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Citizen Petition Preemption Of FDA Action Barred Under Proposed Rule

This article was originally published in The Tan Sheet

Executive Summary

Pending FDA actions cannot be the subject of a citizen petition submitted to the agency under a proposed rule published in the Nov. 30 Federal Register.

Pending FDA actions cannot be the subject of a citizen petition submitted to the agency under a proposed rule published in the Nov. 30 Federal Register.

"For citizen petitions concerning agency orders, the proposal would...limit citizen petitions to requests that FDA amend or revoke an order that FDA has issued," the document states.

"In other words, a citizen petition could not be used to request that FDA amend pending [agency] orders or issue future FDA orders. This change will enable FDA to focus its resources on addressing substantive issues or controversies," the notice says.

The proposed rule is part of an effort to reduce the number of citizen petitions the agency must address and increase the efficiency of the review process. Comments on the proposal are due by Feb. 28.

Regulations requiring an FDA decision within 180 days have led to a serious backlog. "As of April 1999, several hundred citizen petitions have been filed and remain pending," the document notes.

FDA has found in many cases citizen petitions are not the most appropriate or efficient way to communicate with the agency. Petitions must compete with other agency activities, the proposed rule states, while a phone call or meeting request "is usually an easier, faster and more efficient way to discuss the same issue with the agency."

FDA repeatedly maintains in the proposal that limiting the circumstances in which a citizen petition is a viable form of communication "does not reduce or curtail access to or discussions with the agency."

"The fact that the information may not have been submitted in a citizen petition does not make the information any less persuasive or mean that it will receive less attention from FDA," the proposed rule assures.

To avoid submission of "frivolous or unsupported petitions," FDA's proposed rule would "require the citizen petition to be based on more than unsupported claims, allegations, or general descriptions of positions or arguments."

The proposed changes also would allow FDA to keep petition denials brief under certain circumstances without the need for "exhaustive or comprehensive analyses and responses to requests." This would "give FDA the flexibility to act quickly on petitions where detailed responses are unnecessary," the notice says.

Examples of when a concise denial is appropriate include petitions that address topics outside FDA's legal scope or submissions that are similar or identical to an earlier administrative action and provide no additional information. This would prevent petitioners from submitting the same petition after receiving an unfavorable response, the agency explains.

The proposed changes also would direct FDA to take action other than a formal response on a petition. This could occur when a submission addresses an ongoing or future rulemaking or when a response can be delivered via correspondence or meeting.

Other amendments would allow FDA to contact a petitioner for clarification on a submission and consolidated multiple citizen petitions. In addition, a submission could be considered withdrawn if the petitioner no longer exists or cannot be found, or when the petitioner expressively states a response is not needed, the agency says.

In addition to the changes outlined in the proposed rule, FDA notes it "has taken, or is exploring, various administrative approaches to reduce its citizen petition backlog and improve its handling" of petitions.

"FDA also is considering options for improving managerial and oversight responsibility for citizen petitions to ensure the citizen petition process is efficient and effective," the agency states.

The proposed rule incorporates suggestions from an HHS Office of the Inspector General review of the citizen petition process (1 (Also see "FDA citizen petition tentative replies should indicate agency position, IG says." - Pink Sheet, 3 Aug, 1998.)). OIG estimated implementing its suggestions would reduce the number of petitions by over 30%. However, the agency also has estimated it will take an average of 14 hours to formulate a response, up from 12 hours.

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