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December 7, 2018

FTC Comment on FDA's Guidance on Citizen Petition Process Underscores Antitrust Risk


On December 4, 2018, the US Federal Trade Commission released a comment responding to the Food and Drug Administration's October 2, 2018 revised draft guidance titled Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act (the FTC "Comment" and FDA "Guidance," respectively).1

In its Comment, which the FTC approved in a 5-0 vote, the FTC stated that it "shares the FDA's concerns about patient access to lower-cost generic drugs and biosimilars" and reaffirmed its "longstanding interest in sham petitioning and other abuses of government processes that may inhibit competition."2

The FTC's support of the FDA's Guidance is consistent with its recent antitrust litigation initiatives. In particular, in early 2017, the FTC challenged Shire ViroPharma Inc. for filing citizen petitions that the FTC alleges were used to maintain its monopoly in the sale of Vancocin® HCl Capsules.3 A decision dismissing the complaint on jurisdictional grounds is currently on appeal to the Third Circuit Court of Appeals.4

As a result of these recent agency actions, citizen petitions submitted by pharmaceutical companies are likely to face increased scrutiny by both the FDA and the FTC.


In the pharmaceutical context, citizen petitions are often submitted to request that the FDA refrain from approving a generic drug or biosimilar application due to various legal and/or scientific issues, such as a label carve-out or bioequivalence concern.5

Among other things, the FDA's October 2, 2018 Guidance provided a nonexclusive list of factors that it will consider when assessing such citizen petitions, which are detailed in our October 16, 2018 Advisory describing the FDA's Guidance.

If the FDA determines that a petitioner submitted a citizen petition with the primary purpose of delaying the approval of a generic drug or biosimilar application, it will deny the petition summarily and include that determination in its petition response. In addition, the FDA will refer the matter to the FTC and publicize the determination in its annual report submitted to Congress.6

The FTC Comment

In its recent Comment, the FTC underscored the significant time and resources the FDA spends in responding to citizen petitions, many of which, according to the FTC, are ultimately denied for lack of merit. The FTC expressed support for the FDA's Guidance and emphasized its shared concern about pharmaceutical companies' "abuse" of citizen petitions to delay generic or biosimilar entry.7 The FTC stated that it "stands ready" to work with the FDA on this issue.8


In light of the revised draft FDA Guidance, the FTC's Comment and the broader governmental interest in pharmaceutical competition and pricing, pharmaceutical companies considering submitting a citizen petition should carefully assess the potential antitrust risks before making such a filing.

© Arnold & Porter Kaye Scholer LLP 2018 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.

  1. Federal Trade Commission Comment on the Food and Drug Administration's Revised Draft Guidance on Citizen Petitions, (Dec. 2018) {hereinafter, "Comment"}.

  2. Comment at 2.

  3. Complaint, FTC v. Shire ViroPharma Inc., No. 1:17-cv-00131 (D. Del. Feb. 7, 2017).

  4. Decision on the motion to dismiss, FTC v. Shire ViroPharma Inc., No. 1:17-cv-00131, 2018 WL 1401329, *1, *6 (D. Del. Mar. 20, 2018). Notice of Appeal, FTC v. Shire ViroPharma Inc., No. 1:17-cv-00131 (D. Del. Apr. 11, 2018).

  5. 21 CFR 10.30. The person submitting the petition need not be a US citizen.

  6. US Dep't of Health and Human Servs., FDA, Ctr. for Drug Evaluation and Research, "Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry—DRAFT GUIDANCE" (Oct. 2018), at 16-17.

  7. Comment at 5.

  8. Id. at 6.