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Seife v. United States HHS

United States District Court for the Southern District of New York

February 24, 2020, Decided; February 24, 2020, Filed

18 Civ. 11462 (NRB)

Opinion

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 [*2]  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 Secretary2 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 [*3]  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.

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2020 U.S. Dist. LEXIS 31486 *; 2020 WL 883478

CHARLES SEIFE and PETER LURIE, Plaintiffs, - against - 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.

CORE TERMS

notice, clinical, FDA, ClinicalTrials, pre-approval, noncompliance, licensed, pre-Rule, deference, eteplirsen, patients, abdication, inaction, retroactivity, unambiguously, promulgated, misleading, sponsor, nonenforcement, omadacycline, registration, inclusion, quotation, concrete, efficacy, preamble, canon, discretionary, notification, traceability