Empirical Evidence of Drug Companies Using Citizen Petitions to Hold Off Competition

13 Pages Posted: 14 Feb 2018 Last revised: 4 Mar 2018

Robin Feldman

University of California Hastings College of the Law

John Gray

University of California Hastings College of the Law

Giora Ashkenazi

University of California Hastings College of the Law

Date Written: February 2, 2018

Abstract

The FDA’s citizen petition process was created in the 1970s as part of an effort to fashion more participatory regimes, in which ordinary citizens could access the administrative process. The theoretical underpinnings hypothesize that a participatory structure will prevent regulatory agencies from being captured by the very industries they were intended to police. Anecdotal evidence suggests, however, that the FDA’s citizen petition process may have taken a different turn. This empirical study explores whether pharmaceutical companies are systematically using citizen petitions to try to delay the approval of generic competitors. Delaying generic entry of a drug — even by a few months — can be worth hundreds of millions of dollars of additional revenue, a cost ultimately borne by consumers and government agencies in the form of high drug prices.

The study provides empirical evidence that the citizen petition process at the FDA has now become a key avenue for strategic behavior by pharmaceutical companies to delay entry of generic competition. It is a far cry from the “participatory citizen” notion that fueled the creation of such avenues at regulatory agencies. The article concludes by examining the nature of the problem and exploring the feasibility of three types of approaches to curb the behavior. These include: 1) a simple prohibition, if one were to conclude that most behavior in the category is likely to be inappropriate; 2) procedural blocks to ensure that the behavior cannot create sub-optimal results; or 3) punitive measures as a deterrent.

Suggested Citation

Feldman, Robin and Gray, John and Ashkenazi, Giora, Empirical Evidence of Drug Companies Using Citizen Petitions to Hold Off Competition (February 2, 2018). UC Hastings Research Paper No. 269. Available at SSRN: https://ssrn.com/abstract=3116986 or http://dx.doi.org/10.2139/ssrn.3116986

Robin Feldman (Contact Author)

University of California Hastings College of the Law ( email )

200 McAllister Street
San Francisco, CA 94102
United States

John Gray

University of California Hastings College of the Law

200 McAllister Street
San Francisco, CA 94102
United States

Giora Ashkenazi

University of California Hastings College of the Law

200 McAllister Street
San Francisco, CA 94102
United States

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