October 16, 2018

FDA's Revised Draft Guidance on Citizen Petition Process Highlights Antitrust Risk for Filers


On October 2, 2018, the Food & Drug Administration released revised draft guidance titled Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).1 The revised draft guidance (Guidance) is an attempt to improve the efficiency of the FDA's citizen petition review, primarily expanding on the FDA's prior implementation and interpretation of a statutory provision aimed at preventing the alleged misuse of the citizen petition process to delay generic/biosimilar competition. FDA Commissioner Dr. Scott Gottlieb issued a statement indicating that the Guidance is intended to address concerns that some branded drug or reference biologic product manufacturers "'game' the system and take advantage of certain rules, or exploit loopholes, to delay generic approval—thereby extending a drug's monopoly beyond what Congress intended."2 Specifically, the Guidance (i) describes the circumstances under which the FDA may find that a citizen petition has been filed with the primary purpose of delaying FDA approval of a pharmaceutical or biosimilar and (ii) indicates that in those circumstances the FDA will reject the petition and refer the matter to the US Federal Trade Commission.

The Guidance is consistent with the Administration's recent emphasis on enhancing prescription drug competition. In February, the Department of Health & Human Services (HHS) issued its Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs,3 which advocates against manufacturers "gaming" regulatory processes to block or delay competitive entry. Antitrust enforcers have also been focused on the potential anticompetitive use of citizen petitions. On February 7, 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.4

These agency actions reflect the potential that petitioners may face increased scrutiny in situations where their petitioning may have competitive implications.

Background on Citizen Petition Process and Guidance

A citizen petition may be submitted to the FDA by any person requesting that the FDA either (i) issue, amend, or revoke a regulation or order or (ii) take or refrain from taking an administrative action (including refraining from approving a generic drug or biosimilar application).5 Section 505(q) of the FD&C Act provides that a citizen petition may not delay the approval of a generic drug unless such delay is necessary to protect the public health. To that end, the Guidance indicates that, if a petition is received while a generic drug application is under review and the FDA's goal date for a decision on that application falls within 150 days, the FDA will respond to the petition within 150 days.

Section 505(q) of the FD&C Act also requires the FDA to deny the citizen petition at any point if it "determines that a petition or a supplement to the petition was submitted with the primary purpose of delaying the approval of [a generic or biosimilar drug] application and the petition does not on its face raise valid scientific or regulatory issues[.]"6 The FDA has now revised the draft guidance to describe the factors considered in assessing whether a petition's primary purpose is to delay the approval of a generic or biosimilar drug application.

FDA Guidance

The FDA Guidance indicates that the following nonexclusive list of factors will be considered when assessing a citizen petition under Section 505(q):7

  • Timing
    • The petitioner waits an unreasonable length of time to submit the petition after the petitioner knew or reasonably should have known relevant information relied upon in the petition.
    • The petitioner submits a petition close in time to a known, first date upon which a generic drug or biosimilar application could be approved.
  • Number of Petitions
    • The petition raises issues that the petitioner reasonably could have known at the time of submission of earlier petition(s).
    • The petitions raise the same or substantially similar issues as a prior petition to which the FDA has already substantively responded, in particular when the subsequent submission follows the FDA's response closely in time.
  • Evidence
    • The petitioner submits "a petition without any data or information in support of its scientific positions."8
  • Forum
    • The petition concerns a drug product for which the FDA has provided an opportunity for public input, but the petitioner has not utilized that forum and instead relies only on the petition.
  • Consistency
    • The petition requests that other applicants must meet standards for testing, data or labeling that are more onerous or rigorous than the standards applicable to the applicable listed drug and/or petitioner's version of the same product.
  • Prior Petitions
    • The petitioner has a history of submitting petitions that the FDA has determined were submitted with the primary purpose of delay.

If the FDA determines 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.9


Government petitioning (such as submitting a citizen petition to the FDA) is typically considered protected First Amendment activity, and is thus immunized from antitrust challenge under what is known as the Noerr-Pennington doctrine.10 However, this protection does not apply to instances of "sham petitioning," where a petitioner is attempting to use the process itself to achieve a competitive advantage, as opposed to trying to obtain a competitive advantage by successfully petitioning.11 The sham exception applies only when the petitioning at issue is both "objectively baseless," in that no reasonable petitioner could realistically expect success on the merits, and motivated by a subjective desire to use the process to interfere directly with the business relationships of a competitor.12

An FDA finding that a citizen petition was filed with the primary purpose of delaying a generic drug or biosimilar application would be evidence probative of both the objective and subjective prongs of the sham exception. This in turn would increase the risk that a petitioner, if sued, would lose the First Amendment protections normally provided under the Noerr-Pennington doctrine.

In addition, the FDA's decision to publicize its findings and refer such matters to the FTC increases the risk of both government enforcement and private litigation.

In light of the revised draft Guidance, the FTC's demonstrated interest in pursuing potential misuse of citizen petitions, and the broader governmental interest in pharmaceutical competition and pricing, petitioners should provide a strong and timely substantive basis for any citizen petition and assess carefully the potential antitrust risks associated with such filings.

© 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. 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).

  2. "Statement from FDA Commissioner Scott Gottlieb, MD, on new agency actions to further deter 'gaming' of the generic drug approval process by the use of citizen petitions" (Oct. 2, 2018). Dr. Gottlieb also noted in the statement that "citizen petitions have rarely delayed specific generic drug approvals."

  3. 83 Fed. Reg. 22,692 (May 16, 2018).

  4. Complaint, FTC v. Shire ViroPharma Inc., No. 1:17-cv-00131 (D. Del. Feb. 7, 2017). The FTC's lawsuit, seeking a permanent injunction and other equitable relief, alleged that Shire ViroPharma violated Section 5 of the FTC Act by engaging in unfair methods of competition. Specifically, the FTC charged that Shire ViroPharma made 46 filings from March 2006 to April 2012 (including Citizen Petitions, public comments, a Supplemental New Drug Application, and lawsuits) to obstruct and delay the FDA approval process for a generic version of Vancocin. On March 20, 2018, the District Court dismissed the FTC's complaint based on a finding that the FTC did not have the statutory authority to seek a permanent injunction in a case where it did not allege Shire ViroPharma was violating or was about to violate a law enforced by the FTC. FTC v. Shire ViroPharma Inc., No. 1:17-cv-00131, 2018 WL 1401329, *1, *6 (D. Del. Mar. 20, 2018). Although Shire ViroPharma argued that its conduct was protected by the First Amendment under the Noerr-Pennington doctrine (discussed below), the District Court declined to dismiss the FTC's complaint on those grounds. Id. at *7. On April 11, 2018, the FTC appealed the District Court's decision to the Third Circuit. 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. 21 USC § 355(q)(1)(E).

  7. Guidance at 15-16.

  8. Id. at 16.

  9. Id. at 16-17.

  10. See United Mine Workers v. Pennington, 381 US 657 (1965); Eastern R.R. Presidents Conference v. Noerr Motor Freight, 365 US 127 (1961).

  11. Noerr, 365 US at 144.

  12. See Prof'l Real Estate Investors v. Columbia Pictures Indus., 508 US 49, 60-63, 67 (1993).

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