On August 19, Eisai Incorporated (“Eisai”) filed a Writ of Mandamus to Redress Unreasonable Delay by the Drug Enforcement Administration (“Writ”) to compel the Drug Enforcement Agency (“DEA”) to issue a Notice of Proposed Rulemaking (“NPRM”) within ten days of the Writ and otherwise expedite its drug scheduling for Fycompa® (perampanel). According to Eisai, DEA’s failure to initiate the scheduling of Fycompa® almost seven months after receiving a scheduling recommendation from the Assistant Secretary for Health (“ASH”) “constitutes unreasonable and egregious delay warranting mandamus.” In Eisai’s opinion, mandamus is warranted because: “(i) many thousands of patients who may benefit from the drug cannot obtain it, (ii) the drug’s sponsor is unable to benefit from FDA’s approval [of Fycompa®, and (iii) the burden on DEA of scheduling this drug is very small.”
Eisai’s Writ explained the process where FDA sends its drug scheduling recommendation through the ASH to DEA to initiate a scheduling proceeding “within a reasonable time” to permit the drug to be marketed with the appropriate scheduling safeguards. Under the Controlled Substances Act (“CSA”), if a drug has the potential for abuse, it must be subject to DEA scheduling, which considers “the eight-factor analysis” indicative of abuse potential and places the drug in one of five drug schedules. Schedule II is the most restrictive category where the drug is still accepted to have an accepted medical use, and Schedule V is the least restrictive schedule with an accepted medical use yet a low potential for abuse, physical dependence, or psychological dependence relative to other drugs or substances in Schedule IV.
The CSA permits DEA to add, change, or delete a substance’s schedule at any time by FDA/Health and Human Services or by petition from ay interested person or entity. The process that Eisai referred to, however, is the initial approval of a new chemical entity (“NCE”), where there was previously no schedule for the drug substance, and FDA recommends that a drug be scheduled prior to marketing. Although FDA lacks the direct authority to restrict marketing of products with pending DEA scheduling orders, FDA includes FDA Form 356h as a cover sheet for all new drug applications (“NDAs”) with a statement that the sponsor will not market until DEA makes a final scheduling decision. In the past, sponsors have honored these commitments to wait for a final scheduling decision before marketing their FDA-approved NDAs. Sponsors have waited despite FDA starting the clock for the five-year NCE exclusivity from the date of FDA’s approval letter rather than the final DEA scheduling, i.e., losing exclusive marketing time.