July 3, 2014—Federal government and drug industry lawyers have discussed but been unable to agree on the terms of a cooperative resolution to the drugmakers’ latest motion in their suit over the 340B orphan drug exclusion regulation, the government said in a July 2 filing in the case.[ms-protect-content id=”2799″]
The government currently has a July 7 deadline to respond to Pharmaceutical Research and Manufacturers of America’s June 18 motion asking U.S. District Judge Raul Contreras either to order a new round of briefs on whether the 340B orphan drug exclusion regulation can survive as an “interpretative” rather than “legislative” rule or to enter a judgment declaring that it cannot. In its July 2 filing, the government cited its recent discussions with PhRMA plus the upcoming Independence Day holiday in asking for a seven-day extension, until July 14, to file its response to PhRMA’s motion. The drug industry does not oppose the government request.
The disputed July 2013 regulation requires drug manufacturers to provide critical access hospitals, sole community hospitals, rural referral centers, and free-standing cancer hospitals access to 340B pricing on orphan drugs when such drugs “are used for any indication other than treating the rare disease or condition for which the drug received an orphan designation.” Judge Contreras invalidated the regulation on May 23, holding that the Health Resources and Services Administration lacked authority to issue a legislative regulation to implement the orphan drug exclusion.
While the judge ruled that HRSA lacked legislative rulemaking power with respect to the orphan drug exclusion, he made no decision about whether the policy advanced in the regulation was valid and could be implemented by HRSA as an “interpretative policy” rather than as a “legislative rule.” Early in the day on June 18, HRSA announced that it continues to stand by its interpretation of the 340B orphan drug exclusion. It said that although the court vacated the regulation, the court “did not invalidate HRSA’s interpretation of the statute.” In its July 18, PhRMA said HRSA’s position was “wholly at odds” with the judge’s ruling.[/ms-protect-content]