Skip to Content

Filter by:

Washington Highlights

HRSA Stands by 340B Orphan Drug Exclusion

June 20, 2014— The Health Resources and Services Administration (HRSA) has posted on its website its decision to “stand by” its interpretation of the orphan drug exclusion established under a July 23, 2013, final rule. The HRSA decision follows a May 23, 2014, U.S. District Court ruling that the U.S. Department of Health and Human Services (HHS) lacked statutory authority to engage in such rulemaking.

Arguing that “the Court did not invalidate HRSA’s interpretation of the statute,” HHS and HRSA will continue to allow “340B covered entities affected by the orphan drug exclusion to purchase orphan drugs at 340B prices” when those drugs are used “for any indication other than treating the rare disease or condition for which the drug received an orphan designation.” HRSA will continue to post updated “Orphan Drug Designation Lists” and the “Orphan Selection File” so that the appropriate stakeholders may comply with the policy.

Neither HHS nor HRSA have indicated how recent actions related to the orphan drug exclusion might affect the timing or content of a much-anticipated proposed regulation targeting program integrity in the 340B Drug Pricing Program.


Christiane Mitchell
Senior Director Health Care Affairs
Telephone: 202-828-0461


envelope on a green background

Subscribe to Washington Highlights

RSS icon

Subscribe to RSS

Washington Highlights, a weekly electronic newsletter, features brief updates on the latest legislative and regulatory activities affecting medical schools and teaching hospitals.

Past Issues

For More Information

Jason Kleinman
Sr. Legislative Analyst, Govt. Relations
Telephone: 202-903-0806