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Article
The Drug Shortage Crisis: What Happens When Generic Manufacturers "Just Say No"
Oregon Law Review (2014)
  • Stacey B. Lee, Johns Hopkins University Carey Business School
Abstract
In the past five years, the number of drug shortages in the United States has nearly quintupled. The majority of shortages involve generic sterile injectables used to fight infectious diseases and treat cancer. These complex drugs are produced in a concentrated market consisting of only a few generic manufacturers. Any disruption in their supply can result in shortages that leave patients without access to life-saving drugs which in some cases are the only treatment for their condition. These chronic shortages have been linked to many possible factors including product quality concerns, discontinuation of product lines, changes in supply and demand, and manufacturing problems. Recent federal legislation attempts to address the drug shortage problem by focusing on generic manufacturers’ notification responsibilities. Specifically, the FDA is now authorized to require sole manufacturers of life-saving and life-supporting drugs to alert the agency of impending shortages. While this requirement may alleviate some of the factors associated with the supply problems of critical drugs, this approach fails to address the underlying causes.
Despite reoccurring drug shortages, generic manufacturers have not increased production of these life-saving medicines. This Article explores the confluence of regulatory constraints and market failures behind the shortages. In doing so, this Article posits that drug shortages will continue until generic manufacturers have the financial incentives and production capacity to respond to increased demand. This Article offers a multi-pronged approach on the regulatory, legislative, and private sector fronts that would allow generic manufacturers to profitably maintain production levels sufficient to meet patient demand.
Keywords
  • drug shortage,
  • generic manufacturers
Publication Date
March 15, 2014
Citation Information
Stacey B. Lee. "The Drug Shortage Crisis: What Happens When Generic Manufacturers "Just Say No"" Oregon Law Review Vol. 42 (2014)
Available at: http://works.bepress.com/stacey_lee/11/