By Delia A. Stubbs & John A. Gilbert –
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 exclusivity clock began to run upon its 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 and get out of dodge.
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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 exclusivity clock began to run upon its 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 and get out of dodge.
continue to read here
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