FDA Citizen Petition Process

Abstract

The US Food and Drug Administration (FDA) is a federal agency that has authority to regulate a variety of drugs, biologics, foods, cosmetics, and devices. During the course of regulatory review, the FDA provides the public with opportunities to ‘‘weigh in’’ regarding the process. One such avenue is via the citizen petition process. Under FDA regulations, any individual, group, or company can submit a citizen petition to the agency requesting the FDA Commissioner to ‘‘issue, amend, or revoke a regulation/order OR take or refrain from taking any other form of administrative action.’’ This process has long been used for a variety of purposes such as demanding a response from the FDA regarding drug importation or requesting a ban on the use of latex gloves in health care settings. Recently, there has been some controversy surrounding citizen petitions as brand name pharmaceutical manufacturers have been accused of misusing the process in order to delay or prevent the timely approval of generic competitors. In addition, there has been concern regarding health care organizations and individuals with financial ties to manufacturers submitting letters of support for certain citizen petitions. For example, in February 2003, sanofiaventis submitted a citizen petition to the FDA arguing against the approval of generic versions of enoxaparin (Lovenox). During the time period when the FDA was developing a response to the petition, the North American Thrombosis Forum, the Society of Hospital Medicine, and a Duke University medical researcher all wrote letters to the FDA arguing that generic versions of enoxaparin may not be as safe as brand name Lovenox, essentially supporting the citizen petition filed by sanofi-aventis. None of these organizations or individuals mentioned their existing financial relationships with sanofi-aventis in their letters to the FDA. The citizen petition process is initiated with submission of the petition to the Dockets Management Branch of the FDA. The petition is then dated, assigned a docket number, referred to the appropriate FDA center, such as the Center for Drug Evaluation and Research (CDER), and posted on a Web site (www.regulations.gov) for open comment. Filing a petition immediately triggers more review by the FDA regarding the issue(s) at hand. Historically, the filing of a citizen petition regarding a generic drug approval could add months to years to the time period required to receive marketing approval. The majority of such filings are ultimately rejected by the FDA. According to a Washington Post article, 20 of 21 citizen petitions filed by brand name manufacturers from 2003 to July 2006 were ultimately denied by the FDA. In June 2011, the FDA published a guidance document for industry containing nonbinding recommendations on the process entitled ‘‘Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act.’’ This document provides a description of the FDA interpretation of subsection 505(q) of the Food, Drug, and Cosmetic Act as related to citizen petitions. This subsection states that the FDA may not delay the approval of a pending abbreviated new drug application (ANDA) or 505(b)(2) application (ie, a medication that contains the same active ingredient as a previously approved product, but now has a different delivery mechanism or indication) unless a formal determination that ‘‘a delay is necessary to protect the public health’’ is made based upon the information within the citizen petition. Within 30 days of making the determination, the FDA must notify the ANDA/ 505(b)(2) applicant of the decision, provide clarification or additional data that the applicant must submit if applicable to allow for further review of the petition, and summarize the specific substantive issues within the citizen petition that form the basis for the delay determination. The subsection also allows for the FDA to deny a citizen petition at any time that was ‘‘submitted with the primary purpose of delaying the approval of an application’’ and ‘‘does not on its face raise valid scientific or regulatory issues.’’ The FDA must take final action on the petition no later