Drugs with abuse potential fall under the Controlled Substances Act (CSA) and may not be marketed until they have been assessed by the DEA (US Drug Enforcement Agency).
The US Food and Drug Administration (FDA) approved Eisai’s weight loss drug Belviq (lorcaserin) in June 2012 but it was not scheduled by the DEA until June 2013. Fycompa (perampanel, an antiepileptic) was authorised in October 2012 but listed in January 2014. The result, said Eisai, is “Belviq will lose almost one year and Fycompa will lose more than one year of their respective five-year market exclusivity periods.”
The suit brought by the Japanese company argues against the current practice of counting the five-year exclusion period from the date of the FDA’s approval letter:
“FDA’s letters make clear that the products’ labelling would need further revisions once CSA scheduling was complete. […] After CSA scheduling, a revision to the labelling was expressly required before the product could be legally marketed. Therefore, the date of the approval letters cannot be considered the triggering date for market exclusivity purposes.”
Suzanne Grogan, Eisai spokeswoman, told in-PharmaTechnologist.com, “We believe the five-year market exclusivity period should only be triggered when products are able to be legally marketed, which is when scheduling is finalized and labelling incorporates the scheduling information.
“This would ensure that all sponsors of drugs that require scheduling are awarded the full five years of market exclusivity that sponsors of drugs that do not require DEA scheduling receive.”
Eisai’s suit comes one year after it filed a Citizen Petition to the FDA asking for changes to exclusivity start date rules. The FDA denied that request as well as a similar Citizen Position submitted by UCB, which was concerned with losing marketing time for its Vimpat (lacosamide).
The Japanese company also tried last year to legally order the DEA to speed up its scheduling process, but the petition was denied by the US Court of Appeals.
Kurt Karst, a director at pharmaceutical law firm Hyman, Phelps & McNamara, told in-PharmaTechnologist.com the roadblock has more to do with the DEA than the FDA. “A lot of the delays are on the DEA’s side of the fence. It’s primarily a DEA problem but the effects are being felt on the FDA side.”
He suggested earlier communication and more prompt starts to scheduling could speed up the process. “I think the majority of the delay is the DEA isn’t scheduling in a prompt manner and the bureaucratic process is getting in the way.”
As to whether the suit is likely to succeed, Karst told us that while suing the FDA is “an uphill battle”, “they have some nice arguments and they’ve got one precedent where FDA apparently changed the exclusivity period consistent with what they want. So they do have one outlier case on their side.”