Moving the U.S. Food and Drug Administration Forward
Authors: Joel S. Perlmutter
Journal: Annals of Internal Medicine (2021)

EditorialsNovember 2021Moving the U.S. Food and Drug Administration ForwardJoel S. Perlmutter, MDJoel S. Perlmutter, MDWashington University in St. Louis School of Medicine, St. Louis, MissouriAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/M21-3393 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail The mission of the U.S. Food and Drug Administration (FDA) includes "protecting the public health by ensuring the safety, efficacy and security of human and veterinary drugs, biological products … [as well as] advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health" (1). The recent emergency use authorization of COVID-19 vaccines is a prime example of how the FDA can accomplish this mission with amazing care and efficiency.... References1. U.S. Food and Drug Administration. What We Do. Updated 28 March 2018. Accessed at www.fda.gov/about-fda/what-we-do on 15 August 2021. Google Scholar2. U.S. Food and Drug Administration. Food and Drug Administration Modernization Act (FDAMA) of 1997. Updated 29 March 2018. Accessed at www.fda.gov/regulatory-information/selected-amendments-fdc-act/food-and-drug-administration-modernization-act-fdama-1997 on 15 August 2021. Google Scholar3. U.S. Food and Drug Administration. FDA grants accelerated approval for Alzheimer's drug. 7 June 2021. Accessed at www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-drug on 16 August 2021. Google Scholar4. U.S. Food and Drug Administration. Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) meeting minutes. 6 November 2020. Accessed at www.fda.gov/media/145691/download on 16 August 2021. Google Scholar5. Massie T. BLA 761178 statistical review: aducanumab in Alzheimer's. 2020. Accessed at https://collaboration.fda.gov/pradgevcxis7 on 30 August 2021. Google Scholar6. Alexander GC, Knopman DS, Emerson SS, et al. Revisiting FDA approval of aducanumab. N Engl J Med. 2021. [PMID: 34320282] doi:10.1056/NEJMp2110468 CrossrefMedlineGoogle Scholar7. Janiaud P, Irony T, Russek-Cohen E, et al. U.S. Food and Drug Administration reasoning in approval decisions when efficacy evidence is borderline, 2013–2018. Ann Intern Med. 2021;174:1603-11. doi:10.7326/M21-2918 Google Scholar Author, Article, and Disclosure InformationAuthors: Joel S. Perlmutter, MDAffiliations: Washington University in St. Louis School of Medicine, St. Louis, MissouriNote: Dr. Perlmutter resigned on 7 June 2021 from the Peripheral and Central Nervous System Drugs Advisory Committee of the FDA.Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M21-3393.Corresponding Author: Joel S. Perlmutter, MD, Washington University School of Medicine, Campus Box 8111, 660 South Euclid Avenue, St. Louis, MO 63110; e-mail, perlmutterjoel@wustl.edu.This article was published at Annals.org on 21 September 2021. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoU.S. Food and Drug Administration Reasoning in Approval Decisions When Efficacy Evidence Is Borderline, 2013–2018 Perrine Janiaud , Telba Irony , Estelle Russek-Cohen , and Steven N. Goodman Metrics Cited byAnalysis of Adverse Reactions of Aspirin in Prophylaxis Medication Based on FAERS DatabaseImproving Translational Paradigms in Drug Discovery and Development November 2021Volume 174, Issue 11Page: 1626-1627KeywordsDrug policyFood and Drug Administration ePublished: 21 September 2021 Issue Published: November 2021 Copyright & PermissionsCopyright © 2021 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...