Abstract
The United States Constitution protects the right of citizens to petition the government for “a redress of grievances.” This right has important implications for citizens desiring to advance the public health by petitioning administrative agencies, such as the Food and Drug Administration, to take safety actions. We examined a total of 1,915 petitions filed between 2001 and 2013 to investigate the outcomes of citizen petitions that address public health concerns. We found that most petitions were filed by manufacturers against other manufacturers. Only 346 (18%) of all petitions were submitted by individuals and non-profit organizations, and 178 (87.3%) of these petitions with a final response were denied. On average, these petitions required 2.85 years for a final agency decision, and many decisions remain pending 10–13 years after their initial submission. The great majority of the approved requests included some form of risk communication, such as labeling changes, boxed warnings or placement of a drug into a Risk Evaluation and Mitigation Strategy. As a policy instrument to improve the safety of medical and food products, the citizen petition process requires sophisticated legal and scientific expertise, and may not represent a viable route for ordinary citizens to petition the FDA to “redress grievances.”
Highlights
Based on the First Amendment right of citizens to “petition the Government for a redress of grievances,” Title 21, Section 10.30 of the Code of Federal Regulations stipulates that citizens may request the Food and Drug Administration (FDA) to “issue, amend, or revoke a regulation or order or take or refrain from taking any other form of administrative action.”[1]. These petitions have the potential to protect the public’s health
Only approximately 12.7% of petitions result in a favorable outcome, that the majority of petitions are denied because petitioners fail to present sufficient and/ or convincing evidence, that the FDA sometimes denies petitions that are legally and scientifically sound due to unfavorable cost-benefit assessments, that the FDA prefers to grant only incremental requests rather than sweeping changes, and that organizations and professionals with legal and scientific expertise are more likely to receive a positive response from the FDA
We separated outcomes into four categories–(a) petition granted in its entirely, if the FDA granted all of the requests contained in the petition; (b) petition granted partially with a substantive outcome, if the FDA granted at least one request leading to a decision that can potentially and directly improve public health; (c) petition granted partially with no substantive outcome, if the FDA granted at least one request that in itself alone is unlikely to lead to any changes in public health measures, and (d) petition denied in full
Summary
Based on the First Amendment right of citizens to “petition the Government for a redress of grievances,” Title 21, Section 10.30 of the Code of Federal Regulations stipulates that citizens may request the Food and Drug Administration (FDA) to “issue, amend, or revoke a regulation or order or take or refrain from taking any other form of administrative action.”[1] These petitions have the potential to protect the public’s health. The citizen petition process has primarily been used by for-profit industries, often to deter competition. FDA Citizen Petitions role in study design, data collection and analysis, decision to publish, or preparation of the manuscript
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