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...