November 20, 2014—Final briefs in the drug industry’s second lawsuit over the 340B orphan drug exclusion will be due in late March 2015, under a federal district court scheduling order filed this week. [ms-protect-content id=”2799″]
Judge Rudolph Contreras, who presided over Pharmaceutical Research and Manufacturers of America’s first suit against the Department of Health and Human Services, has been assigned to hear PhRMA’s follow-up suit, which the trade group filed on Oct. 9. PhRMA argues that the Health Resources and Service Administration’s July 2014 orphan drug exclusion interpretative rule “contains the same substance” as its July 2013 final rule, which Judge Contreras invalidated this past May, “and should similarly be invalidated as inconsistent with the statute.”
On the Office of Pharmacy Affairs website, HRSA says that while Judge Contreras vacated the final rule on the ground that HRSA lacked statutory authority to engage in such rulemaking, he “did not invalidate HRSA’s interpretation of the statute.”
HRSA says it “continues to stand by the interpretation described in its published final rule, which allows the 340B covered entities affected by the orphan drug exclusion to purchase orphan drugs at 340B prices when orphan drugs are used for any indication other than treating the rare disease or condition for which the drug received an orphan designation.”
Judge’s Contreras’s Nov. 18 scheduling order sets deadlines from early December through late March for various filings by both sides in the dispute. For example, the government’s motion for summary judgment is due by Jan. 16, and PhRMA’s opposition brief and cross-motion for summary judgment is due by Feb. 13. [/ms-protect-content]