FTC Staff Comments on FDA's Proposed Regulations to Improve Efficiency of Citizen Petition Process

For Your Information

Staff of the Federal Trade Commission's Bureau of Competition and Policy Planning office has submitted comments to the U.S. Food and Drug Administration (FDA) regarding its proposed rule aimed at improving the citizen petition mechanism as one way for persons to contact the FDA concerning matters within its jurisdiction. Citizen petitions often raise legitimate issues concerning matters before the FDA, and issues raised in citizen petitions have played useful roles in ensuring the safety of various drug products. The FTC staff comment cautioned, however, that regulatory processes can provide an opportunity for anticompetitive abuses, and offered suggestions the FDA may wish to consider to discourage such abuse.

The staff comment noted that, in an industry where entry is regulated, such as those regulated by the FDA (e.g., medical devices, pharmaceuticals, etc.), "to delay competition may be a lucrative strategy for an incumbent," through "improper petitioning." The FTC staff said that its own observation of the pharmaceutical industry shows that existing product holders have an incentive to block generic entrants and may do so by raising concerns about a potential generic entrant's drug application before the FDA. "A competitor may raise these concerns itself or have them raised by independent parties (either individuals or groups) by providing consideration to file a citizen petition raising the issues, so as to disguise the anticompetitive intent behind the petitioning. The effect of such a petition," the staff said, "could be to delay FDA approval of a rival drug application, even if the petition is not ultimately upheld."

The staff comment suggested that the FDA may wish to require that: 1) the petitioner reveal whether it has received, or will receive, consideration for filing the citizen petition and the identity of the party furnishing the consideration; and 2) the petitioner provide a list, to the best of the petitioner's knowledge, of the other citizen petitions that have been filed on the same underlying matter (i.e., the same underlying drug product). In addition, the FDA may wish to further amend the certification so that the petitioner certifies that it has not knowingly and willfully made any materially false, fictitious, or fraudulent statement or representation in the petition such that the petitioner would be subject to criminal penalties for doing so. "The possibility of criminal penalties for perjury may also increase the reliability of the information contained in the petition to allow the FDA to review and respond to the petition in an expeditious manner," according to the staff letter.

Finally, the comment suggested that the FDA may wish to consider instituting a system through which petitions that the FDA suspects are being used for improper competitive purposes are referred to the FTC to determine if the antitrust laws may have been violated. "For example, a case in which a series of petitions is filed by the same party that raise no new issues, or in which a competitor files petitions that are duplicative or meritless, could be referred to the FTC," the staff letter stated.

This comment represents the views of the Bureau of Competition and Policy Planning office of the Federal Trade Commission, and not necessarily the views of the Commission itself or any individual Commissioner. The Commission vote authorizing staff to file the comment was 5-0.

Copies of the comment to the FDA are available from the FTC's web site at http://www.ftc.gov and also from the FTC's Consumer Response Center, Room 130, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580; toll-free: 877-FTC-HELP (877-382-4357); TDD for the hearing impaired 1-866-653-4261. To find out the latest news as it is announced, call the FTC NewsPhone recording at 202-326-2710.

(FTC Matter No.: V000005)

Contact Information

Media Contact:
Howard Shapiro
Office of Public Affairs
202-326-2176
Staff Contact:
Michael Wroblewski
Bureau of Competition
202-326-2155