The Food and Drug Administration requires a Risk Evaluation and Mitigation Strategy for opioid analgesic products to ensure benefits outweigh the risks of addiction, abuse, and misuse.

the verdict

SUPPORTED

the evidence backs this

Recorded sources

3 sources for · 0 against

Counts group repeated records of the same source within each side. They do not measure evidence strength or source independence.

Is it true that the Food and Drug Administration requires a Risk Evaluation and Mitigation Strategy for opioid analgesic products to ensure benefits outweigh the risks of addiction, abuse, and misuse?

Yes. The Food and Drug Administration implements Risk Evaluation and Mitigation Strategies (REMS) for opioid analgesics to help manage and minimize the risks of addiction, abuse, and misuse.

Verdict: SUPPORTED · 3 sources for, 0 against · Last checked 4 Oct 2026

The analysis

The claim is a specific, factual statement regarding FDA regulatory authority and practice concerning opioid analgesics. Multiple retrieved papers explicitly reference the FDA's Risk Evaluation and Mitigation Strategy (REMS) for opioid analgesics and its purpose in mitigating addiction, abuse, and misuse, fully supporting the claim.

Evidence for · 3

Changes in misuse and abuse of prescription opioids following implementation of Extended‐Release and Long‐Acting Opioid Analgesic Risk Evaluation and Mitigation Strategy

2017

This study evaluates the US Food and Drug Administration's Extended-Release and Long-Acting Opioid Analgesic Risk Evaluation and Mitigation Strategy (ER/LA REMS), confirming its implementation to reduce risks of misuse and abuse.

Get citation

Bartelson, B. B., Lait, M. C. L., Green, J. L., Cepeda, M. S., Coplan, P. M., Maziere, J., Wedin, G. P., & Dart, R. C. (2017). Changes in misuse and abuse of prescription opioids following implementation of Extended‐Release and Long‐Acting Opioid Analgesic Risk Evaluation and Mitigation Strategy. doi.org. https://doi.org/10.1002/pds.4257

See more details

More for · 2

A safe in-home disposal system with every opioid prescription? Food and Drug Administration is considering a potential new Risk Evaluation and Mitigation Strategy that could impact pharmacists.

2021

This commentary discusses how Public Law 115-271 provided the FDA the authority to mandate a Risk Evaluation and Mitigation Strategy (REMS) specifically for opioid analgesic medications.

Get citation

Stubbings, J., Crawford, S. Y., & Menighan, T. (2021). A safe in-home disposal system with every opioid prescription? Food and Drug Administration is considering a potential new Risk Evaluation and Mitigation Strategy that could impact pharmacists.. doi.org. https://doi.org/10.1016/j.japh.2021.11.009

Surveillance of Pharmaceutical Risk-Mitigation Behavior: Applying and Comparing Statistical Process Control Methods Using Real World Data.

2026

This paper evaluates post-marketing surveillance using tapentadol extended release, explicitly noting it as an opiate governed by an FDA Risk Evaluation and Mitigation Strategy.

Get citation

H, B., JD, R., NE, C., & EH, M. (2026). Surveillance of Pharmaceutical Risk-Mitigation Behavior: Applying and Comparing Statistical Process Control Methods Using Real World Data.. doi.org. https://doi.org/10.1002/lrh2.70098

What does the evidence say?

Receipt History

Anyone with this link can read the claim and its public receipt, including any personal information in that text. Open permanent receipt.

Check your own claim

Challenge the receipt

I have a source that contradicts this verdict I have a source that supports it No source: request a receipt review Requests are recorded for review. This does not start an automatic check or guarantee a response time.

See the evidence timeline

Citation formatting by citeproc-js (Frank Bennett) and the Citation Style Language project. Source and licenses.

This receipt is an automated verdict against our published method · not an opinion about any author or publication.
Terms · Privacy · How verdicts work