The U.S. Medicine Chest: Implications of Increased Reliance on China
Authors: Rosemary Gibson
Journal: Annals of Internal Medicine (2018)

Ideas and Opinions18 December 2018The U.S. Medicine Chest: Implications of Increased Reliance on ChinaRosemary Gibson, MScRosemary Gibson, MScThe Hastings Center, Garrison, New York (R.G.)Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/M18-2552 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Public concern about the safety of medicines has been heightened with the recent recall of more than half of all valsartan products on the market in the United States and other blood pressure medicines. In the case of valsartan, the U.S. Food and Drug Administration (FDA) identified a probable cancer-causing chemical in the active pharmaceutical ingredient, which was made in China. Changes in the manufacturing process seem to have resulted in the presence of N-nitrosodimethylamine, which may be harmful at very low levels (1).The recall shines a spotlight on the increased reliance of the United States on China to ...References1. U.S. Food and Drug Administration. Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on FDA's ongoing investigation into valsartan impurities and recalls and an update on FDA's current findings. 30 August 2018. Accessed at www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm619024.htm on 5 November 2018. Google Scholar2. Harris G. Drug making's move abroad stirs concern. The New York Times. 19 January 2009. Accessed at www.nytimes.com/2009/01/20/health/policy/20drug.html on 5 November 2018. Google Scholar3. Scott T, Oldenhof C. A 25-year landslide in the manufacture and business of active pharmaceutical ingredients (APIs) in Europe between 1983-2008. European Fine Chemicals Group. Accessed at https://goodslide.org/document/price-and-production-penicillin-exports-pharmaceutical-drug on 5 November 2018. Google Scholar4. U.S. Food and Drug Administration. Information on adverse event reports and heparin. Updated 18 June 2009. Accessed at https://wayback.archive-it.org/7993/20170113124004/http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm112669.htm on 5 November 2018. Google Scholar5. Kishimoto TK, Viswanathan K, Ganguly T, Elankumaran S, Smith S, Pelzer K, et al. Contaminated heparin associated with adverse clinical events and activation of the contact system. N Engl J Med. 2008;358:2457-67. [PMID: 18434646] doi:10.1056/NEJMoa0803200 CrossrefMedlineGoogle Scholar6. U.S. Food and Drug Administration. Transcript of the Science Board meeting. 4 June 2014. Accessed at https://wayback.archive-it.org/7993/20170406193307/https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/ScienceBoardtotheFoodandDrugAdministration/UCM405670.pdf on 5 November 2018. Google Scholar7. U.S. Food and Drug Administration. Warning letter: 320-16-06: Zhejiang Hisun Pharmaceutical Co., Ltd. 31 December 2015. Accessed at www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm480035.htm on 5 November 2018. Google Scholar8. Fink S. Drug shortages forcing hard decisions on rationing treatments. The New York Times. 29 January 2016. Accessed at www.nytimes.com/2016/01/29/us/drug-shortages-forcing-hard-decisions-on-rationing-treatments.html on 5 November 2018. Google Scholar9. Gibson R, Singh J. China Rx: Exposing the Risks of America's Dependence on China for Medicine. Amherst, NY: Prometheus; 2018. Google Scholar Author, Article, and Disclosure InformationAffiliations: The Hastings Center, Garrison, New York (R.G.)Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M18-2552.Corresponding Author: Rosemary Gibson, MSc, The Hastings Center, 21 Malcolm Gordon Road, Garrison, NY 10524; e-mail, [email protected]org.Author Contributions: Conception and design: R. Gibson.Analysis and interpretation of the data: R. Gibson.Drafting of the article: R. Gibson.Critical revision for important intellectual content: R. Gibson.Final approval of the article: R. Gibson.Administrative, technical, or logistic support: R. Gibson.Collection and assembly of data: R. Gibson.This article was published at Annals.org on 11 December 2018. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetails Metrics 18 December 2018Volume 169, Issue 12Page: 873-874KeywordsAntibioticsDisclosureDoxycyclineDrug safetyDrugsFood and Drug AdministrationHeparinPenicillinPrevention, policy, and public healthVeteran care ePublished: 11 December 2018 Issue Published: 18 December 2018 Copyright & PermissionsCopyright © 2018 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...