Study Finds FDA Oversight of Fentanyl Prescribing Inadequate

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

A study led by researchers at the Johns Hopkins Bloomberg School of Public Health indicates the U.S. Food and Drug Administration and manufacturers did not take action when evidence emerged that potentially lethal fentanyl products were being prescribed inappropriately to patients. The study was published Feb. 19 in the Journal of the American Medical Association and was based on a review of 4,877 pages of FDA reports and other documents obtained through the Freedom of Information Act from years 2012 to 2017.

The materials involved were part of an FDA monitoring program but aren't routinely made available to researchers or the general public, according to the school's news release. The study revealed that, even as evidence emerged that as many as half of the patients taking highly dangerous medications, known as TIRFs, should never have been prescribed them, the FDA and fentanyl makers did not review prescribing records of any physician to consider disqualifying them from the 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," said the study's senior author, Dr. G. Caleb Alexander, M.D., professor of epidemiology and medicine and co-director of the Center for Drug Safety and Effectiveness at the Bloomberg School.

According to the release, more than 2 million people living in the United States have an active opioid use disorder and as many as 2-3 million more people have a lifetime history of such a disorder. Millions more report they non-medically use opioids yet may not fulfill formal diagnostic criteria of an opioid use disorder.

The study focused on Transmucosal Immediate-Release Fentanyls, or TIRFs, which are more dangerous than most prescription opioids on the market due to their very high potency and rapid onset of action. TIRFs are designed to get into the bloodstream within seconds and, because of their risks, 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."

The release says lawyers from Yale Law School's Collaboration for Research Integrity and Transparency represented the researchers through the FOIA process and successfully negotiated release of the documents. It also says in late 2011, FDA started a Risk Evaluation and Mitigation Strategy program that required all doctors, pharmacists, and patients to certify their understanding of the risks and proper use of these drugs in order to prescribe, dispense, or take a TIRF product. TIRF makers also were required to submit annual reports to FDA demonstrating their compliance with the REMS requirements.

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