FDA Issues Final Guidance on Citizen Petitions and Stay of Action Petitions Subject to FDCA Section 505(q)

Wilson Sonsini Goodrich & Rosati

Introduction: Citizen Petitions in the News

Citizen petitions and stay of action petitions (collectively, citizen petitions or petitions) are in the news. Formally, citizen petitions are a mechanism for "interested persons" to initiate certain types of "administrative proceedings" at the U.S. Food and Drug Administration (FDA). A citizen petition can be used to ask the Commissioner of the FDA to:

  1. Issue, amend, or revoke a regulation or order; or
  2. Take or refrain from taking any other form of administrative action.

Initiating administrative proceedings, for example, is at first glance not eye-catching. So why are citizen petitions in the news? There are several reasons.

Differential Impacts of Citizen Petitions

Alert the FDA, and the public, to health hazards

In some instances, citizen petitions, which are published after being filed, can alert the public to a health hazard. An example is Valisure's citizen petition, filed in September of this year, alerting the FDA (and the public) to the presence of high levels of N-Nitrosodimethylamine, a probable carcinogen, in the drug ranitidine—commonly sold under the brand Zantac.

Disadvantage a competitor

In other instances, citizen petitions, in addition to raising potential issue(s) of safety or efficacy, can concurrently disadvantage a competitor. See, for example, dietary supplement ingredient supplier ChromaDex's first citizen petition and supplemental citizen petition requesting e.g., that the FDA "investigate and take appropriate remedial action" against Elysium Health Inc., which markets the dietary supplement Basis.

These petitions prompted litigation between the parties where, among other things, Elysium complained that ChromaDex was seeking to sabotage Elysium's business; and ChromDex moved to dismiss the complaint as being barred under the Noerr-Pennington Doctrine. The Noerr-Pennington Doctrine, arising from two U.S. Supreme Court cases, holds generally that companies can be immune from liability under the antitrust laws for attempts to influence, for example, the enforcement of laws—even if the laws they advocate for would have anticompetitive effects—because this immunity protects a company's right to petition the government. Noerr-Pennington immunity is not absolute, and may not apply if the petition is found to be a "sham" petition. We previously wrote about ChromaDex's first citizen petition in the broader context of the FDA's regulation of dietary supplements.

Delay or stop approval of a generic drug, licensing of a biosimilar, or approval of a repurposed drug

Additionally, citizen petitions can be and have been used to attempt to directly or indirectly delay or stop approval of a generic drug or repurposed drug or license of a biosimilar—that is, to attempt to delay or derail: the FDA's approval of an abbreviated new drug application, or ANDA; of licensing of a 351(k) or biosimilar application; or approval of a repurposed drug application, or 505(b)(2) application.

Citizen Petitions as Lifecycle Management Tools

According to one study, citizen petitions filed by branded drug companies (505(q) citizen petitions, as described below), in almost every case (92 percent of the time) are targeted to delaying generic drug market entry, or keeping generic drugs off of the market. Robin Feldman, Arthur J. Goldberg Distinguished Professor of Law and Director of the Center for Innovation at the University of California, Hastings, College of Law, has written extensively about tactics pharmaceutical companies employ to extend market exclusivity. Feldman has been quoted as stating, regarding citizen petitions, that the "FDA's number one job is safety. That's what they are good at. They're not designed as a competition policing agency."

Against the backdrop of pharmaceutical companies trying to extend drug franchise exclusivity, the White House and the FDA have been trying to lower drug prices. We recently discussed how the Executive Branch is attempting to lower drug prices, and steps the FDA is taking to facilitate bringing generic drugs to market, including competitive generic therapies, or CGTs. Now, the FDA has issued a final guidance (the final guidance) to address e.g., stay of action petitions and some citizen petitions. Below we discuss some key provisions of the FDA's final guidance.

The FDA's Final Guidance

Section 505(q) of the Federal Food, Drug, and Cosmetic Act (FDCA) governs "certain citizen petitions and petitions for stay of Agency action that request that FDA take any form of action related to a pending" generic drug, or ANDA application; repurposed drug application; or a biosimilar application (a 351(k) application). Section 505(q)(1)(A) of the FDCA recites in part that:

The Secretary shall not delay approval of a pending application… because of any request to take any form of action relating to the application… unless the Secretary determines, upon reviewing the petition, that a delay is necessary to protect the public health.

Thus, the FDA shall not delay approval of an ANDA, biosimilar, or repurposed drug application because of a petition unless the agency determines that the delay is necessary to protect the public health.

How the FDA determines if Section 505(q)(1)(A) applies to a petition

Key takeaways from the final guidance expand upon how the FDA determines if Section 505(q)(1)(A) applies to a petition. The analysis employed by the FDA is a multistage analysis, and at each stage, the FDA can determine that Section 505(q)(1)(A) does not apply to a petition.

Stage 1: Does the petition meet five initial gating criteria?

The first step in the analysis is a requirement that the petition meet all of the following criteria:

  1. the petition is submitted to the FDA on or after September 27, 2007 (for a petition relating to an ANDA or 505(b)(2) application); or on or after July 9, 2012 (for a petition relating to a biosimilar application);
  2. the petition must have been submitted in writing;
  3. the application that is the subject matter of the petition is pending at the time the petition is submitted to the FDA, and the application's user fee goal date is on or before the 150-day deadline for final agency action on the petition;
  4. the petitioner requests an action that could delay approval of a pending application; and
  5. the petition does not fall within any section 505(q)(4) exception (e.g., the petition is from the applicant of the ANDA, biosimilar, or repurposed drug application and seeks to only have the FDA take or refrain from taking any action with respect to that application).

If the petition passes the stage 1 analysis, the FDA next determines, in stage 2, if the petition can be summarily denied.

Stage 2: Can the petition, even if it meets the five stage 1 initial gating criteria, nevertheless be summarily denied?

If the petition meets all of the above requirements, then the FDA next determines if the petition may be summarily denied. FDCA Section 505(q)(1)(E) recites in part that:

If the Secretary determines that a petition or a supplement to the petition was submitted with the primary purpose of delaying the approval of an application and the petition does not on its face raise valid scientific or regulatory issues, the Secretary may deny the petition at any point based on such determination.

Petitions that the agency determines on their face do not raise valid scientific or regulatory issues, and have been submitted with the primary purpose of delaying application approval, will be summarily denied by the FDA. If a petition cannot be summarily denied, the FDA next applies a but for test to determine if the petition would be the cause of an application delay to again try to exclude the petition.

Stage 3: If the first two stages do not screen out the petition, does the petition meet the "but for" test?

If the ANDA, biosimilar, or repurposed drug application would not be ready for approval or license within the 150-day period for final Agency action on the petition, section 505(q)(a)(1) would not be implicated. Alternatively, if the ANDA, biosimilar, or repurposed drug application would be ready for approval or license within the 150-day period for final agency action on the petition but for resolution of the issues raised in the petition, then the FDA would next determine if a delay of approval is necessary to protect the public health.

Stage 4: If the petition meets the "but for" test, is delay of approval necessary to protect the public health?

Assuming the petition passes the first three stages of analysis, the agency must then determine if the delay in approval is necessary to protect the public health. The FDA considers the following scenario:

If the application were to be approved before the Agency completed the substantive review of the issues in the petition and, after further review, the Agency concluded that the petitioner's arguments against approval were meritorious, could the presence on the market of drug products that did not meet the requirements for approval identified by the petitioner negatively affect the public health?

If the FDA concludes the public health could be negatively affected, the FDA will conclude that a delay is necessary.


Citizen petitions are in the news because of the impacts successful petitions can have on competitors and the public health. As described above, a citizen petition arguing for delaying approval of a repurposed drug, ANDA, or biosimilar application under Section 505(q) will only be effective if it meets all of the FDA's gating criteria. This will require careful planning and good legal counsel when crafting the citizen petition.

Similarly, when a delaying citizen petition is lodged against a drug application at the FDA, the company sponsoring the drug application should carefully consider the FDA's gating criteria when weighing the probability of petition success, and when rebutting the petition or responding to questions proffered by the FDA.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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