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FDA Transparency in an Inescapably Political World

Published online by Cambridge University Press:  01 January 2021

Daniel Carpenter
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Abstract

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.

Type
Symposium Articles
Information
Journal of Law, Medicine & Ethics , Volume 45 , Issue S2: Symposium - Blueprint for Transparency at the U.S. Food and Drug Administration , Winter 2017 , pp. 29 - 32
Copyright
Copyright © American Society of Law, Medicine and Ethics 2017

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References

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 & Ethics 45, no. 4, Suppl. (2017): 7–23.CrossRefGoogle Scholar
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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 Carpenter, D., Greene, J., and Moffitt, S., “The Drug Efficacy Study and Its Manifold Legacies,” in Cohen, I. G. and Lynch, H. F., 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 Carpenter, D. and Tob-bell, D., “Bioequivalence: The Regulatory Career of a Pharmaceutical Concept,” Bulletin of the History of Medicine 85, no. 1 (Spring 2011): 93–131.Google Scholar
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