title: Petitioning the FDA to Improve Pharmaceutical, Device and Public Health Safety by Ordinary Citizens: A Descriptive Analysis.
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."
authors.affiliation: Department of Health Services Policy and Management, Arnold School of Public Health, the University of South Carolina, Columbia, South Carolina, United States of America.
authors.forename: Brian K
authors.identifier: 0000-0001-6384-1673
authors.initials: BK
authors.lastname: Chen
authors.affiliation: College of Health and Human Services, George Mason University, Fairfax, Virginia, United States of America.
authors.forename: Y Tony
authors.initials: YT
authors.lastname: Yang
authors.affiliation: Department of Health Services Policy and Management, Arnold School of Public Health, the University of South Carolina, Columbia, South Carolina, United States of America.
authors.forename: Xi
authors.initials: X
authors.lastname: Cheng
authors.affiliation: South Carolina Center of Economic Excellence for Medication Safety and Efficacy, South Carolina College of Pharmacy, the University of South Carolina, Columbia, South Carolina, United States of America.
authors.forename: John
authors.initials: J
authors.lastname: Bian
authors.affiliation: South Carolina Center of Economic Excellence for Medication Safety and Efficacy, South Carolina College of Pharmacy, the University of South Carolina, Columbia, South Carolina, United States of America.
authors.forename: Charles L
authors.initials: CL
authors.lastname: Bennett
mesh_terms: D003657:Decision Making; D004864:Equipment and Supplies / Q000592:standards*; D006801:Humans; D007878:Legislation as Topic; D004364:Pharmaceutical Preparations / Q000592:standards*; D011634:Public Health / Q000592:standards*; D012307:Risk Factors; D012449:Safety; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004364:Pharmaceutical Preparations