FDA Appeals PREPOPIK NCE Exclusivity Decision to the D.C. Circuit; Similarly Situated Parties Petition FDA

November 16, 2016

By Kurt R. Karst

Last week, FDA filed a Notice of Appeal with the U.S. Court of Appeals for the District of Columbia Circuit appealing a September 9, 2016 Final Judgment and Order from DC District Court Judge Rudolph Contreras concerning Ferring Pharmaceuticals Inc.’s (“Ferring’s”) eligibility for 5-year New Chemical Entity (“NCE”) exclusivity for PREPOPIK (sodium picosulfate, magnesium oxide, and citric acid) for Oral Solution, which FDA approved under NDA 202535 on July 16, 2012 (and granted a period of 3-year exclusivity that expired in July 2015).  Although Judge Contreras remanded the action to FDA for further proceedings consistent with his September 2016 Memorandum Opinion, FDA decided instead to seek review by the DC Circuit. 

By way of background (and as summarized by Judge Contreras in his March 2016 Memorandum Opinion), “prior to 2014, the FDA interpreted the five-year exclusivity provision to provide that only drug products containing no previously approved drug substances were eligible for exclusivity.  Once eligible, however, the FDA interpreted the bar clause to bar all ANDAs and 505(b)(2) applications referencing that drug product or any later-approved products containing the product’s drug substances, in order to preserve the innovator’s exclusivity to the greatest extent possible.” [(Emphasis in original)]  FDA’s new interpretation, which the Agency has applied only to Fixed-Dose Combination (“FDC”) drug products approved after October 2014, is discussed in a final guidance document issued that same month.  In short, FDA’s reinterpretation of the statutory NCE exclusivity provisions allows for an award of NCE exclusivity for a newly approved FDC drug product containing an NCE and a previously approved drug. 

As we previously reported, Judge Contreras granted Ferring’s Motion for Reconsideration of the DC District Court’s March 15, 2016 ruling that FDA’s pre-October 10, 2014 interpretation of the FDC Act’s 5-year NCE exclusivity provisions as applied to a newly approved FDC drug product containing an NCE and a previously approved drug – and specifically, to Ferring’s PREPOPIK – was not arbitrary and capricious. According to Judge Contreras:

In its motion for reconsideration . . . Ferring now provides three examples that lead the Court to doubt the factual basis for its [March 2016] conclusion. In each instance, a drug substance that had never been previously approved was included as part of a fixed-combination drug product (a fixed-combination drug product that did not receive five-year exclusivity because it contained other, previously approved drug substances).  And, in each case, a single-entity version of the drug substance was later approved, but did not receive the benefit of a five-year exclusivity period, because the drug substance had been previously approved as part of the fixed-combination product. . . .

These newly highlighted examples now show that, even if the FDA’s prior interpretation is reasonable under Chevron Step Two from a conceptual standpoint, that interpretation produces circumstances that fail to treat “similar cases in a similar manner.” [(Internal citations omitted)]

Briefing in the appeal gets underway in December with procedural and dispositive motions due on December 9 and December 27, 2016, respectively (from both FDA and Ferring).

Meanwhile, the sponsor of one NDA cited by Judge Contreras as one of the “newly highlighted examples” has petitioned FDA in light of the DC District Court’s September 2016 decision. Specifically, Gilead Sciences, Inc. (“Gilead”), the sponsor of NDA 203100 for STRIBILD (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) Tablets (approved on August 27, 2012), submitted a Citizen Petition (Docket No. FDA-2016-P-3312) to FDA in October 2016 requesting that:

In light of the recent district court’s decision in Ferring v. Burwell, . . . FDA promptly award five-year NCE exclusivity to Stribild, . . . and extend such exclusivity under FDA’s “umbrella policy” to later-approved Gilead products containing the new active moieties, specifically Tybost® and Vitekta®.  Additionally, because all of these drug products should have been protected against the receipt of an [ANDA] before August 27, 2016, Gilead requests that FDA withdraw its January 2016 receipt of the Mylan ANDA 208982 referencing Tybost, as well as any other ANDA filed before August 27, 2016 that references a drug containing elvitegravir or cobicistat.

Of course, Gilead is the company primarily responsible for FDA issuing guidance in October 2014 reinterpreting the FDC Act’s NCE exclusivity provisions with respect to FDC drug products. In January 2013, Gilead petitioned FDA (Docket No. FDA-2013-P-0058) to change the Agency’s interpretation.  As noted above, and as discussed in FDA's petition response to Gilead (see here), FDA did change the Agency's interpretation, but only prospectively.

After Gilead submitted its Citizen Petition to FDA, several other interested parties submitted petitions to the Agency (see our previous posts here and here), including a Citizen Petition (Docket No. FDA-2014-P-0737) from Pfizer Inc. (“Pfizer”) with respect to DUAVEE (conjugated estrogens/bazedoxifene) Tablets (NDA 022247; approved on October 3, 2013).  

In another new Citizen Petition (Docket No. FDA-2016-P-3082) submitted to FDA in early October 2016, Pfizer, like Gilead after it, requests that FDA recognize 5-year NCE exclusivity for bazedoxifene, the new active moiety in DUAVEE, as a result of the DC District Court’s decision in Ferring v. Burwell. “DUAVEE is similarly situated to Ferring’s drug PREPOPIK, as an FDC drug product containing both an NCE and previously-approved drug substance to which FDA applied its historical interpretation of the FDCA to grant 3-year exclusivity,” says Pfizer.  “Pfizer therefore seeks FDA’s reconsideration of its decision not to grant 5-year exclusivity to bazedoxifene, in light of the September 9, 2016 decision in Ferring v. Burwell, holding FDA’s prior interpretation of the FDCA’s exclusivity provisions arbitrary and capricious.”  Unlike PREPOPIK and STRIBILD (including elvitegravir or cobicistat), FDA has not yet received (i.e., filed) any ANDAs for generic versions of DUAVEE.