67 Food and Drug L.J. 1 (2012)
25 Pages Posted: 10 Feb 2012 Last revised: 18 May 2012
Date Written: February 8, 2012
Drug shortages are emerging as a major public health threat. Grave concern has been expressed by the medical community and government officials, and the crisis has been highlighted in recent media stories. Nevertheless, little has been written to date in the legal literature about the drug shortage crisis, and this timely article begins to fill this gap. It provides a thorough analysis of the origins and implications of the drug shortage problem and formulates a multi-layered approach to addressing it. The article argues that drug shortages result from a combination of market failures and regulatory constraints. It proposes a blend of legislative, regulatory, and private-sector interventions that should deter undesirable conduct on the part of manufacturers and provide appropriate incentives to combat the drug shortage phenomenon.
Keywords: drug shortage, FDA, public health, pharmaceutical manufacturing, supply and demand, treatment outcomes, health care costs, comparative effectiveness research, market failure, regulatory constraints, DEA quotas, tax and market incentives, failure-to-supply provisions, Medicare reimbursement
JEL Classification: K23, K32
Suggested Citation: Suggested Citation
Hoffman, Sharona, The Drugs Stop Here: A Public Health Framework to Address the Drug Shortage Crisis (February 8, 2012). 67 Food and Drug L.J. 1 (2012); Case Legal Studies Research Paper No. 2012-4. Available at SSRN: https://ssrn.com/abstract=2001660