Perrigo Sues FDA Over Failure to Grant Therapeutic Equivalence Rating for Testosterone Gel 505(b)(2) NDA

By Kurt R. Karst –       

In a Complaint filed last Friday in the U.S. District Court for the District of Columbia, Perrigo Israel Pharmaceuticals Ltd. and Perrigo Company (collectively “Perrigo”) (represented by Hyman, Phelps & McNamara, P.C.) allege that FDA has shirked a duty under the Federal Food, Drug, and Cosmetic Act (“FDC Act”) by failing to timely act to update the Orange Book to add a Therapeutic Equivalence (“TE”) rating for Perrigo’s Testosterone Gel, 1%, drug product approved under NDA No. 203098.  FDA approved NDA No. 203098, submitted pursuant to FDC Act § 505(b)(2), well over a year ago on January 31, 2013.  According to Perrigo, FDA “had an obligation at that time to update the Orange Book with a TE rating for Perrigo’s Product,” but “despite repeated requests by Perrigo to FDA asking the Agency to publish a TE rating for Perrigo’s Product, and despite publishing TE ratings for numerous other drugs approved after Perrigo’s Product, FDA has not fulfilled its statutory obligation.”  FDA determined Perrigo’s drug product to be bioequivalent to the listed drug relied on for approval, namely ANDROGEL (testosterone gel) 1%, based on data and information contained in Perrigo’s NDA.  Perrigo’s drug product is also pharmaceutically equivalent to ANDROGEL.

Under FDC Act § 505(j)(7)(A)(i), FDA is required to publish in the Orange Book three distinct pieces of information:

(I) a list in alphabetical order of the official and proprietary name of each drug which has been approved for safety and effectiveness under subsection (c) of this section before September 24, 1984;

(II) the date of approval if the drug is approved after 1981 and the number of the application which was approved; and

(III) whether in vitro or in vivo bioequivalence studies, or both such studies, are required for applications filed under this subsection which will refer to the drug published.

While each subsection of FDC Act § 505(j)(7)(A)(i) imposes a discrete nondiscretionary statutory duty on FDA, only the latter two subsections – and specifically the third subsection – are at issue in Perrigo’s Complaint.

FDA has stated on several occasions that the Agency fulfills the statutory duty at FDC Act § 505(j)(7)(A)(i)(III) through the use of TE codes in the Orange Book.  See, e.g., 54 Fed. Reg. 28,872, 28,911 (July 10, 1989); 21 C.F.R. § 320.24(a); FDA Petition Response, Docket No. FDA-2012-P-0499, at 7-10 (Nov. 13, 2012); FDA Petition Response, Docket No. FDA-2006-P-0346, at 36-40 (Aug. 22, 2012).   Under FDC Act § 505(j)(7)(A)(ii), “[e]very thirty days after the publication of the first list under clause (i),” FDA is required to “revise the list to include each drug which has been approved.”  The obligation to revise the Orange Book “under clause (i)” (i.e., under FDC Act § 505(j)(7)(A)(i)) includes Subsection (i)(III), which FDA has said it meets through the publication of TE codes in the Orange Book. 

As an aside, two Citizen Petitions (Docket Nos. FDA-2011-P-0610 and FDA-2013-P-0371) challenge FDA’s authority to assign TE ratings to 505(b)(2)-approved drug products, and, in particular, 505(b)(2) applications approved for testosterone gel, absent rulemaking under the Administrative Procedure Act (“APA”) (see our previous post here).  Nevertheless, as Upsher-Smith Laboratories recently noted in comments to FDA, the Agency has continued to assign TE ratings to 505(b)(2)-approved drug products despite the petitions.

Perrigo alleges that FDA has violated the FDC Act and the APA by failing to publish a TE rating with respect to Perrigo’s NDA No. 203098.  The company asks the court for both injunctive and declaratory relief.  Specifically, Perrigo asks the court to enter a mandatory preliminary injunction compelling FDA to publish a TE rating for Perrigo’s NDA No. 203098 as soon as possible (and in any event no later than 14 days from the date a preliminary injunction is entered and throughout the pendency of the case), and a declaratory judgment that FDA’s failure to provide the non-discretionary statutorily-required published TE rating constitutes agency action unlawfully withheld and unreasonably delayed.  In addition, Perrigo asks for a permanent injunction upon the completion of a trial on the merits.