Amgen Inc. v. Hargan

Decision Date26 January 2018
Docket NumberCivil Action No. 17–1006 (RDM)
Citation285 F.Supp.3d 351
Parties AMGEN INC., Plaintiff, v. Eric D. HARGAN, Acting Secretary, Department of Health and Human Services, et al., Defendants, and Teva Pharmaceuticals USA, Inc., et al., Intervenor–Defendants.
CourtU.S. District Court — District of Columbia

Catherine Emily Stetson, Susan Margaret Cook, Hogan Lovells U.S. LLP, Washington, DC, for Plaintiff.

Charles John Biro, U.S. Department of Justice, Washington, DC, for Defendants.

Douglas B. Farquhar, Hyman, Phelps & McNamara, P.C., William M. Jay, Brian Burgess, Prescott Moore Lassman, Goodwin Procter, LLP, Washington, DC, Joshua James Bone, Goodwin Procter LLP, Boston, MA, for IntervenorDefendants.

MEMORANDUM OPINION AND ORDER

RANDOLPH D. MOSS, United States District Judge

To encourage pharmaceutical companies to study the safety and effectiveness of pediatric uses of drugs approved for adults, the Federal Food, Drug, and Cosmetic Act ("FFDCA") grants six months of "pediatric exclusivity" to the sponsor of a brand-name drug if the sponsor conducts studies that "fairly respond" to a "written request" from the Food and Drug Administration ("FDA"). 21 U.S.C. § 355a(d)(4). At the urging of Plaintiff Amgen Inc., the FDA issued a written request asking that Amgen conduct pediatric studies of its drug Sensipar

(cinacalcet hydrochloride), and Amgen endeavored to fulfill the request. Ultimately, however, the FDA found that Amgen had failed to complete a study on the safety of cinacalcet hydrochloride in children ages 28 days to "fairly respond" to the written request. The FDA, accordingly, denied Amgen's request for pediatric exclusivity. Subsequently, the FDA denied both Amgen's request for reconsideration and its appeal of that decision.

Amgen challenges the FDA's decision as well as the agency's underlying interpretation of the "fairly respond" requirement. The matter is now before the Court on Amgen's motion for summary judgment, Dkt. 60, and cross-motions for summary judgment filed by the FDA, Dkt. 65, and four intervenor-defendants, Dkt. 63. For the reasons that follow, the Court will DENY in part and GRANT in part Amgen's motion and will DENY in part and GRANT in part the FDA's and the intervenor-defendants' cross-motions for summary judgment.

I. BACKGROUND
A. Statutory Background

A manufacturer seeking to market a new drug in the United States must first obtain approval from the FDA. The approval process is both time-consuming and expensive. Among other things, the applicant—or "sponsor"—must submit a new drug application ("NDA") containing the extensive data and information necessary to demonstrate that the new—or "pioneer"—drug is "safe" and "effective," 21 U.S.C. § 355(b)(1), as well as a "certification" relating to each patent that claims the drug or a use of the drug, 21 U.S.C. § 355(b)(2).

The Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98–417, 98 Stat. 1585—popularly known as the Hatch–Waxman Act—created an alternative path for manufacturers of generic drugs. Instead of submitting its own clinical data on safety and efficacy, a generic manufacturer may submit an abbreviated new drug application ("ANDA") showing that the generic version of the drug contains the same active ingredient as the pioneer drug and is "bioequivalent" to that drug. 21 U.S.C. § 355(j) ; see AstraZeneca Pharm. LP v. FDA , 713 F.3d 1134, 1136 (D.C. Cir. 2013) ("ANDAs need not include new clinical studies demonstrating ... safety or efficacy, but must propose the same basic labeling as approved for the pioneer drug."). In creating this shortcut, Congress sought to encourage "the development of generic drugs to increase competition and lower prices." Amarin Pharm. Ireland Ltd. v. FDA , 106 F.Supp.3d 196, 198 (D.D.C. 2015). But, at the same time, Congress recognized that it needed to maintain "incentives for pharmaceutical companies to invest in innovation and the creation of new drugs." Id. Accordingly, Congress "provided increased intellectual property rights and periods of market exclusivity for those pioneer manufacturers that invent new drugs." Id. ; see also 21 U.S.C. § 355(j)(5)(F) ; AstraZeneca , 713 F.3d at 1136. After the period of marketing exclusivity ends, however, the FDA may ordinarily approve ANDAs, thus authorizing the marketing of competing, generic versions of the pioneer drug. AstraZeneca , 713 F.3d at 1136 ; see 21 U.S.C. § 355(j).

Although this statutory scheme proved successful in encouraging generic competition while maintaining the impetus to innovate, it failed to provide sufficient incentives for drug companies to conduct research on the effects of new drugs on children. In 1997, Congress found that the pharmaceutical industry had "studied and labeled for use in children" only a small portion of the drugs on the market, even though "children suffer from many of the same diseases as adults and are often treated with the same medicines." S. Rep. No. 107–79, at 3–4 (2001). After looking for the cause of this lack of pediatric research, Congress concluded that "there [was] little incentive for drug sponsors to perform studies for medications which they intend to market primarily for adults and [the] use [of which] in children is expected to generate little additional revenue." Id. at 4 (quoting S. Rep. No. 104–284 (1996) ). The absence of information on pediatric drug safety and efficacy, moreover, exposed children to a number of unique risks:

Dosing children based merely on their lower weight is often imprecise, since their bodies can metabolize medicines differently than adults. Some drugs may have different adverse side effects or toxicities in children than in adults, so estimating dosages for children from dosages found to be safe and effective in adults may not be appropriate. The lack of pediatric studies and labeling information may lead to unintended medical errors and place children at risk of being under-dosed or overdosed with medication. The lack of age-appropriate formulations (e.g., liquid form) can also make it difficult to give children and infants prescribed amounts of a needed medication.

Id. at 3.

To address this problem, Congress enacted a "pediatric exclusivity" statute. See Food and Drug Administration Modernization Act of 1997, Pub. L. No. 105–115, § 111, 111 Stat. 2296, 2305–09; Best Pharmaceuticals for Children Act, Pub. L. No. 107–109, 115 Stat. 1408 (2002); see also Mylan Labs., Inc. v. Thompson , 389 F.3d 1272, 1276 (D.C. Cir. 2004). Under that law, a drug sponsor that receives "pediatric exclusivity" is entitled to an additional six months of market exclusivity. AR 1390. This protection, moreover, is sweeping; it applies to all "products containing the active moiety that has existing patent protection or exclusivity,"1 and it applies both to patent rights and to the FDA's authority to approve ANDAs for competing products. Id.

Five events must occur for a sponsor to qualify for pediatric exclusivity: (1) the FDA must determine "that information relating to the use of [the] drug in the pediatric population may produce health benefits in that population;" (2) the FDA must make a "written request for pediatric studies;" (3) the applicant must agree to that request; (4) the studies must be "completed using appropriate formulations for each age group for which the study is requested within [the specified] timeframe;" and—most importantly for present purposes—(5) the reports from those studies must be "submitted [to] and accepted " by the FDA. 21 U.S.C. § 355a(b)(1) (emphasis added). A sponsor may ask the FDA to issue a written request by filing "a proposed pediatric study request" ("PPSR"). 21 U.S.C. § 355a(d)(3). Before issuing the written request, the FDA must consult with the sponsor, 21 U.S.C. § 355a(d)(1)(A), and submit the request for review by the Pediatric Review Committee, 21 U.S.C. § 355a(f)(1), (2). That committee includes experts in, among other fields, pediatrics, biopharmacology, chemistry, and "the appropriate expertise pertaining to the pediatric product under review." 21 U.S.C. § 355d. When issued, the written request asks the sponsor to "conduct pediatric studies" within a certain timeframe and to "propose pediatric labeling resulting from such studies." 21 U.S.C. § 355a(d)(1)(A).

The written request "serves as a yardstick against which the sponsor's eligibility for pediatric exclusivity is later measured." Dkt. 65–1 at 16. As the FDA explains, "[g]iven the breadth of the benefit available to sponsors who qualify for pediatric exclusivity, the agency generally asks for a full range of studies designed to provide meaningful information regarding use of the drug in all of the pediatric populations in which the drug is likely to be used." Id. at 15–16. The written request also includes "specific details regarding study design and endpoints, [the] number of patients to be studied, and study duration." Id. at 16.

After the sponsor completes the studies and submits its reports, the FDA is required to decide within 180 days whether to "accept or reject such reports." 21 U.S.C. § 355a(d)(4). The FDA must accept the reports if the sponsor's studies satisfy the three exclusive conditions set forth in the statute. In the words of the statute:

The Secretary's only responsibility in accepting or rejecting the reports shall be to determine, within the 180–day period, whether the studies [1] fairly respond to the written request, [2] have been conducted in accordance with commonly accepted scientific principles and protocols, and [3] have been reported in accordance with the requirements of the Secretary for filing.

Id. (emphasis added). The Pediatric Review Committee may review the studies for purposes of making a recommendation on whether the FDA should accept or reject the reports, but it is not required to do so. 21 U.S.C. § 355a(f)(3).

B. Regulatory Background

This case turns on the meaning of the "fairly respond" requirement, and, it is fair to say, the FDA's...

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