Public health is everyone’s responsibility. The First Amendment of the U.S. Constitution allows citizens to petition the government for “a redress of grievances. This allows citizens to petition administrative agencies, such as the Food and Drug Administration (FDA), to take safety actions to advance public health.
In a new study, Tony Yang, associate professor in the Department of Health Administration and Policy, collaborated with Brian K. Chen and Xi Cheng of the University of South Carolina’s Arnold School of Public Health, and John Bian and Charles L. Bennett of the University of South Carolina’s South Carolina College of Pharmacy, to analyze citizen petitions to the FDA. The study is published in PLOS One.
The study examined 1,915 petitions submitted to the FDA between 2001 and 2013 and investigated the outcomes of petitions that addressed public health concerns. Eighteen percent (346) petitions were submitted by individuals and nonprofit organizations. Of those, 87.3% (178) were denied.
“Most petitions addressed risk communications, such as labeling changes, boxed warnings, or placement of a drug into a Risk Evaluation and Mitigation Strategy,” Yang said.
Most denials occurred because of failure to present sufficient and/or convincing evidence. The FDA can deny petitions for several additional reasons, including petitions that are legally and scientifically sound but have an unfavorable cost-benefit analysis.
“The FDA also prefers to grant only incremental requests rather than sweeping changes,” Yang said. “In addition, organizations and professionals with legal and scientific expertise are more likely to receive a positive response.”
On average, petitions take 2.85 years to receive a final decision; however, many decisions are pending for 10 to 13 years from the time of initial submission.
“Our analysis found that individual citizen petitions are not often successful, mostly because the petition does not provide enough data for the FDA to make a determination,” Yang said. “It takes an extensive review of peer-reviewed literature or randomized controlled trials to provide that level of evidence. Citizens may be see more positive outcomes if they partner with an organization that has regulatory experience.”