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Three Essays on Food and Drug Administration's Postmarketing Studies on Prescription Drugs in the United States

Yoon, Nami (2019) Three Essays on Food and Drug Administration's Postmarketing Studies on Prescription Drugs in the United States. Doctoral Dissertation, University of Pittsburgh. (Unpublished)

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With a paradigm shift from an approval-oriented approach to a lifecycle management approach and increasing demand for expedited approvals and drug safety, the importance of postmarketing studies has been emphasized in drug regulatory and policy environment. This change is reflected in the increasing number of postmarketing studies and the passage of Food and Drug Administration (FDA) Amendments Act of 2007 which authorized FDA to require drug sponsors to conduct postmarketing safety studies. On the other hand, some concern that postmarketing studies are getting longer and larger, the cost of postmarketing studies is rising, but those studies might not yield important information on the safety and effectiveness of drugs. Yet, we know little about FDA’s use of postmarketing studies and their value. Study One (chapter 1) examines postmarketing studies established between July 2008 and May 2016. Most noteworthy, there have been no increases in postmarketing studies during this period and that the duration and number of subjects involved have not changed. Study Two (chapter 2) assess the value of postmarketing studies with respect to public health impact as measured by changes in drug labeling. I found that withdrawal or discontinuation of a drug resulting from postmarketing studies is rare and a half of fulfilled postmarketing studies resulted in label changes. Study Three (chapter 3) addresses whether and how the availability of postmarketing study options affects the drug approval process by examining qualitative data from FDA drug advisory committee meeting transcripts and interviews. I found a few statements (3.5% of the transcripts) by advisory committee members indicating that the prospect of postmarketing studies made them more likely to support approval of a specific drug. Interviews with FDA reviewers, former and current advisory committee members, and industry revealed quite divergent views about the influence of the availability of postmarketing studies.


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Item Type: University of Pittsburgh ETD
Status: Unpublished
CreatorsEmailPitt UsernameORCID
Yoon, Naminay14@pitt.edunay140000-0001-7865-6139
ETD Committee:
TitleMemberEmail AddressPitt UsernameORCID
Committee ChairMendeloff, John M.jmen@pitt.edujmen
Committee MemberGellad, Walid
Committee MemberJones, Daniel
Committee MemberKuller, Lewis
Committee MemberSachs, Rachel
Date: 24 September 2019
Date Type: Publication
Defense Date: 24 April 2019
Approval Date: 24 September 2019
Submission Date: 13 August 2019
Access Restriction: 3 year -- Restrict access to University of Pittsburgh for a period of 3 years.
Number of Pages: 411
Institution: University of Pittsburgh
Schools and Programs: Graduate School of Public and International Affairs > Public and International Affairs
Degree: PhD - Doctor of Philosophy
Thesis Type: Doctoral Dissertation
Refereed: Yes
Uncontrolled Keywords: FDA drug postmarketing studies postmarketing requirements commitments PMR PMC regulation
Date Deposited: 24 Sep 2019 15:30
Last Modified: 24 Sep 2022 05:15


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