Conflicts of Interest Among Patient and Consumer Representatives to U.S. Food and Drug Administration Drug Advisory Committees
Authors: S. Scott Graham, Daniel J. Card, Seokhoon Ahn, Sang-Yeon Kim, Molly M. Kessler, Michelle K. Olson
Journal: Annals of Internal Medicine (2016)

Letters18 October 2016Conflicts of Interest Among Patient and Consumer Representatives to U.S. Food and Drug Administration Drug Advisory CommitteesS. Scott Graham, PhD, Daniel J. Card, MA, Seokhoon Ahn, PhD, Sang-Yeon Kim, MA, Molly M. Kessler, MA, and Michelle K. Olson, MAS. Scott Graham, PhDFrom University of Wisconsin–Milwaukee, Milwaukee, Wisconsin, and University of Kentucky, Lexington, Kentucky., Daniel J. Card, MAFrom University of Wisconsin–Milwaukee, Milwaukee, Wisconsin, and University of Kentucky, Lexington, Kentucky., Seokhoon Ahn, PhDFrom University of Wisconsin–Milwaukee, Milwaukee, Wisconsin, and University of Kentucky, Lexington, Kentucky., Sang-Yeon Kim, MAFrom University of Wisconsin–Milwaukee, Milwaukee, Wisconsin, and University of Kentucky, Lexington, Kentucky., Molly M. Kessler, MAFrom University of Wisconsin–Milwaukee, Milwaukee, Wisconsin, and University of Kentucky, Lexington, Kentucky., and Michelle K. Olson, MAFrom University of Wisconsin–Milwaukee, Milwaukee, Wisconsin, and University of Kentucky, Lexington, Kentucky.Author, Article, and Disclosure Informationhttps://doi.org/10.7326/L16-0031 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Background: Drug advisory committees provide independent advice to the U.S. Food and Drug Administration (FDA) on policy matters. Committee members are special government employees and are subject to federal employee conflict-of-interest guidelines under 18 U.S.C. § 208 and § 712 (1994). Although these regulations prohibit actual or apparent conflicts of interest, regulatory policy allows waivers to be issued when the participant's expertise is deemed essential to evaluating a specific matter before the advisory committee. The issuance of waivers can be complicated, but the FDA is clear that relevant scientific expertise is a necessary and primary criterion (1). Therefore, patient and ...References1. Ackerly N, Eyraud J. Mazzotta M. Measuring conflict of interest and expertise on FDA advisory committees. 26 October 2007. Accessed at www.fda.gov/oc/advisory/ergcoireport.pdf on 2 February 2013. Google Scholar2. Institute of Medicine. Conflict of Interest in Medical Research, Education, and Practice. Washington, DC: National Academies Pr; 2009. Google Scholar3. Barker KK. Listening to Lyrica: contested illnesses and pharmaceutical determinism. Soc Sci Med. 2011;73:833-42. [PMID: 21840638] doi:10.1016/j.socscimed.2011.05.055 CrossrefMedlineGoogle Scholar4. Segal JZ. The rhetoric of female sexual dysfunction: faux feminism and the FDA. CMAJ. 2015. [PMID: 26283717] CrossrefMedlineGoogle Scholar5. U.S. Food and Drug Administration. Guidance for the public, FDA advisory committee members, and FDA staff on procedures for determining conflict of interest and eligibility for participation in FDA advisory committees. 2008. Accessed at www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM125646.pdf on 15 January 2016. Google Scholar Author, Article, and Disclosure InformationAffiliations: From University of Wisconsin–Milwaukee, Milwaukee, Wisconsin, and University of Kentucky, Lexington, Kentucky.Financial Support: By the University of Wisconsin–Milwaukee Office of Research and College of Letters & ScienceDisclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=L16-0031. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetails Metrics Cited byCharacteristics and conflicts of interests of public speakers at the Psychopharmacologic Drug and Advisory Committee meetings regarding psychiatric drugsFinancial relationships between patient and consumer representatives and the health industry: A systematic reviewPotential Financial Bias From Speakers at US Food and Drug Administration's Bone, Reproductive, and Urologic Drugs Advisory Committee MeetingsA Content Analysis of Patient Advocacy Organization Policies Addressing Institutional Conflicts of InterestHealthcare Rationing Cutoffs and Sorites IndeterminacyPatient organizations and conflict of interestFinancial Conflicts of Interest at FDA Drug Advisory Committee MeetingsFinancial Conflict of Interest and Academic Influence Among Experts Speaking on Behalf of the Pharmaceutical Industry at the US Food and Drug Administration's Oncologic Drugs Advisory Committee MeetingsData and lore in technical communication research 18 October 2016Volume 165, Issue 8Page: 606-607KeywordsArchivesConflicts of interestDisclosureDrug administrationDrug policyDrugsFood and Drug AdministrationPatient advocacy ePublished: 18 October 2016 Issue Published: 18 October 2016 Copyright & PermissionsCopyright © 2016 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...