The Blueprint for Transparency at the FDA recommends that the FDA proactively release more clinical trial data. We show that the FDA possesses the legal authority to act on this recommendation, and describe several reasons that the agency should do so. In particular, the primary existing route for researchers to obtain access to this data, the Freedom of Information Act (FOIA), has important limits, as our own recent experience shows.
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References
1.
National Academy of Medicine (NAM), formerly the Institute of Medicine (IoM), Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risks (Washington, D.C.: The National Academies Press, 2015): at 68-69 [hereinafter “IoM Report”].
2.
S.Gottlieb, Answers to Written Questionnaire from Members of the Senate Committee on Health, Education, Labor, and Pensions (April26, 2017): at 58. (“I am a strong proponent of data transparency for patients, physicians, and manufacturers. I have long advocated that the FDA release more information related to its review process … If confirmed, I will be committed to … the issue of data transparency and new ways that FDA could potentially make important information more readily available to the public.”).
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IoM Report, supra note 1.
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Id., at 7 (emphasis added).
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Id.
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L.Chang, S. S.Dhruva, J.Chu, et al., “Selective Reporting in Trials of High Risk Cardiovascular Devices: Cross Sectional Comparison between Premarket Approval Summaries and Published Reports,”BMJ350, no. h2613 (2015), available at <http://www.bmj.com/content/350/bmj.h2613> (last visited November 1, 2017).
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IoM Report, supra note 1, at 32; see, e.g., D.Eyding, M.Lelge-mann, U.Grouven, et al., “Reboxetine for Acute Treatment of Major Depression: Systematic Review and Meta-Analysis of Published and Unpublished Placebo and Selective Serotonin Reuptake Inhibitor Controlled Trials,”BMJ341, no. c4737 (2010), available at <http://www.bmj.com/content/341/bmj.c4737> (last visited November 1, 2017).
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Id., at 110.
9.
IoM Report, supra note 1, at 111.
10.
Id., at 100, 102-103, 105.
11.
Id., at 68-69.
12.
Id., at 7.
13.
Id., at 99 (“The full analyzable data set is generally the most useful set of data to share from a trial, with large and likely important benefits to science and society”); see, e.g., S. E.Nissen and K.Wolski, “Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes,”New England Journal of Medicine356, no. 24 (2007): 2457-2471; Group WARNWDS, “The Effect of Dosing Regimens on the Antimalarial Efficacy of Dihydroartemisinin-Piperaquine: A Pooled Analysis of Individual Patient Data,”PLOS Medicine10, no. 12 (2013): e1001564.
14.
5 U.S.C. § 552 (2017).
15.
U.S. Dep’t of the Air Force v. Rose, 425 U.S. 352, 360-61 (1976) (quoting S.Rep. No. 813, 89th Cong., 1st Sess., 3 (1965)).
16.
5 U.S.C. § 552(b)(4) & (b)(6).
17.
Chrysler Corp. v. Brown, 441 U.S. 281, 293 (1979).
18.
Chrysler Corp., 441 U.S. at 294 (quoting H. R.Rep. No. 1497, 89th Cong., 2d Sess., 2, 5 (1966)); see also Dep’t of the Air Force v. Rose, 425 U.S. at 361 (The FOIA exemptions “do not obscure the basic policy that disclosure, not secrecy, is the dominant objective of the Act,” and thus, they must be “narrowly construed”).
19.
CNA Fin. Corp. v. Donovan, 830 F.2d 1132, 1134 n.1 (D.C. Cir. 1987) (“The agency’s decision to release the data normally will be grounded either in its view that none of the FOIA exemptions applies, and thus that disclosure is mandatory, or in its belief that release is justified in the exercise of its discretion, even though the data fall within one or more of the statutory exemptions.”); see Jurewicz v. U.S. Dep’t of Agriculture, 741 F.3d 1326, 1332 (D.C. Cir. 2014) (finding that a substantial privacy interest “must be balanced against any public interest in disclosure … [to the extent that] disclosure of the information sought would … let citizens know ‘what their government is up to.’”) (quoting U.S. Dep’t of Def. v. Fed. Labor Relations Auth., 510 U.S. 487, 497 (1994)). Where CCI is concerned, however, the balancing of public interests may be inappropriate because the category overlaps with other laws that flatly forbid agencies from making unauthorized disclosures of commercial data. CNA Fin. Corp. v. Donovan, 830 F.2d 1132, 1140 (D.C. Cir. 1987) (finding that 18 U.S.C. § 1905 “appears to cover practically any commercial or financial data collected by any federal employee” such that information that falls under Exemption 4 is barred from disclosure unless otherwise authorized). But, the U.S. Court of Appeals for the Seventh Circuit has suggested a different interpretation — that § 1905 was intended to protect a narrower category of information than Exemption 4, thereby preserving some agency discretion to disclose information that falls within Exemption 4. Gen. Elec. Co. v. U.S. Nuclear Regulatory Comm’n, 750 F.2d 1394, 1402 (7th Cir. 1984) (“Exemption 4 is broadly worded, and it is hard to believe that Congress wanted seekers after information to stub their toes on a rather obscure criminal statute almost certainly designed to protect that narrower category of trade secrets … whose disclosure could be devastating to the owners and not just harmful”).
20.
IoM Report, supra note 1, at 102-103, 108-109, 111.
21.
M. M.Melloet al., “Preparing for Responsible Sharing of Clinical Trial Data,”N. Engl. J. Med.369 (2013): 1651-1658.
22.
IoM Report, supra note 1, at 208-213 (Appendix B) (referring to the de-identification methods provided in the Privacy Rule of the U.S. Health Insurance Portability and Accountability Act (HIPAA) as “a good launching point for examining best practices” for sharing analyzable clinical trial data).
23.
U.S. Dep’t of the Air Force v. Rose, 425 U.S. at 372 (finding that Exemption 6 requires a balancing of the individual’s right to privacy against the public’s right to disclosure under FOIA); Consumers’ Checkbook Ctr. for the Study of Servs. v. U.S. Dep’t of Health and Human Servs., 554 F.3d 1046, 1057 (D.C. Cir. 2009) (stating that FOIA’s “presumption favoring disclosure … is at its zenith under Exemption 6”) (quoting Nat’l Ass’n of Home Builders v. Norton, 309 F.3d 26, 37 (D.C. Cir. 2002)); see also Jurewicz v. U.S. Dep’t of Agriculture, 741 F.3d 1326, 1331-34 (D.C. Cir. 2014) (in reverse-FOIA case, deferring to an agency’s decision that that any personal privacy concerns are minimum and outweighed by the public’s interest “in assessing whether the [agency] is fulfilling its statutory mandate” and “gaug[ing] the effectiveness of [agency] inspections by comparing data … with publicly available inspection reports”).
24.
In 2013, the FDA proposed sharing de-identified analyzable safety and efficacy datasets, acknowledging that such data “have tremendous potential to … provide new opportunities for innovation in medical product development.” “Availability of Masked & Deidentified Non-Summary Safety & Efficacy; Request for Comments,” 78 Federal Register 33421, 33422 (June 3, 2013). More recently, in 2016, the U.S. Department of Health and Human Services has expressed a willingness to explore whether ClinicalTrials.gov can “provide[] the scaffolding on which individual participant data … (the next frontier in transparency) and other trial “meta-data” can be organized in the future,” and the agency “anticipate[s] that ClinicalTrials.gov can be used in the future to catalyze IPD sharing.” “Clinical Trials Registration and Results Submission Final Rule,” 81 Federal Register 64,981, 64,988, 64,991 (Sept. 21, 2016) (codified at 42 C.F.R. Pt. 11).
25.
CNA Fin. Corp. v. Donovan, 830 F.2d 1132 (D.C. Cir. 1987) (finding that 18 U.S.C. § 1905 is “co-extensive” with FOIA’s Exemption 4 for CCI, but holding that the agency’s determination that the information at issue is not CCI to be reasonable); see also Jurewicz v. U.S. Dep’t of Agriculture, 741 F.3d 1326, 1331 (D.C. Cir. 2014) (Exemption 4 “requires a showing of both actual competition and a likelihood of substantial competitive injury … [and the court] will generally defer to the agency’s predictive judgments as to the repercussions of disclosure”) (internal quotations omitted).
26.
IoM Report, supra note 1, at 259-60.
27.
Pub. Citizen Health Research Group v. U.S. Food and Drug Admin., 964 F. Supp. 413 (D.D.C. 1997) (ordering release of post-market study protocols after finding that disclosure would not result in competitive harm); Pub. Citizen Health Research Group v. U.S. Food and Drug Admin., 2000 WL 34262802 (D.D.C. 2000) (holding that CCI claims were vague and ordered release of underlying raw data to a graph with safety information given to an advisory committee); see also Teich v. U.S. Food and Drug Admin., 751 F. Supp. 243, 255 (D.D.C. 1990) (rejecting FDA’s argument that the requested animal studies and consumer complaints are CCI and found that any competitive harm is “negligible”).
U.S. Cong. House. Committee on Energy and Commerce. Subcomittee on Oversight and Investigations, Hearing on Publication and Disclosure Issues in Anti-Depressant Pediatric Clinical Trials September 9, 2004. 108th Cong. 2d sess.: at 27, 35-37, 41, available at <https://www.gpo.gov/fdsys/pkg/CHRG-108hhrg96094/html/CHRG-108hhrg96094.htm> (last visited November 2 2017) (Reps. Deutsch, Bass, and DeGette questioning Dr. Janet Woodcock, then acting Deputy Commissioner of Operations, why the FDA disclosed only the summaries of trials but “not the actual clinical trials” and what Congress can do to “clarify what [the FDA] believe[s] to be the deficiencies in the law that would allow … full disclosure of all these trials.”).
32.
21 U.S.C. § 355(l)(2); FDAAA § 916.
33.
House Committee on Energy and Commerce Committee Hearing, supra note 31; see also Complaint, The People of the State of New York v. GlaxoSmithKline, 401707/2004 (N.Y. Sup. Ct. June 2, 2004), available at <http://news.findlaw.com/wsj/docs/glaxo/nyagglaxo60204cmp.pdf> (last visited November 2, 2017).
34.
Treatment Action Group et al v. U.S. Food & Drug Admin., No. 15-cv-976 (VAB) (D. Conn. Sept. 20, 2016).
35.
5 U.S.C. § 552(a)(3) (all records requested under FOIA that are not exempt must be made “promptly available to any person”); Dep’t of Justice v. Reporters Comm. for Freedom of Press, 489 U.S. 749, 771 (1989) (FOIA is “clearly intended … to give any member of the public as much right to disclosure as one with a special interest”) (quoting NLRB v. Sears, Roe-buck & Co., 421 U.S. 132, 149 (1975)).
36.
See Swan v. SEC, 96 F.3d 498, 500 (D.C. Cir. 1996) (“Once records are released, nothing in FOIA prevents the requester from disclosing the information to anyone else. The statute contains no provisions requiring confidentiality agreements or similar conditions.”); Maricopa Audubon Soc. v. U.S. Forest Serv., 108 F.3d 1082, 1088–89 (9th Cir. 1997) (holding “that FOIA does not permit selective disclosure of information only to certain parties, and that once the information is disclosed … it must also be made available to all members of the public who request it.”)
37.
IoM Report, supra note 1, at 13 (“data use agreements are a promising vehicle for reducing … risks and related disincentives for sharing clinical trial data).
38.
21 C.F.R. § 20.43(a) (permits each FDA department to establish multiple tracks for processing FOIA requests “based on the amount of work and/or time required for a request to be processed”).
39.
Treatment Action Group et al v. U.S. Food & Drug Admin., No. 15-cv-976 (VAB) (D. Conn. Sept. 20, 2016) (ordering FDA to start producing requested data).
40.
U.S. Health and Human Services, HHS Fiscal Year 2015 Freedom of Information Annual Report (Feb. 5, 2016), available at <https://www.hhs.gov/foia/reports/annual-reports/2015/index.html> (last visited November 2, 2017) (under Section VII.C. Processed Requested Granted Expedited Processing); U.S. Food and Drug Administration, Freedom of Information Annual Report FY 2014 (May21, 2015), available at <https://www.hhs.gov/foia/reports/annual-reports/2014/index.html> (last visited November 2, 2017) (under Section VII.C.3. Requests Granted Expedited Processing).
41.
J. S.Ross, J. D.Ritchie, E.Finn, N. R.Desai, R. L.Lehman, H. M.Krumholz, et al., “Data Sharing through an NIH Central Database Repository: A Cross-Sectional Survey of BioLINCC Users,”BMJ Open6, no. 9 (2016): e012769.
