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THE LATEST: FTC Submits Comment on FDA Guidance Aimed at Deterring Abuse of Citizen Petition Process

The Federal Trade Commission (FTC) submitted comments supporting the Food and Drug Administration’s (FDA) guidance for assessing whether a pharmaceutical company petitioner is misusing the citizen petition process to delay approval of a competing drug.

WHAT HAPPENED:

  • The FDA released revised draft guidance intended to discourage pharmaceutical companies from gaming the citizen petition process.

  • The FTC expressed approval of the considerations the FDA will use to determine whether a petition was submitted to delay or inhibit competition.

  • The considerations the FDA will use include:

    • The petition was submitted unreasonably long after the petitioner learned or knew about the relevant information;

    • The petitioner submitted multiple and/or serial petitions;

    • The petition was submitted close to the expiration date of a known patent or exclusivity;

    • The petition’s scientific positions were unsupported by data or information;

    • The petition was the same or substantially similar to a prior petition to which the FDA had already substantively responded;

    • The petitioner had not commented during other opportunities for input;

    • The petition requested a standard more onerous or rigorous than the standard applicable to the petitioner’s drug product; and

    • Other relevant considerations, including the petitioner’s history with the FDA.

WHAT THIS MEANS:

  • Each of the FTC commissioners testified during Senate confirmation hearings that scrutinizing health care and pharmaceutical companies would remain a top priority of the Commission.

  • The FTC’s support of the FDA guidance appears to be part of a broader agenda to actively pursue sham petitions and discourage attempted abuses that seek to use Noerr-Pennington immunity as a shield in an administrative setting.

    • In 2017, the FTC filed a lawsuit in federal court alleging that Shire ViroPharma Inc. (Shire) violated antitrust laws through repeated use of sham petitioning.

    • Though the district court dismissed the FTC’s complaint, the FTC has lodged an appeal and appears committed to reining in alleged abuses of the citizen petition process.

    • Going forward, citizen petitions are likely to face even more scrutiny. Under the revised draft guidance, once the FDA determines that a petition was submitted primarily to delay competition, it will refer that determination to the FTC. Potentially anticompetitive petitions will now face two rounds of review by federal regulators.

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About this Author

William Diaz, McDermott Will Emery Law firm, Antitrust and Competition Lawyer
Partner

William Diaz is a partner in the law firm of McDermott Will & Emery LLP and is based in the Orange County office. He is a member of the Firm’s Antitrust & Competition practice group. His antitrust practice is focused on mergers and acquisitions, complex litigation, government investigations, and counseling on pricing, distribution, and consumer protection issues. 

949-757-7129
Gregory E. Heltzer, Mergers and Acquisitions Lawyer, Antitrust Attorney, McDermott Will Emery, Law Firm
Partner

Gregory E. Heltzer is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm's Washington, D.C., office.  He focuses his practice on defending mergers and acquisitions before the Federal Trade Commission, Department of Justice, state antitrust authorities and foreign competition authorities.  In addition, his practice also includes complex antitrust litigation, government investigations and antitrust counseling (e.g., advising agricultural cooperatives on the requirements of the Capper Volstead Act).

Greg has experience in all three branches of government. Prior to joining the Firm, he served as a judicial law clerk for the Honorable John A. Terry of the DC Court of Appeals. Before entering law school, Greg worked for the US Environmental Protection Agency in the Energy Star Program. He also served as a legislative intern on the staff of the US Senate Committee on Environment and Public Works under the late Senator John Chafee (R-RI).

202-756-8178
Jonathan Ende, attorney
Attorney

Jonathan Ende focuses his practice on antitrust and competition, with particular strength in regulatory matters. He has a great deal of experience in internal investigations, and has a keen insight on the manufacturing and biomedical industries in particular.

202-756-8768