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Withholding Information on Unapproved Drug Marketing Applications: The Public Has a Right to Know

Published online by Cambridge University Press:  01 January 2021

Extract

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instances whereby applications for new drugs or new indications for existing drugs have been rejected by the agency or withdrawn from consideration, nor does it disclose the agency’s analyses of the data submitted with such applications.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counterpart agencies in Europe and Canada have demonstrated the feasibility of disclosing information on rejected and withdrawn drug marketing applications.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.

Type
Symposium Articles
Copyright
Copyright © American Society of Law, Medicine and Ethics 2017

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References

U.S. Food and Drug Administration, “Consumer Expenditure on FDA Regulated Products: 20 Cents of Every Dollar,” available at <https://blogs.fda.gov/fdavoice/index.php/2016/11/consumer-expenditure-on-fda-regulated-products-20-cents-of-every-dollar/> (last visited November 9, 2017).+(last+visited+November+9,+2017).>Google Scholar
21 C.F.R. 314.430 (c) and (b).Google Scholar
21 U.S.C. §355(l)(1).Google Scholar
FDA Transparency Working Group, Blueprint for Transparency at the U.S. Food and Drug Administration, March 13, 2017, available at <https://www.jhsph.edu/departments/health-policy-and-management/_pdf/FDA_Transparency.pdf> (last visited November 9, 2017). Also published in JLME 45, no. 4, Suppl. (2017) (hereinafter cited as Blueprint).+(last+visited+November+9,+2017).+Also+published+in+JLME+45,+no.+4,+Suppl.+(2017)+(hereinafter+cited+as+Blueprint).>Google Scholar
21 U.S.C. §355(l)(2).Google Scholar
See Blueprint, supra note 4.Google Scholar
U.S. Food and Drug Administration, Transparency Task Force, FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and Drug Administration, May 2010, available at <https://www.fda.gov/downloads/aboutfda/transparency/publicdisclo-sure/glossaryofacronymsandabbreviations/ucm212110.pdf> (last visited November 9, 2017).+(last+visited+November+9,+2017).>Google Scholar
See Blueprint, supra note 4.Google Scholar
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,” March 31, 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).+(last+visited+November+9,+2017).>Google Scholar
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, January 2009, available at <https://www.fda.gov/RegulatoryInformation/Guidances/ucm125126.htm> (last visited November 9, 2017).+(last+visited+November+9,+2017).>Google Scholar
H.R.1703 - Medical Product Communications Act of 2017. Introduced March 23, 2017, available at <https://www.congress.gov/bill/115th-congress/house-bill/1703/text> (last visited November 9, 2017).+(last+visited+November+9,+2017).>Google Scholar
Lurie, P., Chahal, H. S., Sigelman, D. W., Stacy, S., Sclar, J., and Ddamulira, B., “Comparison of Content of FDA Letters Not Approving Applications for New Drugs and Associated Public Announcements from Sponsors: Cross Sectional Study,” BMJ 350 (2015): h2758.Google Scholar
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 (April 18, 1979), available at <https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/> (last visited November 9, 2017).+(last+visited+November+9,+2017).>Google Scholar
Turner, E. H., Matthews, A. M., Linardatos, E., et al., “Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy,” New England Journal of Medicine 358, no. 3 (2008): 252260; Roest, A. M., de Jonge, P., Williams, C. D., 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 Psychiatry 72, no. 5 (2015): 500–510.CrossRefGoogle Scholar
Official Journal of the European Union, Regulation (EC) No 726/2004 of the European Parliament and of the Council, at Article 12(3), available at <http://eur-lex.europa.eu/Lex-UriServ/LexUriServ.do?uri=OJ:L:2004:136:0001:0033:en:PDF> (last visited November 9, 2017).+(last+visited+November+9,+2017).>Google Scholar
Id., at Article 11.Google Scholar
European Medicines Agency, European Public Assessment Reports: Background and Context, available at <http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/general/general_content_000433.jsp&mid=WC0b01ac058067fa25> (last visited November 9, 2017).+(last+visited+November+9,+2017).>Google Scholar
European Medicines Agency, European Public Assessment Reports, available at <http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp&mid=WC0b01ac058001d125> (last visited November 9, 2017).+(last+visited+November+9,+2017).>Google Scholar
Health Canada, Notice: Regulatory Decision Summaries and Submissions under Review, March 13, 2015, available at <http://www.hc-sc.gc.ca/dhp-mps/prodpharma/rds-sdr/drug-med/rds-sur-notice-phasei-avis-sdr-pce-eng.php> (last visited November 9, 2017).+(last+visited+November+9,+2017).>Google Scholar
Health Canada, “The Drug and Health Product Register,” available at <https://hpr-rps.hres.ca/reg-content/regulatory-decision-summary.php> (last visited November 9, 2017).+(last+visited+November+9,+2017).>Google Scholar
U.S. Food and Drug Administration, Transparency Task Force, FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and Drug Administration (May 2010), available at <https://www.fda.gov/downloads/aboutfda/transparency/publicdisclo-sure/glossaryofacronymsandabbreviations/ucm212110.pdf> (last visited November 9, 2017).+(last+visited+November+9,+2017).>Google Scholar