On Aug. 27, the DC federal district court issued an order requiring the Pharmaceutical Research and Manufacturers of America (PhRMA) to file a new lawsuit if the association wants to challenge the Office of Pharmacy Affairs’ (OPA’s) new interpretive rule implementing the orphan drug provision for new 340B covered entities under the Affordable Care Act (ACA).

As part of the 340B Drug Pricing Program, the ACA designated critical access hospitals, freestanding cancer hospitals, rural referral centers, and sole community hospitals eligible to purchase drugs at discounted rates, but excluded orphan drugs, which treat rare diseases or conditions. OPA’s rule allows these hospitals to purchase orphan drugs at discounted rates if these drugs are used for purposes other than the designated orphan drug purpose.

PhRMA successfully challenged OPA’s first attempt to issue regulations implementing the orphan drug provision, with the court deciding that OPA lacked statutory authority to issue a so-called legislative rule. OPA did not appeal that decision. However, the agency did issue a new interpretive rule to enforce effectively the same substantive interpretation. PhRMA asked the court to invalidate this new rule as part of the same lawsuit, but the court concluded the new rule is outside the scope of the initial challenge.