The Food and Drug Administration (FDA), as a matter of long-standing policy, does not inform the public of instances whereby applications for new drugs or new indications for existing drugs have been rejected by the agency or withdrawn from consideration, nor does it disclose the agency’s analyses of the data submitted with such applications. This lack of transparency is unjustified and prevents patients, researchers, and healthcare providers from gaining insight into why a drug’s application was not approved. The FDA’s policy is particularly troubling in cases where the agency has found a currently marketed drug to be ineffective or unsafe for a newly proposed indication. Disclosure of the FDA’s findings in such cases would promote public health by encouraging healthcare providers to avoid prescribing drugs for unapproved (off-label) uses that the agency has deemed to be potentially dangerous or ineffective. The FDA’s counterpart agencies in Europe and Canada have demonstrated the feasibility of disclosing information on rejected and withdrawn drug marketing applications. The FDA should follow suit and allow the American public to know when a drug is deemed unsafe or ineffective for a certain use.
From 1991 through 2015, a total of 373 settlements were reached between the federal and state governments and pharmaceutical manufacturers, for a total of $35.7 billion. The unlawful promotion of drugs, mostly off-label marketing, was the single violation that resulted in the largest financial penalties. See: Public Citizen, “Twenty-Five Years of Pharmaceutical Industry Criminal and Civil Penalties: 1991 through 2015,”March31, 2016, available at <https://www.citizen.org/our-work/health-and-safety/twenty-five-years-pharmaceutical-industry-criminal-and-civil-penalties-1991-through-2015> (last visited November 9, 2017).
11.
Food and Drug Administration, “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices, January2009, available at <https://www.fda.gov/RegulatoryInformation/Guidances/ucm125126.htm> (last visited November 9, 2017).
P.Lurie, H. S.Chahal, D. W.Sigelman, S.Stacy, J.Sclar, and B.Ddamulira, “Comparison of Content of FDA Letters Not Approving Applications for New Drugs and Associated Public Announcements from Sponsors: Cross Sectional Study,”BMJ350 (2015): h2758.
14.
Department of Health Education and Welfare, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (April18, 1979), available at <https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/> (last visited November 9, 2017).
15.
E. H.Turner, A. M.Matthews, E.Linardatos, et al., “Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy,”New England Journal of Medicine358, no. 3 (2008): 252-260; A. M.Roest, P.de Jonge, C. D.Williams, et al., “Reporting Bias in Clinical Trials Investigating the Efficacy of Second-Generation Antidepressants in the Treatment of Anxiety Disorders: A Report of 2 Meta-analyses,”JAMA Psychiatry72, no. 5 (2015): 500-510.
