The Antitrust Implications of Filing ‘Sham’ Citizen Petitions with the FDA

Posted by Social Science Research Network

The Antitrust Implications of Filing ‘Sham’ Citizen Petitions with the FDA Matthew Avery (Baker Botts LLP), William J Newsom (Cooley LLP) & Brian Hahn (University of California)

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.