Eisai Files a Writ of Mandamus as a Last Resort to Get DEA to Schedule FYCOMPAAugust 23, 2013
By John A. Gilbert –
Earlier this week, Eisai, Inc. (“Eisai”) filed a Petition for A Writ of Mandamus in the U.S. Court of Appeals for the District of Columbia Circuit to force the Drug Enforcement Administration (“DEA”) to issue a Notice of Proposed Rulemaking (“NPRM”) to schedule FYCOMPA (perampanel) under the Controlled Substances Act (“CSA”). FDA approved FYCOMPA for marketing on October 22, 2012. However, as is usually the case when FDA approves a New Chemical Entity (“NCE”) that has an abuse potential, the Company “agreed” not to market the drug until DEA completes the drug scheduling process. As we previously reported, the delay will potentially adversely affect Eisai’s five-year exclusivity period if FDA maintains that the clock began ticking at the time the drug was approved. Already, almost a year has passed, yet Eisai cannot market its approved drug product because DEA has not completed the scheduling process. And, more importantly, patients are denied access to FYCOMPA unless they are participating in a clinical trial.
Unfortunately, as noted in Eisai’s court filing, such delays in scheduling are not unprecedented and, more recently, appear to be increasing. One cause is the statutory requirement for drug approval versus drug scheduling. In the latter case, while Congress in enacting the Controlled Substances Act (“CSA”) intended for both the Department of Health and Human Services (“HHS”) and FDA to have a say in how drugs are scheduled, they determined that DEA should be the final authority on scheduling drugs with an abuse potential. So, while the CSA provides that HHS must provide a scientific and medical analysis (the so-called “eight-factor” analysis) to DEA in regard to abuse potential of an NCE, HHS’s recommendation on scheduling is just that: a recommendation. DEA must still conduct its own analysis, determine in what schedule the drug should be classified and conduct the required notice and comment rulemaking to schedule the drug.
In this case it appears that HHS transmitted its findings and recommendations to DEA on January 28, 2013. Thus, even acknowledging that DEA must conduct its own review, a seven month delay without even publication of the proposed rule seems extraordinary and puzzling. This is especially true given that HHS’s medical and scientific findings on the drug are binding on DEA, by law, so DEA’s review is generally related only to data on actual or potential abuse. In addition, there is no information in the documents filed in the D.C. Circuit that there exists any significant controversy in regard to FYCOMPA (e.g., whether it has any abuse potential or some unique concern about widespread abuse, that would delay publication of the proposed rule).
To the extent that DEA’s current delay – as well as the prior examples of other drug scheduling delays cited in Eisai’s Petition – are a function in the inherent slowness of the administrative process, there are steps that federal agencies should take to ensure that the scheduling process does not delay the marketing of important medicines. First, FDA and DEA should communicate about the potential for approval, and timeline for approval, of an NCE that will likely be scheduled as a controlled substance. In the past, FDA, DEA and other concerned federal agencies routinely conducted interagency meetings related to issues affecting each agency, including drug scheduling and pending approvals. This may still be the case, but it seems more should be done to expedite the scheduling process especially given an imminent drug approval. Second, where appropriate, DEA should publish the NPRM immediately upon receipt of the eight factor analysis from HHS. This appears to have been the practice in the past. DEA would still need to finalize its review and consider any comments received before issuing a final scheduling action, but early publication of the proposed rule would potentially shorten the review time. For its part, HHS should consider submission of the eight-factor analysis to DEA as soon as practicable and before issuing the final approval of the drug. Again, this may have been done at times in the past. The one concern with DEA publishing the NPRM before approval would be the potential that the drug ultimately would not get approved and, by law, drugs must have a “currently accepted medical use” to be placed in any schedule other than schedule I. The issue of what constitutes a “currently accepted medical use” is the topic for another day. However, DEA could make the appropriate adjustments in the Final Rule should this occur.
In conclusion, HHS and DEA need to ensure a timelier drug scheduling process that does not unnecessarily hinder the marketing of important new medicines. Otherwise, given DEA’s apparent failure to act on a timely basis , Congress should consider whether HHS should be given scheduling authority in the limited cases involving the initial scheduling of approved NCEs. The Controlled Substance Staff within FDA have sufficient expertise to make such decisions. In this way the approval of the drug could be completed simultaneous to its scheduling. DEA would still retain the authority to reschedule the drug if necessary based on post-marketing abuse trends. This process would ensure that drug scheduling of NCEs does not adversely affect exclusivity, or more importantly, delay patient care.