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Market Discontinuation of Pharmaceuticals in the United States

Qureshi, Zaina Parvez

Abstract Details

2009, Doctor of Philosophy, Ohio State University, Pharmacy.
The pharmaceutical industry serves societal needs by bringing innovative products and therapies to market. However, innovation does not guarantee market longevity. Consequently, some products are evaluated and considered for market discontinuation. Safety, efficacy, and financial concerns are important considerations when evaluating the reasons for market discontinuation of drugs. In this study, market discontinuation of new molecular entities (NMEs) approved by the FDA from 1980 to 2008 were analyzed. The independent variables considered for the analysis were drug characteristics (route of administration, therapeutic class), sponsor characteristics (sponsor country, sponsor with single NME during study period), drug policy (orphan drug status, accelerated review, priority review and Prescription Drug User Fee Act (PDUFA) enactment). Data were derived from the FDA, Micromedex, Medline, Lexis-Nexis and Medicaid Drug Utilization Data. A drug was considered discontinued if it was deleted from the FDA's Orange book. Withdrawals of approval were also included in the study. Descriptive statistics, chi-square tests, logistic regression and survival analysis were performed for the study. A total of 703 NMEs were approved during the study period. In December 31, 2008, 71.8% NMEs remained in the market; 14.4% were discontinued; 5.4% NMEs had the brand discontinued, but the generic was available; 7.0% had changes in route, dosage form or strength; 0.7% were never marketed and 0.9% were over-the-counter drugs. Safety was the primary reason for withdrawal of 29 (27.4%) NMEs; 4 (3.8%) NMEs had Federal Register determination for not being discontinued for safety or efficacy reasons; 5 NMEs were never marketed (4.7%) and 68 (64.2%) had no reasons stated by the FDA. Compared to other classes anti-infectives were more likely (p<0.05) to be discontinued. Analyses of priority review, orphan drug status, and sponsor company's country (US or non-US) with respect to market withdrawal were not significant. Comparisons of pharmaceuticals withdrawn due to safety reasons with therapeutic class and implementation of PDUFA were also not significant. One in seven NMEs approved during the study period were discontinued from the market. Less than one fourth of the discontinuations were due to safety reasons. Obsolescence and financial reasons are significant contributors to market discontinuations. An ongoing evaluation of NMEs in the market place is important to determine which products provide optimal benefits in terms of efficacy, safety, and value compared to other products overall and other products within the same therapeutic class.
Sheryl Szeinbach, PhD, RPh (Advisor)
Enrique Seoane-Vazquez, PhD (Advisor)
Kurt Stevenson, MD, MPH (Committee Member)
196 p.

Recommended Citations

Citations

  • Qureshi, Z. P. (2009). Market Discontinuation of Pharmaceuticals in the United States [Doctoral dissertation, Ohio State University]. OhioLINK Electronic Theses and Dissertations Center. http://rave.ohiolink.edu/etdc/view?acc_num=osu1250572741

    APA Style (7th edition)

  • Qureshi, Zaina. Market Discontinuation of Pharmaceuticals in the United States. 2009. Ohio State University, Doctoral dissertation. OhioLINK Electronic Theses and Dissertations Center, http://rave.ohiolink.edu/etdc/view?acc_num=osu1250572741.

    MLA Style (8th edition)

  • Qureshi, Zaina. "Market Discontinuation of Pharmaceuticals in the United States." Doctoral dissertation, Ohio State University, 2009. http://rave.ohiolink.edu/etdc/view?acc_num=osu1250572741

    Chicago Manual of Style (17th edition)