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Agnes Shanley is senior editor of BioPharm International.
The agency seeks comments on a draft guidance designed to make the process conform to its original intent as a communication tool, rather than a roadblock to competition and innovation.
In news that should be welcome to biosimilars and generic pharmaceutical developers, FDA is planning to update its citizen’s petition process, and has asked for industry comments. The process was designed to facilitate the public’s ability to communicate issues of concern directly with FDA. Over the years, however, the process has been misused, as a way to block competition and innovation, rather than communicate important information to regulators. Research has found that, between 2011 and 2015, name-brand pharmaceutical companies filed 92% of all the 505(q) citizen’s petitions sent to FDA, and FDA approved only 8% of them. (1)
Before he left the agency, former FDA Commissioner Scott Gottlieb noted that the petition process had become a way of gaming the drug approval process and delaying generic competitors from entering the market. In an official press statement (2) issued on Oct. 2, 2018, Gottlieb said that the agency would be revising guidance on citizen’s petitions. “While the record shows that citizen petitions have rarely delayed specific generic drug approvals, there’s no doubt that the process requirements associated with 505(q) petitions can add to resource burdens on the generic drug review process and the FDA’s regulatory decision making. This increased burden on the FDA can take resources away from the daily work of application review,” he said. He noted that, in the future, FDA intends to refer petitions that seek to block new market entries directly to the United States Federal Trade Commission. “We hope that this increased transparency will reduce gratuitous hurdles to generic drug development and approval,” he said, noting that the Agency would include a response to any petitions received within the 150-day application-review timeline that the agency has set as a new goal.
On Sept.19, 2019, FDA released a revised draft guidance for public comment (3), publishing it in the Federal Register (4). The agency’s goal was to describe factors that FDA will consider in determining whether the petition is serious or whether its primary purpose is to delay a competitor’s application (3). “With this guidance, the Agency is addressing ‘gaming’ by brand-name drug companies that may try to delay generic and biosimilar drug approvals, including discouraging petitions submitted with the primary purpose of delaying approval of applications, said FDA spokesman Charlie Kohler.
The guidance lays out factors that FDA will consider in determining whether a petition is submitted with the primary purpose of delaying the approval of an application, Kohler explains. If the Agency determines that a petitioner has submitted a petition to delay the approval of an application, he says, FDA may note this determination in the petition response, which will be available to the public through the citizen petition docket. The guidance states that FDA also intends to refer these matters to the Federal Trade Commission, and to highlight these determinations in its annual report to Congress, he says.
The guidance also explains that FDA intends to treat petitions as being subject to the 150-day timeline established under section 505(q). This will apply only if the abbreviated new drug application (ANDA), 505(b)(2) new drug application (NDA), or 351(k) application targeted by the petition is pending when the agency receives the petition and the pending application has a user-fee goal date on or before the 150-day timeframe for final agency action on the petition, Kohler explains. This policy aligns the timeline to review and respond to petitions with the timeline for review of the applications themselves, consistent with user fee goal dates. This approach ensures that scientific and regulatory issues raised in a petition are considered prior to ANDA, 505(b)(2) NDA, or 351(k) approval, he says.
The petition process made headlines during the past few months when the online pharmacy Valisure petitioned FDA to alert regulators to the fact that testing had revealed presence of nitrosamine and other contaminants greatly in excess of established safe limits. LINK TO NEWS STORY ON RANITIDINE
“Citizens petitions offer a powerful way to gain attention for serious problems,” said Valisure CEO David Light.
Kohler explained that the petition process allows any “interested person” to petition FDA to issue, amend, or revoke a regulation or order, or to take or refrain from taking any other form of administrative action, as specified by 21 CFR 10.25(a). Thus, citizen petitions can be submitted on safety and/or quality issues, he said.
As an alternative to the citizen’s petition, in order to report quality issues, manufacturers would typically have to contact FDA’s Office of Regulatory Affairs (ORA) directly and file a Field Alert Report (FAR) outlining the product, manufacturer, defect, lots impacted, expiry, and the firm’s investigation into the root cause of the defect, Kohler said. ORA field coordinator information can be found via the following link https://www.fda.gov/safety/industry-guidance-recalls/ora-recall-coordinators.
The FAR regulations were established to speed the identification of quality defects in distributed drug products that may present a potential safety threat. Under these regulations, new or abbreviated new drug application (NDA and ANDA) applicants must submit information about distributed drug products regulated by FDA’s Center for Drug Evaluation and Research (CDER) or by FDA’s Center for Biologics Evaluation and Research (CBER).
As Kohler explains, an NDA or ANDA applicant must submit a FAR to FDA within three working days of receiving the following:
Manufacturers may also provide such information to the agency by contacting the CDER Office of Communications, Division of Drug Information, Kohler said, or by contacting the CDER Office of Pharmaceutical Quality or the CDER Office of Compliance, Office of Manufacturing Quality.
If there is a consumer report of an adverse event or serious problem, FDA may be contacted at the following website: https://www.fda.gov/safety/reporting-serious-problems-fda/how-consumers-can-report-adverse-event-or-serious-problem-fda.
Between 2008 and 2015, Kohler said, CDER received 683 Citizen Petitions, of which 175 were subject to section 505(q). This represents approximately 26% of all citizen petitions received by CDER during this time period. More information can be found in HYPERLINK “Annual Reports to Congress on Delays in Approvals of Applications Related to Citizen Petitions and Petitions for Stay of Agency Action by Fiscal Year.”