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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."

SUBMITTER: Chen BK

PROVIDER: S-EPMC4865109 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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Petitioning the FDA to Improve Pharmaceutical, Device and Public Health Safety by Ordinary Citizens: A Descriptive Analysis.

Chen Brian K BK Yang Y Tony YT Cheng Xi X Bian John J Bennett Charles L CL

PloS one 20160512 5

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 wer ...[more]

PMID: 27171162

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Project description:BackgroundeConsulta-that is, asynchronous, two-way teleconsultation in primary care-is one of the most important telemedicine developments in the Catalan public health system, a service that has been heavily boosted by the onset of the COVID-19 pandemic. It is vital to know the characteristics of its users in order to be able to meet their needs and understand the coverage of this service in a context where there is reduced accessibility to the health system.ObjectiveThis study aims to analyze the profile of the citizens who use the eConsulta tool and the reasons for their use, as well as to gain an understanding of the elements that characterize their decision to use it while distinguishing between those who used it before and those who have used it since the onset of the COVID-19 pandemic.MethodsA descriptive, observational study based on administrative data was performed. This study differentiates between the COVID-19 pandemic era and the period preceding it, considering the day the state of emergency was declared in Spain (ie, March 12, 2020) as the cut-off point. It also differentiates between eConsulta users who send messages and those who only receive them.ResultsDuring the pandemic, the number of unique users of this teleconsultation service had almost tripled, with up to 33.10 visits per 1000 inhabitants per month reported in the first three months. For the two user profiles analyzed, most users since the start of the COVID-19 outbreak were predominantly female, systematically younger, more actively employed, and with less complex pathologies. Furthermore, eConsulta users received more messages proactively from the health professionals. There was also a relative decrease in the number of conversations initiated by higher-income urban users and an increase in conversations initiated by users in rural areas.ConclusionsThe COVID-19 pandemic has helped to generalize the use of telemedicine as a tool to compensate, to some extent, for the decline in face-to-face visits, especially among younger citizens in Catalonia. Telemedicine has made it possible to maintain contact between citizens and the health care system in the context of maximum complexity.

Dataset Information

Petitioning the FDA to Improve Pharmaceutical, Device and Public Health Safety by Ordinary Citizens: A Descriptive Analysis.

Publications

Petitioning the FDA to Improve Pharmaceutical, Device and Public Health Safety by Ordinary Citizens: A Descriptive Analysis.

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