Seife v. U.S. Dep't of Health & Human Servs.

Decision Date24 February 2020
Docket Number18 Civ. 11462 (NRB)
Citation440 F.Supp.3d 254
Parties Charles SEIFE and Peter Lurie, Plaintiffs, v. U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES; Alex M. Azar II, Secretary of Health and Human Services, in his official capacity; National Institutes of Health; Francis S. Collins, Director of the National Institutes of Health, in his official capacity; U.S. Food and Drug Administration; and Scott Gottlieb, Commissioner of Food and Drugs, in his official capacity, Defendants.
CourtU.S. District Court — Southern District of New York

David A. Schulz, Ballard Spahr LLP, Jason Michael Schultz, Washington Square Legal Services, Christopher John Morten, New York University School of Law, New York, NY, John Langford, Protect Democracy, Los Angeles, CA, for Plaintiffs.

Joseph Nicholas Cordaro, Jennifer Ann Jude, United States Attorney's Office, New York, NY, for Defendants.

MEMORANDUM AND ORDER

NAOMI REICE BUCHWALD, UNITED STATES DISTRICT JUDGE

The U.S. Department of Health and Human Services ("HHS"), Secretary of Health and Human Services Alex M. Azar II, the National Institutes of Health ("NIH"), Director of NIH Francis S. Collins, the U.S. Food and Drug Administration (the "FDA"), and Commissioner of Food and Drugs Stephen M. Hahn1 (collectively, "defendants") move to dismiss the complaint of Charles Seife and Peter Lurie (together, "plaintiffs"), or, in the alternative, for summary judgment. Plaintiffs cross-move for summary judgment. Defendants' motion to dismiss is granted in part and denied in part. Defendants' motion for summary judgment is granted in part and denied in part. Plaintiffs' cross-motion for summary judgment is granted in part and denied in part.

I. BACKGROUND
A. Statutory Background

In 1997, Congress enacted the Food and Drug Administration Modernization Act ("FDAMA"). Among other things, FDAMA provided that "[t]he Secretary[2 ], acting through the Director of NIH, shall establish, maintain, and operate a data bank of information on clinical trials for drugs for serious or life-threatening diseases and conditions." 42 U.S.C. § 282(i)(1)(A). It also required the Secretary to "disseminate such information through information systems ... available to individuals with serious or life-threatening diseases and conditions, to other members of the public, to health care providers, and to researchers." Id. § 282(i)(2). Pursuant to these directives, HHS and NIH created ClinicalTrials.gov, an online clinical trial database made publicly accessible in 2000. Joint Stipulation ("Stip.") ¶ 1.

In 2004, Congress raised concerns about the safety and effectiveness of several FDA-approved products for which unfavorable clinical trial results had not been publicly disclosed. Pls.' 56.1 ¶ 7 (citing Declaration of Christopher Morten ("Morten Decl."), Ex. 5 at 66); see also H. Rep. 110-225 at 11-12 (2007). Congress observed that under FDAMA, "negative results may or may not be released by [clinical trial] sponsors," H. Rep 110-225 at 12, and it questioned whether, as a result, clinical trial sponsors were misleading the public about the safety and efficacy of their drugs and devices by publishing only favorable clinical trial results on ClinicalTrials.gov, see id. at 11-12. Congress also expressed misgivings about ClinicalTrials.gov hosting information for clinical trials relating to serious or life-threatening diseases and conditions only. See id. at 12.

To address these concerns, Congress enacted Section 801 of the Food and Drug Administration Amendments Act of 2007, codified as 42 U.S.C. § 282(j) (the "FDAAA"), which sought to "increase the availability of information to the public" and to "communicate the risks and benefits of drugs" in order to "help patients, providers, and researchers learn new information and make more informed healthcare decisions." H. Rep. 110-225 at 12.

To accomplish these goals, the FDAAA defined a broad set of "applicable clinical trials"3 ("ACTs") for which "responsible parties"4 must submit certain clinical trial registration information, see 42 U.S.C. § 282(j)(2)(A)(ii), and clinical trial results information, see, e.g., id. § 282(j)(3)(C), that HHS, acting through NIH, must include on ClinicalTrials.gov, id. § 282(j)(2)(A)(i). The FDAAA also established various enforcement mechanisms to ensure that responsible parties comply with their obligations under the statute. See, e.g., id. §§ 282(j)(5)(C)(ii), 282(j)(5)(E)(i).

1. Clinical Trial Registration Information

Under the FDAAA, responsible parties must submit certain registration information within 21 days after the first patient enrolls in an ACT. See 42 U.S.C. § 282(j)(2)(A)(ii). The registration information includes "descriptive information" (e.g., "a brief summary, intended for the lay public" and "the primary disease or condition being studied"), "recruitment information" (e.g., "eligibility criteria" and "whether the trial accepts healthy volunteers"), "location and contact information" (e.g., "the name of the sponsor" and "the responsible party"), and certain "administrative data." Id.

2. Clinical Trial Results Information

The FDAAA also mandates that responsible parties submit, and defendants include on ClinicalTrials.gov, clinical trial results information. See 42 U.S.C. § 282(j)(3)(B). In this regard, the FDAAA distinguishes between two types of results: Basic Results and Expanded Results. Compare id. § 282(j)(3)(C) (describing Basic Results) with id. § 282(j)(3)(D)(iii) (describing Expanded Results).

2.1 Basic and Expanded Results

Basic Results consist of four categories of information. See id. § 282(j)(3)(C). First, they include demographic and baseline characteristics of the ACT's patient sample, including the number of patients who dropped out or were excluded from the trial analysis. Id. § 282(j)(3)(C)(i). Second, they incorporate primary and secondary outcomes, including tests for the statistical significance of such outcomes. Id. § 282(j)(3)(C)(ii). NIH describes outcomes as "planned measurement[s] ... used to determine the effect of an intervention/treatment on participants," and notes that primary outcomes are "the most important for evaluating the effect of an intervention/treatment." Morten Decl., Ex. 6 at 12. Third, Basic Results include a point of contact for scientific information about the ACT's results. 42 U.S.C. § 282(j)(3)(C)(iii). Fourth, Basic Results encompass whether there is an agreement between the sponsor and the principal investigator that restricts the principal investigator's ability to discuss or publish the ACT's results after its completion. Id. § 282(j)(3)(C)(iv).

Expanded Results also consist of four categories of information. See id. § 282(j)(3)(D)(iii). They include a summary of the ACT and its results "that is written in non-technical, understandable language," as well as one "that is technical in nature," but, in either case, only "if the Secretary determines that such types of summary can be included without being misleading or promotional." Id. § 282(j)(3)(D)(iii)(I)-(II). They also encompass the ACT's protocol, and "[s]uch other categories as the Secretary determines appropriate." Id. § 282(j)(3)(D)(iii)(III)-(IV).

2.2 Requirements for Basic Results

The FDAAA requires HHS to include Basic Results for certain ACTs on ClinicalTrials.gov:

[T]he Secretary shall include in [ClinicalTrials.gov] for each [ACT] for a drug that is approved under [ 21 U.S.C. § 355 ] or licensed under [ 42 U.S.C. § 262 ] or a device that is cleared under [ 21 U.S.C. § 360(k) ] or approved under [ 21 U.S.C. §§ 360e or 360j(m) ], the following elements: [Basic Results].

42 U.S.C. § 282(j)(3)(C). To enable HHS to do this, the FDAAA mandates that "the responsible party ... submit to the Director of NIH for inclusion in [ClinicalTrials.gov] the clinical trial information described in subparagraph (C) [i.e., Basic Results] not later than 1 year, or such other period as may be provided by regulation ... after the earlier of" the ACT's estimated or actual completion date. Id. § 282(j)(3)(E)(i).

Consistent with ensuring public access to clinical trial results for FDA-approved products5 , the FDAAA addressed the situation where an ACT studied a product that was approved after, rather than before, the ACT's estimated or actual completion date:

With respect to an [ACT] that is completed before the drug is initially approved under [ 21 U.S.C. § 355 ] or initially licensed under [ 42 U.S.C. § 262 ], or the device is initially cleared under [ 21 U.S.C. § 360(k) ] or initially approved under [ 21 U.S.C. §§ 360e or 360j(m) ], the responsible party shall submit to the Director of NIH for inclusion in [ClinicalTrials.gov] the clinical trial information described in subparagraphs (C) [i.e., Basic Results] and (D) [i.e., Expanded Results] not later than 30 days after the drug or device is approved under [ 21 U.S.C. § 355 ], licensed under [ 42 U.S.C. § 262 ], cleared under [ 21 U.S.C. § 360k ], or approved under [ 21 U.S.C. §§ 360e or 360j(m) ], as applicable.

42 U.S.C. § 282(j)(3)(E)(iv). Such ACTs are common because federal law generally requires that the FDA review the results of at least one, and sometimes two or more, ACTs before approving a product. See, e.g., 21 U.S.C. § 355(b)(1)(A) (requiring applications for approval of new drugs to include clinical trial results); id. § 360e(c)(1)(A) (requiring the same for premarket approval applications for Class III devices).

2.3 Requirements for Expanded Results

Whereas the FDAAA requires that ClinicalTrials.gov include Basic Results for any ACT of a product that is approved, it delegated authority to HHS to promulgate regulations governing the inclusion of Expanded Results. See 42 U.S.C. § 282(j)(3)(D)(i).

Under the FDAAA, the regulations that HHS promulgates must require ClinicalTrials.gov to include Expanded Results for each ACT of a product that is approved: "[t]he regulations under this subparagraph shall require the inclusion of the results information described in clause (iii) [i.e., Expanded Results] for...

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