Risky Business: Should the FDA Pay Attention to Drug Prices?

7 Pages Posted: 28 Mar 2018 Last revised: 10 May 2018

David A. Hyman

Georgetown University Law Center

William E. Kovacic

George Washington University - Law School; King's College London – The Dickson Poon School of Law

Date Written: December 1, 2017

Abstract

The Food and Drug Administration currently does not monitor drug prices. As FDA leaders note, the agency’s responsibility is for drug safety and efficacy, and besides they do not want to become embroiled in drug pricing controversies. However, monitoring drug pricing can be useful beyond any sort of pricing policy. Prices are information, and changes in drug prices can inform the FDA of supply shortages (which may be due to backlogs in FDA approvals), poor government policies (such as the recent Unapproved Drugs Initiative, which resulted in price increases without much safety gain to the public), and mischief on the part of drug makers (such as manipulation of the approval process).

Keywords: Food and Drug Administration, FDA, drug prices, drug safety, FDA approvals, Unapproved Drugs Initiative

JEL Classification: I18,

Suggested Citation

Hyman, David A. and Kovacic, William E., Risky Business: Should the FDA Pay Attention to Drug Prices? (December 1, 2017). Regulation, Vol. 40, No. 4, Winter 2017-2018; King's College London Law School Research Paper No. 2018-09; GWU Law School Public Law Research Paper No. 2018-28; GWU Legal Studies Research Paper No. 2018-28. Available at SSRN: https://ssrn.com/abstract=3148117

David A. Hyman (Contact Author)

Georgetown University Law Center ( email )

600 New Jersey Avenue, NW
Washington, DC 20001
United States

William E. Kovacic

George Washington University - Law School ( email )

2000 H Street, N.W.
Washington, DC 20052
United States
202.994.8123 (Phone)

HOME PAGE: http://www.law.gwu.edu/faculty/profile.aspx?id=1731

King's College London – The Dickson Poon School of Law

Somerset House East Wing
Strand
London, WC2R 2LS
United Kingdom

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