Review of the Food and Drug Administration's Citizen Petition Process

EXECUTIVE SUMMARY:

This final audit report points out that the Food and Drug Administration (FDA) does not have an effective process for handling citizen petitions in a timely manner, as evidenced by a backlog of about 250 petitions that have not been fully answered, some dating to the 1970's and early 1980's. Regulations require responses to citizen petitions within 180 days. The backlog of pending petitions includes issues that the petitioners believe are matters of public safety, and some have requested FDA to ban or withdraw approval of certain products. In situations where the FDA does not answer petitions in a timely manner, the public may lose confidence in the regulatory process. Because the citizen petition process is not a high priority at FDA, the agency has provided limited resources to the process, and there is little central oversight of the process across FDA program areas. The FDA generally concurred with our recommendations on actions FDA should take to reduce the backlog and more effectively manage the process for responding to citizen petitions.

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