June 19, 2014—The Health Resources and Services Administration acted “wholly at odds” with a federal district judge’s orders when it announced yesterday that it stands by its interpretation of the 340B orphan drug exclusion, brand-name drugmakers argued in papers filed with the judge late on June 18. [ms-protect-content id=”2799″]
Pharmaceutical Research and Manufacturers of America asked U.S. District Judge Raul Contreras either to order a new round of briefs on whether HRSA’s 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 posting yesterday on the Office of Pharmacy Affairs website, HRSA indicated it will hold drug manufacturers responsible for providing critical access hospitals, sole community hospitals, rural referral centers, and free-standing cancer hospitals access to 340B pricing on orphan drugs when they “are used for any indication other than treating the rare disease or condition for which the drug received an orphan designation,” as spelled out in a July 2013 final regulation.
The regulation took effect on Oct. 1. Judge Contreras invalidated the regulation on May 23, holding that HRSA 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. The judge also left open whether the rule could be upheld as an interpretative rule and invited HRSA to submit briefs on the issue. The government declined to do so in a June 12 filing, noting that it “does not interpret the court’s decision as precluding it from issuing an interpretative rule or other type of interpretative guidance, even if that rule or guidance sets forth the same interpretation previously embodied in the challenged regulation.”
“PhRMA is concerned that [the Department of Health and Human Services] is ignoring the court’s opinion,” the trade association said in its June 18 filing. “HHS’s attempt to stand behind its flawed rulemaking, now through a posting on its website, is wholly at odds with this court’s decision.” Elsewhere in its filing, PhRMA said “HHS’s actions are in direct circumvention of this court’s ruling….the agency is treating the final rule as if it were in effect.” [/ms-protect-content]