Why trash don’t pass? pharmaceutical licensing and safety performance of drugs
Tannista Banerjee () and
Arnab Nayak ()
Additional contact information
Tannista Banerjee: Auburn University
Arnab Nayak: Mercer University
The European Journal of Health Economics, 2017, vol. 18, issue 1, No 6, 59-71
Abstract This paper examines how asymmetric information in pharmaceutical licensing affects the safety standards of licensed drugs. Pharmaceutical companies often license potential drug molecules at different stages of drug development from other pharmaceutical or biotechnology companies and complete the remaining of research stages before submitting the new drug application(NDA) to the food and drug administration. The asymmetric information associated with the quality of licensed molecules might result in the molecules which are less likely to succeed to be licensed out, while those with greater potential of success being held internally for development. We identify the NDAs submitted between 1993 and 2004 where new molecular entities were acquired through licensing. Controlling for other drug area specific and applicant firm specific factors, we investigate whether drugs developed with licensed molecules face higher probability of safety based recall and ultimate withdrawal from the market than drugs developed internally. Results suggest the opposite of Akerlof’s (Q J Econ 84:488–500, 1970) lemons problem. Licensed molecules rather have less probability of facing safety based recalls and ultimate withdrawal from the market comparing to internally developed drug molecules. This suggests that biotechnology and small pharmaceutical firms specializing in pharmaceutical research are more efficient in developing good potential molecules because of their concentrated research. Biotechnology firms license out good potential molecules because it increases their market value and reputation. In addition, results suggest that both the number of previous approved drugs in the disease area, and also the applicant firms’ total number of previous approvals in all disease areas reduce the probability that an additional approved drug in the same drug area will potentially be harmful.
Keywords: Pharmaceutical licensing; Asymmetric information; Quality; Food and drug administration; L24; L65 (search for similar items in EconPapers)
References: View references in EconPapers View complete reference list from CitEc
Citations: Track citations by RSS feed
Downloads: (external link)
http://link.springer.com/10.1007/s10198-015-0758-x Abstract (text/html)
Access to the full text of the articles in this series is restricted.
This item may be available elsewhere in EconPapers: Search for items with the same title.
Export reference: BibTeX
RIS (EndNote, ProCite, RefMan)
Persistent link: https://EconPapers.repec.org/RePEc:spr:eujhec:v:18:y:2017:i:1:d:10.1007_s10198-015-0758-x
Ordering information: This journal article can be ordered from
http://www.springer. ... cs/journal/10198/PS2
Access Statistics for this article
The European Journal of Health Economics is currently edited by J.-M.G.v.d. Schulenburg
More articles in The European Journal of Health Economics from Springer, Deutsche Gesellschaft für Gesundheitsökonomie (DGGÖ) Contact information at EDIRC.
Bibliographic data for series maintained by Sonal Shukla ().