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

By , and on December 11, 2018

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  • The FDA released revised draft guidance intended to discourage pharmaceutical companies from gaming the citizen petition process.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 Under the revised draft guidance, once the FDA determines that a petition was submitted primarily to delay competition, it will refer that determination to the FTC.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.
Jonathan EndeJonathan Ende
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. Read Jonathan Ende's full bio.  


Gregory E. HeltzerGregory E. Heltzer
Gregory (Greg) E. Heltzer focuses his practice on defending mergers and acquisitions before the US Federal Trade Commission, US Department of Justice, state antitrust authorities and foreign competition authorities. Greg has extensive experience in evaluating whether potential transactions will be cleared by antitrust enforcers and developing a viable path for clearance. In addition, he handles complex antitrust litigation, government investigations and antitrust counseling. Read Greg Heltzer's full bio.


Will DiazWill Diaz
William (Will) Díaz litigates and counsels clients on antitrust cases, obtains Federal Trade Commission (FTC) and Department of Justice clearance on mergers, and defends clients in government investigations. Will has significant experience in the interplay between the antitrust and intellectual property laws and the issues that crossover into both areas, including standard-setting activities, patent pools, fair, reasonable and non-discriminatory (FRAND) licensing issues and patent misuse. He also has handled numerous litigations and transactions in the biotech, pharmaceutical and medtech industries. Read William Díaz's full bio.

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