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Amgen Inc. v. Azar

United States District Court, District of Columbia

February 17, 2018

AMGEN INC., Plaintiff,
ALEX AZAR II, Secretary, U.S. Department of Health and Human Services, et al., Defendants, and AMNEAL PHARMACEUTICALS, LLC, Intervenor-Defendant.



         Amgen brought this action to challenge the decision of the Food and Drug Administration (“FDA”) denying Amgen pediatric exclusivity for its drug, Sensipar (cinacalcet hydrochloride). In an earlier opinion and order, the Court granted the FDA summary judgment on all but one of Amgen's claims: its claim that the agency's denial of pediatric exclusivity for Sensipar was inconsistent with its decision to grant pediatric exclusivity for Johnson & Johnson's drug Ortho Tri-Cyclen. Amgen Inc. v. Hargan, __ F.Supp.3d __, 2018 WL 581006 (D.D.C. Jan. 26, 2018). As to that claim, the Court concluded that the FDA had failed to offer a “reasoned explanation” for why it reached a “disparate outcome[]” with respect to Ortho Tri-Cyclen. Id. at *15-18. On remand, the FDA reaffirmed its Sensipar decision and explained why, in its view, this result was consistent with its decision on Ortho Tri-Cyclen. See AF.2d 1-5 [hereinafter Remand Decision]. After a last-minute discovery of an additional document relating to the FDA's Ortho Tri-Cyclen decision, Dkt. 78, the Court remanded the case to the FDA “to address [Amgen]'s claim of inconsistent treatment in light of [the] newly discovered information, ” Minute Order (Feb. 7, 2018). The FDA issued an addendum to its Remand Decision, again concluding that its Sensipar and Ortho Tri-Cyclen decisions were not inconsistent. See AF.3d 1-4 [hereinafter Remand Addendum]. Amgen has now renewed its motion for summary judgment on the grounds that the FDA's latest explanation is inadequate and that its denial of pediatric exclusivity for Sensipar thus remains arbitrary and capricious. Dkt. 83. The FDA, in turn, has renewed its cross-motion for summary judgment. Dkt. 84. For the reasons that follow, the Court will DENY Amgen's motion and will GRANT the FDA's cross-motion.[1]

         I. BACKGROUND

         Because the Court has already recounted the factual and legal background at length, see Amgen, 2018 WL 581006, at *1-6, only a brief summary of the background relevant to the pending motions is necessary. Subject to other requirements not relevant here, the sponsor of a new drug application will qualify for six months of pediatric exclusivity if (1) the FDA determines that “information relating to the use of [the] new drug in the pediatric population may produce health benefits in that population, ” 21 U.S.C. § 355a(b)(1); (2) it “issue[s] to the sponsor [of the drug] a written request for the conduct of pediatric studies for such drug, ” 21 U.S.C. § 355a(d)(1)(A); and (3) the sponsor's reports on its pediatric studies are “submitted [to] and accepted” by the FDA, 21 U.S.C. § 355a(b)(1). The pediatric exclusivity statute further provides, in relevant part, that the FDA's “only responsibility in accepting or rejecting the reports shall be to determine . . . whether the studies fairly respond to the written request.” 21 U.S.C. § 355a(d)(4) (emphasis added). Under the FDA's interpretation of this provision, the “fairly respond” requirement is satisfied if a sponsor “meets the terms” of the written request or if the sponsor's studies yield information that is “clinically meaningful across all age groups and uses cited” in the request, thus satisfying the objectives of the request. AR 1637.

         The FDA denied Amgen's request for pediatric exclusivity for Sensipar because Amgen's studies did not, in the agency's view, “fairly respond” to the written request, AR 1389, and it reaffirmed that decision in subsequent administrative proceedings, AR 1484; AR 1632. According to the FDA, Amgen's studies did not fully comply with the requirements of the written request: for one of the studies, the written request required a minimum of fifteen patients ages 28 days to < 6 years, but only four patients completed the study, AR 1645, and, in the FDA's view, Amgen's data did not yield “clinically meaningful” information on cinacalcet's safety in that age group-a key objective of the written request, AR 1647-48. Amgen brought this action under the Administrative Procedure Act, 5 U.S.C. § 701 et seq., to challenge the FDA's denial of pediatric exclusivity for Sensipar. Dkt. 1 at 2 (Compl. ¶ 1). Both parties moved for summary judgment.

         On January 26, 2018, the Court issued a memorandum opinion and order resolving most of Amgen's claims in the FDA's favor. Amgen, 2018 WL 581006, at *21. But the Court granted summary judgment in favor of Amgen on the limited ground that the FDA had failed to offer a “reasoned explanation” for why it reached a “disparate outcome[]” in the case of Johnson & Johnson's Ortho Tri-Cyclen. Id. The written request for Ortho Tri-Cyclen required Johnson & Johnson to complete a study involving at least 120 adolescent women with anorexia nervosa as defined by the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (“DSM-IV”). AR 1872. Johnson & Johnson received pediatric exclusivity in December 2003. AF.2d 4. More than a year later, however, a clinical reviewer for the FDA, Dr. Brenda Gierhart, concluded that “the majority of the 123 subjects treated . . . did not meet . . . the DSM-IV diagnostic criteria for anorexia nervosa.” AR 1916. Relying on this observation, Amgen asserted that it was arbitrary and capricious for the FDA to deny pediatric exclusivity for Sensipar after granting that benefit to another sponsor that neither met the terms of the written request nor achieved its objectives. Dkt. 60-1 at 45.

         The Court concluded that, because the FDA's administrative determination did not “explain [its] rationale and [did not] identify the relevant evidence, ” the Sensipar decision was “at least in this one respect . . . arbitrary and capricious.” Amgen, 2018 WL 581006, at *17. But the Court also noted that “[t]here may be an answer to Amgen's contention, ” including, for instance, that “Johnson & Johnson's study did, in fact, comply with the requirement[s]” of the written request, or that the FDA granted Johnson & Johnson pediatric exclusivity “based on the mistaken belief that [the study] was conducted in full compliance with the terms of the written request” and “the failure to enroll patients meeting the DSM-IV criteria was discovered only after the fact.” Id. The Court, accordingly, remanded the case to the FDA “for the limited purpose of addressing whether the agency's prior decision granting pediatric exclusivity for Ortho Tri-Cyclen is consistent with its decision denying pediatric exclusivity for Sensipar and, if not, whether there is a reasoned explanation for the disparate outcomes.” Id. at *21.

         The FDA issued its Remand Decision and supplemented the administrative record on February 5, 2018. See Remand Decision. The FDA explained in its Remand Decision that it granted pediatric exclusivity to Ortho Tri-Cyclen based on the agency's understanding in December 2003, when it was statutorily required to make the exclusivity determination, that Johnson & Johnson's studies met the terms of the written request. Id. at 1, 3-4. The FDA cited several internal documents that, it asserted, show that it believed Johnson & Johnson had “fulfill[ed] the terms” of the written request when “eligibility for [pediatric exclusivity] was decided.” Id. at 3. The FDA further explained that “the realization that a majority of enrolled study subjects had not, in fact, met DSM-IV criteria for [anorexia nervosa] came after [Johnson & Johnson's] final study reports had been submitted . . . and evaluated” and “postdates the [exclusivity] decision.” Id. at 4. The agency therefore concluded that it applied the same standard to both Ortho Tri-Cyclen and Sensipar and that Amgen's failure to meet the terms of its written request distinguishes the agency's exclusivity denial for Sensipar from the agency's grant of exclusivity for Ortho Tri-Cyclen. Id. at 4.

         The day after it issued its Remand Decision, the FDA notified the Court that it had discovered an additional document showing that, before the FDA granted pediatric exclusivity for Ortho Tri-Cyclen, it asked Johnson & Johnson whether its study “subjects met the enrollment criteria.” Dkt. 78 at 3. The Court held a status conference the following day. In light of the parties' representations at the status conference, the Court again remanded the case to the FDA to address the relevance of the “newly discovered information” to its Remand Decision and set an expedited briefing schedule. Minute Order (Feb. 7, 2018).

         On February 8, 2018, the FDA issued an addendum to its Remand Decision and further supplemented the administrative record with newly discovered documents relating to its Ortho Tri-Cyclen decision. See Remand Addendum. These documents fill in several holes in the timeline discussed above. First, and most significantly, the medical officer who reviewed the interim Ortho Tri-Cyclen data, Dr. Eric Colman, contacted Johnson & Johnson before he recommended granting exclusivity to ask “whether all of the subjects had Body Mass. Index (BMI) values below the 10th percentile for age.” Id. at 1-2; see AF.3d 7. This benchmark, the FDA explains, provides one way to “fulfill[] one of the DSM-IV criteria.” Remand Addendum at 1 n.5. Second, Johnson & Johnson responded to the FDA's inquiry on December 5 and December 8, 2003-once again, before the FDA granted exclusivity on December 18. Id. at 2; see AF.3d 10-12, 14-18. Johnson & Johnson indicated that 74 out of 123 patients had BMIs above the tenth percentile, and it “provided a rationale that purported to explain why, in [its] opinion, the terms of the [written request] had been met.” Remand Addendum at 2. Third, Dr. Colman “contributed to the annotated Written Request for the Pediatric Exclusivity Board, which concluded . . . that ‘[a]ll patients had a diagnosis of [anorexia nervosa] by DSM-IV criteria.'” Id. (quoting AF.2d 18); see also AF.3d 13. Finally, as noted, Dr. Colman recommended granting exclusivity on the grounds that “the requested study was conducted in agreement with the [w]ritten [r]equest.” AR 1885; see Remand Addendum at 2.

         In light of these new records, the FDA's Remand Addendum “correct[s] a factual inaccuracy in the [original] Remand Decision, ” acknowledging that the “FDA questioned whether subjects met the enrollment criteria before the date of the [e]xclusivity [d]ecision, contrary to what the Remand Decision stated.” Remand Addendum at 1-2. But the new records, in the FDA's view, do not alter its conclusion that it applied the same standard to Sensipar and Ortho Tri-Cyclen. According to the FDA, the Sensipar studies fell short of full compliance with the written request, whereas the “FDA determined that the DSM[-]IV criteria had been met” when it granted exclusivity for Ortho Tri-Cyclen. Id. at 4. Reflecting some uncertainty about what happened, the FDA's Remand Addendum also advances two alternative arguments: (1) that the requirement that study subjects meet the DSM-IV criteria was not, in fact, a requirement at all but a mere recommendation or suggestion, id. at 3; and (2) that “it cannot be entirely ruled out that [the] FDA relied on some other rationale to determine Ortho Tri-Cyclen's eligibility for [exclusivity]” and “[e]ven if [the] FDA were mistaken about whether the enrollment criteria were met . . ., that mistake would not justify making a similar mistake when evaluating other sponsors' studies, ” id. at 4.

         Amgen has now renewed its motion for summary judgment with respect to its claim of inconsistent treatment. See Dkt. 83. It asserts that “there is nothing in the record that explains the [Pediatric Exclusivity] Board's . . . analysis, ” id. at 3, and that the FDA's “current musings are completely implausible in light of the record, ” which shows that a majority of the Ortho Tri-Cyclen subjects “did not meet the specified enrollment criteria, ” id. at 5-6. Amgen further contends that, to the extent the FDA applied different “fairly respond” standards to Sensipar and Ortho Tri-Cyclen, its decision on Ortho Tri-Cyclen “reinvigorates” Amgen's fair notice and retroactive rulemaking arguments. Id. at 8; see Id. at 6-8. The FDA has also renewed its motion for summary judgment. Dkt. 84. The agency contends that it applied the same standard to both applications and that the FDA decided that the Ortho Tri-Cyclen studies “met the enrollment criteria in the [written request] at the time of the [exclusivity] decision.” Id. at 3.

         II. ANALYSIS

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Amgen, as the party challenging the FDA&#39;s exclusivity decision, &ldquo;has the burden of showing that the agency action was &lsquo;arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.&#39;&rdquo; Advocates for Highway & Auto Safety v. Fed. Motor Carrier Safety Admin., 429 F.3d 1136, 1144 (D.C. Cir. 2005) (quoting 5 U.S.C. &sect; 706(2)(A)). &ldquo;The scope of review under the &lsquo;arbitrary and capricious&#39; standard is narrow and a court is not to substitute its judgment for that of the agency.&rdquo; Motor Vehicle Mfrs. Ass&#39;n of U.S., Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983). This rule &ldquo;applies with particular force in a case, like this one, involving scientific analysis and &lsquo;technical expertise.&#39;&rdquo; Nat. Res. Def. Council, Inc. v. Rauch, 244 F.Supp.3d 66, 86 (D.D.C. 2017) (quoting Marsh v. Or. Nat. Res. Council, 490 U.S. 360, 377 (1989)). &ldquo;When specialists express conflicting views, &rdquo; for example, &ldquo;an agency must have discretion to rely on the reasonable opinions of its own qualified experts even if, as an original matter, a court might find contrary views more persuasive.&rdquo; Marsh, 490 U.S. at 378. That said, the Court must satisfy itself that the agency ...

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