"U.S. Pharmaceutical Gray Markets: Why Do They Persist—and What to Do about Them?". (December 2016)

• Record Type: Journal Article
• Authors: Hemphill, Thomas A.
• Is Part Of: Business and society review. Volume 121:Number 4(2016)
• Page Start: 529
• Page End: 547
• Publication Date: 2016-12
• Subjects: Industries -- Social aspects -- United States -- Periodicals; Industries -- Social aspects -- Periodicals; International business enterprises -- Social aspects -- Periodicals; Responsabilité sociale; Déontologie; Morale des affaires; Entreprise; Entreprise multinationale; Aspect social; 658.408
• DOI: 10.1111/basr.12101
• Languages: English
• ISSNs: 0045-3609

Abstract

Abstract: This article illustrates how a traditional U.S. pharmaceutical industry supply chain operates, beginning with pharmaceutical compounds and ending at patient‐dispensing hospitals or pharmacies. Furthermore, to place the problem of U.S. drug shortages in historical perspective, a review of the annual volume of such shortages over the last decade is undertaken. Following this review of recent drug shortages is an analysis of the market forces and business decisions that drive the creation of a pharmaceutical gray market, its attendant "price gouging" and product integrity issues, and the alterations in the traditional pharmaceutical industry supply chain model. In response to persistent drug shortages, the U.S. Food and Drug Administration (FDA) has recently been empowered by the executive and legislative branches of the U.S. government to actively address this issue. To reflect these FDA challenges, a thorough review of these new agency charges and responsibilities is undertaken. Lastly, an analysis of the results of recent FDA public policy actions on mitigating drug shortages, as well as recommendations tor market‐based solutions to the gray market problem that pharmaceutical manufacturers, hospitals and pharmacies could institute as industry‐wide standards of business practice, are discussed in the conclusion.