By Kurt R. Karst –
We thought Eisai Inc.’s (“Eisai”) beef with FDA over New Chemical Entity (“NCE”) exclusivity might resurface at some point . . . and now it has. Last Friday, Eisai filed a Complaint in the U.S. District Court for the District of Columbia alleging that FDA erroneously triggered periods of 5-year NCE exclusivity for two drug products – BELVIQ (lorcaserin HCl) Tablets (NDA No. 022529; approved on June 27, 2012) and FYCOMPA (perampanel) Tablets (NDA No. 202834; approved on October 22, 2012) – by using the NDA approval dates instead of the dates the products could be legally marketed to calculate the five-year exclusivity terms.
BELVIQ and FYCOMPA contain controlled substances that required scheduling decisions by the DEA under the Controlled Substances Act (“CSA”) before the drug products could be marketed. Those decisions did not become effective until June 7, 2013 for BELVIQ and until January 2, 2014 for FYCOMPA. Eisai unsuccessfully challenged the DEA in Court over the glacial pace of the scheduling decision for FYCOMPA (see our previous post here). Congress is currently considering legislation to speed up DEA scheduling decisions (see our previous post here).
As we previously reported (here and here), Eisai submitted a Citizen Petition (Docket No. FDA-2013-P-0884) to FDA in 2013 requesting that the Agency conclude that the NCE exclusivity start dates for BELVIQ and FYCOMPA are triggered only when FDA-approved labeling incorporating the final DEA CSA scheduling permits commercial marketing of the drug products, and not on the date of NDA approval. FDA denied Eisai’s petition requests (as well as those of another petitioner for a different drug) in April 2014. According to FDA, “[t]he legal and regulatory framework on exclusivity and drug approvals contemplate only a single date of approval for determining when exclusivity begins for an NDA. For each NDA at issue, that date is the date that FDA completes its review and issues an approval letter.”
Eisai alleges in its August 8, 2014 Complaint that FDA violated the FDC Act and the Administrative Procedure Act (“APA”) by using the NDA approval dates as the triggering events to start the NCE exclusivity periods, thereby possibly accelerating by a year or more the timing of future generic competition for BELVIQ and FYCOMPA. According to Eisai:
[C]onsistent with FDA’s regulation—21 C.F.R. §314.108(a)—the governing statute, and clear congressional intent, market exclusivity for BELVIQ® and FYCOMPA® should have been triggered when labeling incorporating the final CSA schedule permitted legal marketing of the products. FDA’s letters approving the products as safe and effective reinforce this requirement. FDA’s letters make clear that the products’ labeling would need further revisions once CSA scheduling was complete. . . . Thus, after CSA scheduling, a revision to the labeling 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.
Eisai also takes issue with FDA’s alleged different treatment of BELVIQ and FYCOMPA compared to other NCEs and similarly situated products. “FDA is unfairly penalizing Eisai for developing and seeking to commercialize NCEs recommended for CSA scheduling,” says Eisai. “While BELVIQ® and FYCOMPA® will be deprived of their full five-year market exclusivity periods, sponsors of NCEs that do not require CSA scheduling enjoy full five-year exclusivity periods.” Moreover, argues Eisai,
FDA’s actions have also resulted in disparate treatment among sponsors of CSA scheduled products themselves. For example, an examination of NCEs that FDA recommended for scheduling demonstrates that FDA submitted its recommendation to DEA anywhere from 367 days before issuing an approval letter (PROVIGIL®) to as many as 94 days after issuing an approval letter (LYRICA®). FDA has offered no explanation and no sound policy rationale for this disparate treatment, even though FDA’s wildly varying timeframe for providing DEA with scheduling recommendations can substantially diminish an NCE’s five-year market exclusivity period.
Eisai also says that FDA’s refusal to recognize the dates BELVIQ and FYCOMPA could be legally marketed as the start dates for NCE exclusivity is inconsistent with at least one previous FDA decision concerning RAZADYNE ER (galantamine hydrobromide) Extended-release Capsules, which FDA approved on December 22, 2004 under NDA No. 021615. According to Eisai:
On June 13, 2006, long after RAZADYNE® ER was commercially launched, FDA decided to reach back and move the date triggering the drug’s exclusivity period to April 1, 2005, because the agency concluded that was the earliest date that RAZADYNE® ER could have been marketed. FDA then officially changed the trigger date for RAZADYNE® ER’s market exclusivity period from December 22, 2004 to April 1, 2005 in the Orange Book. . . . Despite this clear agency precedent, FDA has refused to take such appropriate actions with regards to BELVIQ® and FYCOMPA®. And, in doing so, FDA has also failed to provide a reasonable basis for treating BELVIQ® and FYCOMPA® differently.
Finally, Eisai argues that FDA’s denial of the company’s Citizen Petition was arbitrary, capricious, and short of statutory right. “In denying the Petition, FDA ignored its clear statutory mandate from Congress to ensure that products such as BELVIQ® and FYCOMPA® receive full five-year market exclusivity periods,” writes Eisai, which also lays out in the Complaint several reasons as to how FDA’s decision is improper.
Eisai requests that the court declare FDA’s decision as to BELVIQ’s and FYCOMPA’s NCE exclusivity periods to be a violation of the APA. Eisai also wants the court to compel FDA to commence the 5-year exclusivity periods for both drug products on the date each drug’s CSA scheduling was complete and labeling incorporating the scheduling information allowed the products to be launched into interstate commerce (i.e., June 7, 2013 for BELVIQ, and January 2, 2014 for FYCOMPA.)