FDA Citizen Petitions: A New Means of Delaying Generic Entry?

Antitrust Health Care Chronicle, Vol. 20, No. 3, p. 10, 2006

4 Pages Posted: 6 Jan 2010

Date Written: Fall 2006

Abstract

Food and Drug Administration (FDA) citizen petitions have received attention as a possible means of inhibiting generic pharmaceutical competition. Citizen petitions are submissions designed to alert the FDA to possible scientific and safety issues related to regulated products or agency procedures. Generic pharmaceutical companies have alleged that branded pharmaceutical companies have improperly used citizen petitions to block or delay entry of generic competitors by raising frivolous or untimely concerns about generic companies’ Abbreviated New Drug Applications (ANDA).

Yet to date, there is little evidence that citizen petitions by branded pharmaceutical companies have injured competition by delaying generic entry. As a result, Federal Trade Commission (FTC) appears to have little interest in investigating or challenging these filings. Private actions to challenge this practice are likely to face significant challenges overcoming Noerr immunity and establishing antitrust injury.

Keywords: Antitrust, Citizen Petition, FDA, ANDA

JEL Classification: I18, K21, K23, L40, L41, L43

Suggested Citation

Tucker, Darren S., FDA Citizen Petitions: A New Means of Delaying Generic Entry? (Fall 2006). Antitrust Health Care Chronicle, Vol. 20, No. 3, p. 10, 2006. Available at SSRN: https://ssrn.com/abstract=1531776

Darren S. Tucker (Contact Author)

Vinson & Elkins LLP ( email )

2200 Pennsylvania Ave NW
Washington, DC 20037
United States

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