DEA didn’t waste time during its Thanksgiving break. Monday, in just shy of three weeks of the close of its comment period on its proposed rule, DEA issued a final rule placing perampanel in Schedule III. We previously reported on DEA’s delay in issuing a Notice of Proposed Rulemaking (“NPRM”) to schedule the drug and the impact on drug manufacturer, EISAI, here, here, and here.
DEA’s quick turnaround is not surprising in light of EISAI’s recent suit where it requested that the Court of Appeals for the D.C. Circuit issue a writ of mandamus ordering DEA promptly to schedule perampanel. Perampanel is the active pharmaceutical ingredient (“API”) in EISAI’s drug, FYCOMPA, that FDA approved last year. FDA has taken the position that the exclusivity clock began to run upon the drug's approval, although EISAI cannot market the drug until it is scheduled by DEA (see our prior post here). FDA sent its scientific and medical evaluation to DEA in January of 2013, but as of October, the agency had yet to take any discernable action on it. While the Court declined to grant the writ, shortly after DEA promised to issue a NPRM by the end of the month, the Court warned that “petitioner may once again seek relief in this court should the Drug Enforcement Administration fail to adhere to its envisioned schedule.” Fear of once again being dragged into federal court may have prompted the agency to move quickly.
The final order scheduling FYCOMPA will not be effective until January 2, 2014. DEA declined to follow a commenter’s request that DEA make the regulation effective - and thus the drug available - immediately. DEA reasoned that final orders are required by regulation to become final no less than 30 days after publication and “that the conditions of public health or safety do not necessitate . . . an earlier effective date.” Id. at 72,014 (citing 21 C.F.R. § 1308.45). It explained that there are medications currently available with the same indications as perampanel, yet different mechanisms of action, and that delaying effectiveness of the final rule by 30 days will “allow handlers to obtain the appropriate registration with the DEA and to comply with regulatory requirements for handling schedule III controlled substances.” Id. For manufacturer EISAI, who has already lost 13 months of exclusivity during DEA’s delay, January 2nd likely can’t come soon enough.