Open Access. Powered by Scholars. Published by Universities.®
Articles 1 - 2 of 2
Full-Text Articles in Business
Not A Box Of Nuts And Bolts: Distribution Channels For Specialty Drugs?, Liang Xu, Vidya Mani, Hui Zhao
Not A Box Of Nuts And Bolts: Distribution Channels For Specialty Drugs?, Liang Xu, Vidya Mani, Hui Zhao
Research Collection Lee Kong Chian School Of Business
One of the most important trends in the pharmaceutical industry is the rapid growth of specialty drugs. Specialty drugs, mostly bio based, tend to be high risk, high priced, and more regulated than traditional drugs, resulting in unprecedented challenges in distribution. Such challenges lead to the emergence of specialty distributors (SDs), which, compared with traditional wholesalers (WSs), represent a more controlled channel and carry a smaller variety of drugs. Due to the risky nature of specialty drugs, manufacturers must consider the trade-off between access and control in determining whether to use SDs (partially or exclusively). Using a unique dataset assembled …
Inducing Compliance With Postmarket Studies For Drugs Under Fda's Accelerated Approval Pathway, Liang Xu, Hui Zhao, Nicholas C. Petruzzi
Inducing Compliance With Postmarket Studies For Drugs Under Fda's Accelerated Approval Pathway, Liang Xu, Hui Zhao, Nicholas C. Petruzzi
Research Collection Lee Kong Chian School Of Business
Problem definition: In 1992, the Food and Drug Administration (FDA) instituted the accelerated approval pathway (AP) to allow promising drugs to enter the market based on limited evidence of efficacy, thereby permitting manufacturers to verify true clinical benefits through postmarket studies. However, most postmarket studies have not been completed as promised. We address this noncompliance problem. Academic/practical relevance: The prevalence of this noncompliance problem poses considerable public health risk, thus compromising the original purpose of a well-intentioned AP initiative. We provide an internally consistent and implementable solution to the problem through a comprehensive analysis of the myriad complicating factors and …