lists and an orphan drug selection file to assist 340B stakeholders in complying with HRSA's policy. The orphan drug exclusion policy applies to critical access hospitals, sole community providers, rural referral centers and free-standing cancer hospitals. AHA filed a friend-of-the-court brief supporting HHS in the lawsuit, which was brought by the Pharmaceutical Research and Manufacturers of America.