Market withdrawal of new molecular entities approved in the United States from 1980 to 2009
Article first published online: 14 MAY 2011
Copyright © 2011 John Wiley & Sons, Ltd.
Pharmacoepidemiology and Drug Safety
Volume 20, Issue 7, pages 772–777, July 2011
How to Cite
Qureshi, Z. P., Seoane-Vazquez, E., Rodriguez-Monguio, R., Stevenson, K. B. and Szeinbach, S. L. (2011), Market withdrawal of new molecular entities approved in the United States from 1980 to 2009. Pharmacoepidem. Drug Safe., 20: 772–777. doi: 10.1002/pds.2155
- Issue published online: 28 JUN 2011
- Article first published online: 14 MAY 2011
- Manuscript Accepted: 25 MAR 2011
- Manuscript Revised: 21 MAR 2011
- Manuscript Received: 7 JUL 2010
- Drug discontinuation;
- drug market withdrawal;
- drug safety;
- new drug approval;
- biological license;
- drug development
Economic factors, market dynamics, and safety issues are largely responsible for decisions to withdraw pharmaceutical products from the market. In this study, new molecular entities (NMEs) approved by the Food and Drug Administration (FDA) were examined in the USA from 1980 to 2009.
Data were obtained from the FDA, Micromedex, Medline, and Lexis-Nexis. Descriptive analyses were used to classify product discontinuations by therapeutic category, time frame for discontinuation, and reason for withdrawal.
There were 740 NMEs approved by the FDA during the study period. As of 1 December 2010, the number of drugs discontinued was 118 (15.9%). Discontinuations were the highest for antiparasitic products, insecticides, and repellents (6, 33.3% of approvals), systemic hormonal preparations excluding sex hormones and insulins (5, 33.3%), musculo-skeletal system (11, 32.4%), diagnostic agents (16, 28.1%), and anti-infectives for systemic use (27, 25.2%). Safety was the primary reason for withdrawing 26 drugs (3.5% of approvals).
Approximately one in seven approved NMEs were discontinued from the market in the period of 1980–2009. Less than one-quarter (22%) of the total withdrawals were attributed to safety reasons. An ongoing evaluation of new drugs throughout their product life cycle is important to determine their efficacy, safety, and value to society. Copyright © 2011 John Wiley & Sons, Ltd.