Regulating Antibiotics in an Era of Resistance: The Historical Basis and Continued Need for Adequate and Well-Controlled Investigations
Authors: Scott H. Podolsky, John H. Powers
Journal: Annals of Internal Medicine (2015)

Ideas and Opinions1 September 2015Regulating Antibiotics in an Era of Resistance: The Historical Basis and Continued Need for Adequate and Well-Controlled InvestigationsScott H. Podolsky, MD and John H. Powers III, MDScott H. Podolsky, MDFrom Harvard Medical School, Boston, Massachusetts, and George Washington University School of Medicine, Washington, DC.Search for more papers by this author and John H. Powers III, MDFrom Harvard Medical School, Boston, Massachusetts, and George Washington University School of Medicine, Washington, DC.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/M15-0802 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Two bills introduced in Congress (the Promise for Antibiotics and Therapeutics for Health Act and the Antibiotic Development to Advance Patient Treatment Act of 2013 in the 21st Century Cures Act) propose changes in the regulatory approval of new antibiotics in the context of attempts to reengage industry amidst fears of a postantibiotic future. Despite anti-infectives having among the shortest development times and highest approval rates among therapeutic classes (1–3), some propose that the requirements of adequate and well-controlled trials make the study of new antibiotics infeasible (4). 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DeLauro Introduces HEAL Act to Address Antibiotic-Resistant Superbugs [press release]. 2015. Accessed at http://delauro.house.gov/index.php?option=com_content&view=article&id=1822:delauro-introduces-heal-act-to-address-antibiotic-resistant-superbugs&catid=2&Itemid=21 on 8 July 2015. Google Scholar Author, Article, and Disclosure InformationAuthors: Scott H. Podolsky, MD; John H. PowersIII, MDAffiliations: From Harvard Medical School, Boston, Massachusetts, and George Washington University School of Medicine, Washington, DC.Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M15-0802.Corresponding Author: Scott H. Podolsky, MD, Department of Global Health and Social Medicine, Harvard Medical School, 641 Huntington Avenue, Boston, MA 02115.Current Author Addresses: Dr. Podolsky: Department of Global Health and Social Medicine, Harvard Medical School, 641 Huntington Avenue, Boston, MA 02115.Dr. Powers: George Washington University School of Medicine, 2150 Pennsylvania Avenue NW, Washington, DC 20037.Author Contributions: Conception and design: S.H. Podolsky, J.H. Powers.Analysis and interpretation of the data: S.H. Podolsky, J.H. Powers.Drafting of the article: S.H. Podolsky, J.H. Powers.Critical revision of the article for important intellectual content: S.H. Podolsky, J.H. Powers.Final approval of the article: S.H. Podolsky, J.H. Powers.Provision of study materials or patients: S.H. Podolsky, J.H. Powers.Statistical expertise: J.H. Powers.Administrative, technical, or logistic support: S.H. Podolsky, J.H. Powers.Collection and assembly of data: S.H. Podolsky, J.H. Powers.This article was published online first at www.annals.org on 14 July 2015. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetails Metrics Cited byEpistemic Gains and Epistemic Games: Reliability and Higher Order Evidence in Medicine and PharmacologyAntibiotic resistance profiles in Panama: Trends from 2007 to 2013The 2016 Garrod Lecture: The role of the healthcare epidemiologist in antimicrobial chemotherapy—a view from the USANoninferior Antibiotics: When Is “Not Bad” “Good Enough”? 1 September 2015Volume 163, Issue 5Page: 386-388KeywordsAntibioticsDrug regulationDrug safetyDrugsFood and Drug AdministrationForecastingGlobal healthInfectious diseasesPenicillinPopulation statistics ePublished: 1 September 2015 Issue Published: 1 September 2015 Copyright & PermissionsCopyright © 2015 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...