Citizens Petition 1
A public filing requesting FDA review of research questions concerning whether opioid exposure may be associated with measurable biological markers.
Administration
Petition Summary
What this petition says in plain language
Poses a research question
before the FDA
Formally requests FDA review of whether opioid exposure may be associated with measurable biological markers.
Summarizes why the question merits review
Explains the public health importance and the need for further investigation based on existing evidence.
Draws on published and archival sources
Cites peer-reviewed research, government reports, and other relevant materials to support the request.
Asks for review and consideration
Requests that the FDA consider the evidence and determine whether additional research or guidance are appropriate.
View the Petition
Evidence cited in this petition
Sun, E. C. et al. (2017).
Association of prescription opioid use with adverse health outcomes: a systematic review. AMA, 118(9), 1564–1571.
Zhou, Z. et al. (2020).
Opioid exposure and epigenetic modifications: a systematic review. Neuroscience & Biobehavioral Reviews, 118, 182–197.
Takahashi, M. et al. (2019).
DNA methylation changes in individuals with opioid use disorder, Translational Psychiatry, 9, 129.
U.S. Food and Drug Administration. (2022).
Opioids: Regulatory history and future considerations. FDA Drug Safety Communication.
Volkow, N. D. (2021).
The lasting biological effects of opioids: A call for further research. Nature Medicine, 27, 523–525.
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