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# Markey Probes FDA in ‘Inappropriate’ Fentanyl Prescribing
- URL: https://www.fdaweb.com/markey-probes-fda-in-inappropriate-fentanyl-prescribing/
- Published: 2018-08-21T12:00:00.000Z
- Updated: 2026-09-15T00:27:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142166

Sen. **Edward Markey** (D-MA) says it’s possible that FDA ignored red flags that may have resulted in inappropriate prescribing of a certain class of immediate release fentanyl products. In a [statement](https://www.markey.senate.gov/news/press-releases/as-opioid-overdose-deaths-increase-senator-markey-queries-fda-about-inappropriate-fentanyl-prescribing?ref=fdaweb.com), he referenced an analysis of the FDA REMS (Risk Evaluation and Mitigation Strategies) for the class of fentanyl medications that found that 42% of the prescriptions may not have been prescribed appropriately. “Despite this information of dangerous off-label prescribing, FDA supported a pharmaceutical industry-proposed change that reversed steps to ensure these fentanyl products were only prescribed to opioid-tolerant patients,” he says.

“It is concerning that manufacturers of risky prescription opioids, who stand to financially benefit from the proliferation of their products, are left to self-police the implementation of the REMS,” Markey says in a letter to FDA commissioner **Scott Gottlieb** (link in the statement). “Given that 115 people die each day from an opioid overdose caused by prescription drugs, it is important that FDA use its full authority to ensure prescription opioids are prescribed as intended, and patients and providers are well aware of potential risks.”