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• The FDA released revised draft guidance intended to discourage pharmaceutical companies from gaming the citizen petition process.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 Under the revised draft guidance, once the FDA determines that a petition was submitted primarily to delay competition, it will refer that determination to the FTC.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