The Antitrust Implications of Filing 'Sham' Citizen Petitions with the FDA

40 Pages Posted: 27 Oct 2015

See all articles by Matthew Avery

Matthew Avery

Baker Botts LLP

William J Newsom

Cooley LLP

Brian Hahn

Gazdzinski & Associates, P.C.; UC Law, San Francisco

Date Written: December 2013

Abstract

The First Amendment protects the right of all citizens to petition the government. The Food and Drug Administration (the "FDA") has provided a means by which citizens or interested entities can voice their concerns to the FDA by filing a so-called "citizen petition." However, some brand-name pharmaceutical companies have abused this process by filing baseless petitions with the FDA in an effort to delay generic competition. Such anticompetitive activity is generally protected by the Noerr-Pennington doctrine, which grants antitrust immunity to activity that involves petitioning the government for redress. However, the immunity does not apply to "sham" petitions, the main objective of which is to cause anticompetitive harm through the process, rather than the outcome, of a petition. The citizen petition process has provided a number of examples of likely sham petitions, resulting in delayed generic entry into the market. In some cases, such delay has resulted in billions of dollars in extra profits for brand-name manufacturers submitting "sham" petitions, at the expense of consumers and generic manufacturers.

This Article analyzes recent cases in which plaintiffs allege that the citizen petitions aim to delay generic entry, and suggests precautions that practitioners can take in such lawsuits. It proposes a variety of changes to FDA regulations, as well as additions to judicial doctrines, to curb the problems caused by sham petitions. It also serves as a guide to brand-name manufacturers who wish to avoid liability under the "sham" exception. These proposals may become more relevant as the rate of filing citizen petitions grows and more generic drug applications accrue in the FDA’s backlog.

Keywords: antitrust, FDA, citizen petitions

JEL Classification: K21, K23, K42

Suggested Citation

Avery, Matthew and Newsom, William J and Hahn, Brian, The Antitrust Implications of Filing 'Sham' Citizen Petitions with the FDA (December 2013). Hastings Law Journal, Vol. 65, No. 1, 2013, Available at SSRN: https://ssrn.com/abstract=2680260

Matthew Avery (Contact Author)

Baker Botts LLP ( email )

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William J Newsom

Cooley LLP ( email )

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Brian Hahn

Gazdzinski & Associates, P.C. ( email )

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San Diego, CA 92127
United States
(858) 675-1670 (Phone)

UC Law, San Francisco ( email )

200 McAllister Street
San Francisco, CA 94102
United States

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