The claims were made at the same time as the US Food and Drug Administration (FDA) convened an advisory committee to discuss the Risk Evaluation and Mitigation Strategy (REMS) in regards to transmucosal immediate-release fentanyl (TIRF) products.
The researchers from John Hopkins University released a public testimony through the New York Times, detailing their preliminary findings concerning how the REMS was functioning, raising a number of concerns.
The REMS was designed to ensure that only patients who were opioid tolerant, had cancer, and were duly educated on the risks of using TIRF products were prescribed the treatments.
In the statement by Caleb Alexander, co-director of John Hopkins Center for Drug Safety and Effectiveness, and Joshua Sharfstein of John Hopkins Bloomberg School of Public Health, said “preliminary findings indicate that the TIRF REMS programme has generated red flags for years. There have been multiple warnings that many providers have been engaged in inappropriate prescribing, placing patients at risk.”
In particular, through a Freedom of Information request, the researchers found that in April 2016 the FDA received data from commercial health plans revealing 51% of patients receiving TIRFs were not opioid tolerant – followed by further analyses confirming that between 44.6% and 65.4% were opioid tolerant.
According to the researchers, an assessment held in February 2017 found that 18.4% of prescribers and 47.7% of patients believed that TIRFs were FDA approved for chronic, non-cancer pain.
TIRF products are particularly dangerous because they're fast-acting and powerful, potentially leading to respiratory problems in users who are not opioid tolerant.
FDA responds to criticism
FDA Commissioner Scott Gottlieb made comments on Twitter regarding the topics of discussion at the advisory committee, suggesting that the comments provided would be used to address the shortcomings of the strategy:
4/6 Important feedback today: there are gaps in data on use of these products and adverse events. We need to use every tool available to examine the real-world impact of these drugs and the REMS program, and align our approach to strike better balance between access and safety— Scott Gottlieb, M.D. (@SGottliebFDA) August 3, 2018
In a press release prior to the advisory committee, the Agency noted that the implementation of the REMS had coincided with the “significant decline in prescribing of TIRF products and currently they are only prescribed to approximately 5,000 patients nationwide.”
The FDA has made it a focus to combat the ongoing opioid epidemic in the US through various routes, which has also resulted in companies now seeking to formulate treatments to avoid the dangers of opioid overdose.