By Delia A. Stubbs –
Earlier this week, the U.S. Court of Appeals for the D.C. Circuit denied Eisai, Inc.’s (“Eisai’s”) petition to order DEA – in essence – to get moving on the scheduling of its drug, FYCOMPA (perampanel), which FDA approved in October 2012 under NDA No. 202834. As previously reported here, Eisai argued that DEA’s failure to initiate a rulemaking proceeding nearly one year after FDA approved the drug (and granted Eisai five years of new chemical entity exclusivity, though the start of that exclusivity is being contested – see here) was unreasonable and asked the court to order DEA to act promptly. In response, DEA promised in its opposition to issue a Notice of Proposed Rulemaking (“NPRM”) by the end of October. DEA delivered on that promise by proposing to place FYCOMPA in Schedule III. Interestingly, despite this action, the three-judge panel comprised of Judges Henderson, Griffith, and Kavanaugh still reached the merits of Eisai’s petition, and found that Eisai had not shown that the agency’s delay warranted the extraordinary remedy of mandamus. This departs somewhat from recent rulings by the District Court in similar challenges. See Order at 2, Prevor v. FDA, No. 11-1187 (D.D.C. May 8, 2013) (holding plaintiff’s motion to compel FDA to act timely in abeyance in light of FDA’s promise to act by a date certain).
More importantly, even in the absence of a writ, the question remains whether a better process could be crafted to more efficiently schedule NCEs. See our prior post, here. In its opposition, DEA explained its delay was based in part on its need to conduct an independent evaluation of FDA’s scientific and medical fact findings, despite their ultimate binding nature on the agency. Response in Opposition to Petition for Writ of Mandamus at 1, 6, In Re EISAI, Inc., USCA Case # 13-1243, (D.C. Cir. Sept. 4, 2013) (“Opposition”); See also Schedules of Controlled Substances: Placement of Carisoprodol Into Schedule IV, 76 Fed. Reg. 77,330 (Dec. 12, 2011). (A copy of Eisai’s Reply Brief is available here.) DEA reasoned that its re-evaluation ensures its conclusions are adequately founded, in case they are later challenged in court. Opposition at 6-7. However, this response is still inadequate if the result will continue to be that companies like Eisai lose exclusivity rights in cases where there is a significant delay between FDA transmitting its recommendations to DEA and DEA issuing the scheduling decision.
Comments and request for hearing by interested parties on the NPRM must be filed by November 21, 2013.