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Member Research and Reports

Member Research and Reports

Johns Hopkins: Study Finds Inadequate FDA Oversight of Monitoring of Fentanyl Products

A study led by Johns Hopkins Bloomberg School of Public Health researchers suggests that the Food and Drug Administration (FDA) and manufacturers did not take action when evidence emerged that potentially lethal fentanyl products were being inappropriately prescribed to patients.

The study was published February 19 in the Journal of the American Medical Association.

The study was based on a review of 4,877 pages of FDA documents obtained through the Freedom of Information Act from years 2012 to 2017. The study revealed that, even as evidence emerged that as many as half of patients taking highly dangerous medications, known as Transmucosal Immediate-Release Fentanyls (TIRFs), should never have been prescribed them, the FDA and fentanyl makers did not review prescribing records of even a single physician to consider disqualifying them from an FDA monitoring program, which would have prevented them from prescribing the products.

“Both the FDA and the fentanyl makers failed to design and implement an effective monitoring program,” says study senior author Dr. G. Caleb Alexander, professor of epidemiology and medicine and co-director of the Center for Drug Safety and Effectiveness at the Bloomberg School.

TIRFs, are more dangerous than most prescription opioids due to their very high potency and rapid onset. TIRFs were approved by FDA only for adult cancer patients “who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.”

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