By Overturning 340B Orphan Drug Rule, Court Could Stifle Future HRSA Rulemaking

A Friday court ruling that HRSA overstepped its authority by issuing regulations stating orphan drugs used for off-label treatments are subject to 340B program discounts calls into question the agency's authority to issue a long-awaited "mega-reg" laying out the parameters for the broader drug discount program, some industry sources tell Inside Health Policy. In a win for the drug industry, a U.S. District judge on May 23 overturned HRSA's regulation -- which means that any orphan drug regardless of how it is used is now exempt from the 340B discounts – on the grounds that Congress didn't give HRSA authority to clarify an ACA provision that exempts orphan drugs from 340B expansion facilities.

Read More: By Overturning 340B Orphan Drug Rule, Court Could Stifle Future HRSA Rulemaking


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