Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Ferring Pharmaceuticals, Inc. v. Azar

United States District Court, District of Columbia

February 13, 2018

FERRING PHARMACEUTICALS, INC., Plaintiff,
v.
ALEX AZAR, [1] in his official capacity as SECRETARY, UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, and SCOTT GOTTLIEB, in his official capacity as COMMISSIONER OF THE FOOD AND DRUG ADMINISTRATION, Defendants.

          MEMORANDUM OPINION DENYING PLAINTIFF'S MOTION TO ENFORCE JUDGMENT

          RUDOLPH CONTRERAS UNITED STATES DISTRICT JUDGE.

         I. INTRODUCTION

         This case returns to this Court one year after the grant of summary judgment to Plaintiff Ferring Pharmaceuticals, Inc. (“Ferring”) due to Defendant U.S. Food and Drug Administration's (“the FDA”) surprise change of position regarding the chemical classification of a molecule within Plaintiff's colon cleansing drug, Prepopik. For years, Ferring and the FDA have agreed that picosulfate is the active moiety[2] within the molecule sodium picosulfate, one of the three active ingredients in Prepopik, and that this active moiety does not exist in any drugs previously approved by the FDA. Based on this understanding, Ferring challenged the FDA's interpretation of a rule that it believed was the only obstacle to obtaining five years of exclusivity for the drug. After the grant of summary judgment to Ferring removing this obstacle, and remand to the FDA for a determination of whether Ferring was entitled to five years of exclusivity for Prepopik, the FDA returned to Ferring with a new conclusion: that the active moiety in sodium picosulfate is actually bis-(p-hydroxyphenyl)-pyridyl-2-methane (“BPHM”), an active moiety found in several drugs that have already been approved. As such, the FDA concluded that Ferring was not entitled to five-year exclusivity for Prepopik.

         Ferring now challenges this determination as a violation of the Court's grant of summary judgment and remand to the agency, and requests that this Court order the “FDA to recognize NCE exclusivity of Prepopik, in keeping with the positions the agency has taken repeatedly throughout the regulatory process and ensuing litigation.” Mem. P. & A. Supp. Pl.'s Mot. Enforce J. (“Pl.'s Mem.”) at 17, ECF No. 64-1. For the reasons set forth below, the Court denies Ferring's motion to enforce the judgment.

         II. FACTUAL AND PROCEDURAL BACKGROUND

         Prepopik, a fixed-combination drug product used to cleanse the colon prior to colonoscopies, contains three active ingredients: sodium picosulfate, magnesium oxide, and anhydrous citric acid. A.R. 4, ECF No. 20-3. “Fixed-combinations are drug products that generally include two or more drug substances (active ingredients) in a fixed ratio, synthetically combined into a single dosage form.” A.R. 200, ECF No. 20-4. While magnesium oxide and anhydrous citric acid had already been approved in previous New Drug Applications (“NDA”) when Ferring submitted its NDA for Prepopik, sodium picosulfate had not been. Therefore, when it submitted its NDA for Prepopik, Ferring also sought five years of exclusivity for the drug as a New Chemical Entity[3] (“NCE”), which if approved would have prevented other drug manufacturers from submitting Abbreviated New Drug Applications (“ANDA”) and § 505(b)(2) NDAs[4] of generic versions for Prepopik for five years after the approval of Prepopik's NDA. 21 U.S.C. § 355(j)(5)(F)(ii).

         The FDA approved Ferring's NDA for Prepopik in 2012. A.R. 201. However, the agency refused to grant Ferring five years of exclusivity for Prepopik because two of the active ingredients in the drug (magnesium oxide and anhydrous citric acid) existed in drugs previously approved by the FDA. Id. Instead, it granted Ferring three years of exclusivity on the ground that its application “contain[ed] reports of new clinical investigations (other than bioavailability studies) essential to the approval of the application and conducted or sponsored by the applicant.” 21 U.S.C. § 355(j)(5)(F)(iii); see Ex. D, Pl.'s Mot. Enforce J. (“Pl.'s Mot.”) at 2, ECF No. 64-5; A.R. 201. The regulation governing the Food, Drug, and Cosmetic Act's five-year exclusivity provision instructs that

[i]f a drug product that contains a new chemical entity was approved after September 24, 1984, in an NDA submitted under section 505(b) of the [A]ct, no person may submit a 505(b)(2) application or ANDA under section 505(j) of the [A]ct for a drug product that contains the same active moiety as in the new chemical entity for a period of 5 years from the date of approval of the first approved NDA . . . .

21 C.F.R. § 314.108(b)(2). In contrast, the three-year exclusivity provision only precludes the FDA from approving new ANDAs and § 505(b)(2) applications before the end of the three-year period, rather than altogether prohibiting the submission of those applications. Compare 21 U.S.C. § 355(j)(5)(F)(ii), with Id. § 355(j)(5)(F)(iii).

         Ferring submitted a Citizen Petition requesting that the FDA change its exclusivity determination for Prepopik. A.R. 64. A year later, the FDA issued a response to this Citizen Petition and Citizen Petitions filed by two other pharmaceutical companies whose respective fixed-combination drug products had also been denied five-year exclusivity. A.R. 199. The FDA's response stated that it believed that its then-current interpretation of the relevant statute and regulations-that fixed-combination drugs that contain at least one previously approved active moiety cannot be granted exclusivity, even if the drug also contains at least one new active moiety-was “permissible.” A.R. 212. However, it acknowledged that its existing interpretation “may result in drug development strategies that are suboptimal from a public health perspective” because, when sponsors submit two NDAs-one for a drug with a single active-ingredient containing the new active moiety and another for a fixed-combination product-“undue importance” may be placed on “the order in which these two NDAs are approved.” A.R. 213-14. Therefore, the FDA agreed to consider altering its interpretation of the law, issuing a draft guidance and seeking public comment on a new interpretation of existing law and regulation that would “recognize 5-year NCE exclusivity for a drug substance that does not contain a previously approved active moiety, even where such a drug substance is approved in a fixed-combination with another drug substance that contains at least one previously approved active moiety.” A.R. 214.

         Despite the fact that Prepopik met this new standard, the FDA refused to grant it five years of exclusivity because “[e]xclusivity runs from the date of approval of the product” and the agency's old interpretation had been in effect on the date Prepopik's NDA had been approved. A.R. 215. After filing a Petition for Reconsideration and Petition for Stay, which the FDA denied, Ferring filed this action in federal court, alleging that the FDA's denial of its application was contrary to the Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301-399b, and the agency's own regulations, and that its refusal to apply the new interpretation was arbitrary and capricious in violation of the Administrative Procedure Act, 5 U.S.C. § 706(2)(A). See Compl. ¶¶ 58-71, ECF No. 2. As a remedy, Ferring sought “a declaratory judgment declaring that the FDA's determination of the exclusivity period for Prepopik violates the [APA]” and “injunctive relief ordering the FDA to grant the full five years of exclusivity for Prepopik.” Compl. ¶ 9.

         On first review, the Court denied Ferring all of the relief it requested. See generally Ferring Pharm. Inc. v. Burwell (“Ferring I”), 169 F.Supp.3d 199 (D.D.C. 2016). Performing a Chevron analysis, at Step One the Court found that it was ambiguous whether the term “drug” in the relevant sentence of the statute referred to drug substances or drug products. Ferring I, 169 F.Supp.3d at 211-12 (citing Chevron, U.S.A., Inc. v. Nat. Res. Def. Council, Inc., 467 U.S. 837 (1984)). At Chevron Step Two, it found that the agency's original construction of the statute was reasonable, even though that construction assigned different meanings to the term “drug” within the same sentence of statutory text. Id. at 212-17. It similarly found that the original interpretation was not arbitrary and capricious. Id. at 217-19. This holding was in part predicated on the fact that Ferring had not produced any examples of the original interpretation creating circumstances in which a drug substance's eligibility for five-year exclusivity turned on the order in which NDAs were approved. Id. at 218 (“If there were, in fact, situations in which a drug was eligible for five-year exclusivity under FDA's prevailing interpretation but failed to receive it because of the order in which it was approved, those circumstances might render FDA's policy arbitrary and capricious.”).

         Following the Court's grant of summary judgment to the FDA, Ferring moved for reconsideration on the grounds that it could identify several examples of a single-entity drug substance being denied five-year exclusivity due to the order in which the NDAs for drugs that include that substance were approved. See Mem. P. & A. Supp. Pl.'s Mot. Recons. (“Pl.'s Mot. Recons. Mem.”) at 1-3, ECF No. 39-1. The Court granted the motion for reconsideration, entered summary judgment for Ferring, and “remand[ed] th[e] action to FDA for further proceedings not inconsistent with [its] opinion.” Ferring Pharm., Inc. v. Burwell (“Ferring II”), No. 15-802, 2016 WL 4734333, at *11 (D.D.C. Sept. 9, 2016).

         It is the result of this remand that Ferring now challenges. Throughout the NDA process, the NCE exclusivity Citizen Petition process, and this litigation, the FDA has consistently agreed with Ferring that the active moiety in sodium picosulfate is picosulfate. For example, when Ferring submitted its NDA for Prepopik, the FDA classified the NDA as a “Type 1 - New Molecular Entity” submission. See FDA, Drugs@FDA: FDA Approved Drug Products, Prepopik (NDA 202535), https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm. The term “new molecular entity” is not defined by statute or regulation, but the FDA defines the term as “an active ingredient that contains no active moiety that has been previously approved by [the FDA] in an [NDA] or has been previously marketed as a drug in the United States.” See FDA, Drugs@FDA Glossary, https://www.fda.gov/drugs/informationondrugs/ucm079436.htm. Implied in that classification is the determination that sodium picosulfate contains an active moiety that had not previously been approved because magnesium oxide and anhydrous citric acid contain active moieties that had already been approved. Throughout the course of this litigation, the FDA never altered its determination that sodium picosulfate contains a not previously approved active moiety-until now.

         Eight months after the Court remanded this matter back to the FDA for further proceedings consistent with its arbitrary and capriciousness finding, the FDA changed its mind regarding the identity of the active moiety in sodium picosulfate. It now believes, upon “further review, ” that the active moiety in sodium picosulfate is not picosulfate, but rather BPHM, an active moiety that is also found in other previously approved drug products. Ex. B at 2, Pl.'s Mot., ECF No. 64-3. As such, it concluded that Prepopik was not entitled to five-year NCE exclusivity. Ex. D at 8-9, Pl.'s Mot.

         The agency's change in position is based in its new chemical analysis of picosulfate. Following its review of Ferring's application for five-year NCE exclusivity, it explained that “[a]t the time the Prepopik application was submitted, the Agency determined that sodium picosulfate was [an NME]. It was believed that picosulfate was the active moiety of the drug substance sodium picosulfate, and that this active moiety had not been previously approved by FDA.” Id. at 7.

         The agency has given no indication of why this determination was made. It admits that “[i]t is not clear from the administrative record how the Agency determined that sodium picosulfate was considered to be an NME, as no documentation of a structural analysis of this active ingredient has been found.” Id.[5] The agency continues that at the time of its approval of Prepopik's NDA and its initial denial of the application of five-year NCE exclusivity, “there was no need to closely examine the structure of picosulfate to more thoroughly assess the assumption that it did not contain a previously approved active moiety, ” because, using the agency's interpretation of ...


Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.