Transparency requires more than disclosure of data. It requires a mechanism and policy for conveying information to the public. In order for the aims of the excellent report of the FDA Transparency Working Group to be realized, a publicity initiative will need to accompany the plan of action. The FDA will need to actively convey information about the evidence concerning benefit-risk profiles of drugs, sometimes pointing out misleading claims by manufacturers or sponsors. In other cases, the FDA will need to make available its procedures, including possible conflicts of interest, not only in drug approval, but also in guidance documents and in rulemaking. Transparency as a process of letting the public see into the agency should be accompanied by a proactive strategy of distributing information about the products regulated by the agency.
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References
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FDA Transparency Working Group, “Blueprint for Transparency at the U.S. Food and Drug Administration: Recommendations to Advance the Development of Safe and Effective Medical Products,”Journal of Law, Medicine & Ethics45, no. 4, Suppl. (2017): 7-23.
2.
Among the many contributions here, see A. S.Kesselheim and M.Mello, “Confidentiality Laws and Secrecy in Medical Research: Improving Public Access to Data on Drug Safety,”Health Affairs26, no. 2 (2007): 483-491; S. P.Hey and A. S.Kesselheim, “The FDA, Juno Therapeutics and the ethical imperative of transparency,”BMJ354 (2016), available at <http://www.bmj.com/content/354/bmj.i4435> (last visited October 31, 2017).
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A.Fung, M.Graham, and D.Weil, Full Disclosure: The Perils and Promise of Transparency (New York: Cambridge University Press, 2007) (cited over 700 times in Google Scholar, for instance); G.Loewenstein, S.Sah, and D.Cain, “The Unintended Consequences of Conflict of Interest Disclosure,”JAMA307, no. 7 (2012): 669-670. These two publications shed doubt on the efficacy of transparency and disclosure policies. For recent studies concluding that COI disclosures may have more of an effect than previously believed, consultI.Larkin, et al., “Association between Academic Medical Center Pharmaceutical Detailing Policies and Physician Prescribing,”JAMA317, no. 17 (2017): 1785-1795. Either way, it would have been helpful for the transparency authors to have wrestled with the literature.
4.
C.Hood, D.Heald, eds., Transparency: The Key to Better Governance? (New York: Oxford University Press, 2006); A. J.Meijer, “Introduction to the Special Issue on Government Transparency,”International Review of Administrative Sciences78, no. 1 (2012): 3-9. D.Carpenter and D. M.Moss, Preventing Regulatory Capture: Special Interest Influence in Regulation and How To Limit It (New York: Cambridge University Press, 2013); see the Conclusion for a discussion of the role of transparency policy in combating capture.
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G. T.Rubin, “GAO to Probe ‘Regulatory Capture’ at New York Fed,”Wall Street Journal, March4, 2016.
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10.
The best example comes in the Drug Efficacy Study Initiative, which combined a retrospective review of old drug approvals, a confrontation with a number of new classes of therapeutics, and guidance and rule writing on the meaning of the efficacy requirement. See D.Carpenter, J.Greene, and S.Moffitt, “The Drug Efficacy Study and Its Manifold Legacies,” in I. G.Cohen and H. F.Lynch, The FDA in the 21st Century: The Challenges of Regulating Drugs and New Technologies (New York: Columbia University Press, 2015); see also Carpenter, supra note 6, at chapters 5, 7, and 10.Another example in the generic drug domain would come in the development of guidances and new rules for bioequivalence judgments, which were developed at the same time that FDA faced a wave of new generic drug decisions; consult D.Carpenter and D.Tob-bell, “Bioequivalence: The Regulatory Career of a Pharmaceutical Concept,”Bulletin of the History of Medicine85, no. 1 (Spring2011): 93-131.
11.
S. W.Yackee, “Reconsidering Regulatory Capture During Agency Rulemaking,” in Carpenter and Moss, supra note 4. See Carpenter and Tobbell, supra note 10.
12.
Id. (Yackee). For evidence that certain industrial interests benefit from participation in the notice-and-comment process in ways that aggregate to billions of dollars in differential benefit for bank holding companies, consult B.Libgober and D.Carpenter, “Lawyers as Lobbyists: Why Banks Shape Rules,” working paper, Harvard University.
13.
D.Carpenter, “Detecting and Measuring Capture,” in Carpenter and Moss, supra note 4.
A range of conflicting memoranda were published relating to this case. Other procedural aspects of the decision were far less legitimate or desirable. A. S.Kesselheim and J. A.Avorn, “Approval of a Problematic Muscular Dystropy Drug: Implications for FDA Policy,”JAMA316, no. 22 (2016): 2357-2358.
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S. B.Soumerai and J. A.Avorn, “Principles of Educational Outreach (Academic Detailing) to Improve Clinical Decision Making,”JAMA263, no. 4 (1990): 549-556.
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T. J.Hwang, A. S.Kesselheim, D.Carpenter, J. M.Franklin, B.Wang, and J. C.Lauffenberger, “Failure of Investigational Drugs in Late-Stage Clinical Development and Publication of Trial Results,”JAMA-Internal Medicine176, no. 12 (2016): 1826-1833.
