Washington (August 17, 2018) – With new federal data showing a continued increase in opioid overdose deaths from 42,000 in 2016 to a provisional estimate of 49,000 in 2017, Senator Edward J. Markey (D-Mass.) today expressed concern that the Food and Drug Administration (FDA) ignored red flags that may have resulted in inappropriate prescribing of a certain class of immediate-release fentanyl products, placing patients at risk of addiction and overdose. A recent New York Times story revealed that certain fentanyl products may have been prescribed to patients for whom the medication was not indicated. An analysis of the FDA’s Risk Evaluation and Mitigations Strategies (REMS) – a series of specific actions required by the FDA of a drug manufacturer that is intended to lessen the risks of the drug being sold – for this specific class of fentanyl medications indicated that 42 percent of these prescriptions may not have been prescribed appropriately. Despite this information of dangerous off-label prescribing, the FDA supported a pharmaceutical industry-proposed change that reversed steps to ensure these fentanyl products were only prescribed to opioid-tolerant patients.
“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,” writes Senator Markey in his letter to FDA Commissioner Scott Gottlieb. “Given that 115 people die each day from an opioid overdose, including an overdose caused by prescription drugs, it is important that the FDA use its full authority to ensure prescription opioids are prescribed as intended, and patients and providers are well aware of the potential risks.”

A copy of Senator Markey’s letter can be found HERE.

For year, experts have questioned the effectiveness of REMS and FDA’s consistent evaluation of whether the process works as intended to mitigate risk associated with certain drugs, particularly prescription opioids. News reporting quotes one FDA official as stating that more stringent oversight of the REMS program would be “extremely onerous”. In his letter, Senator Markey asks the FDA to provide more information on assessments of the REMS process, REMS training requirements, and any further actions to strengthen the REMS process, among other issues.

Senator Markey has called for action at the FDA on off-label fentanyl prescribing. Senator Markey has also previously queried the FDA on its REMS process, with a specific focus on OxyContin and prescription opioids.