MFIA/CRIT Team Supports Johns Hopkins Investigation of FDA Oversight of Fentanyl Products

This week, researchers at Johns Hopkins Bloomberg School of Public Health published a report in JAMA revealing that a third to a half of patients prescribed the powerful opioid painkiller, fentanyl, did not qualify for its use under the U.S. Food and Drug Administration’s (FDA) standards for appropriate use. These findings, filled with critical implications for public health and the nation’s ongoing opioid epidemic, were made possible by Johns Hopkins Bloomberg School of Public Health’s collaboration with attorneys and law students from Yale Law School’s Media Freedom and Information Access Clinic (MFIA) and Yale’s Collaboration for Research Integrity and Transparency (CRIT). MFIA and CRIT’s intervention — to compel the FDA to release documents on fentanyl prescribing under the Freedom of Information Act (FOIA) — opened the gates to the data needed by Caleb Alexander and his colleagues at Johns Hopkins Bloomberg School of Public Health for this important study.

The JAMA article, entitled “Assessment of the FDA Risk Evaluation and Mitigation Strategy for Transmucosal Immediate-Release Fentanyl Products,” describes years of inaction by that led to misuse of fast-acting products containing fentanyl, a powerful, risky, and highly addictive opioid drug. While the FDA created a supposedly strict Risk Evaluation and Mitigation Strategy (REMS) program to ensure that transmucosal immediate-release fentanyl products (TIRFs) are prescribed only to a limited group of opioid-tolerant cancer patients, the article reveals that as many as half of all patients receiving TIRFs were not opioid tolerant and thus should never have received them. The article further reveals that the FDA failed to monitor or disqualify any of the prescribing physicians who distributed TIRFs inappropriately and failed to reform the TIRF REMS program despite knowing for years that it was inadequate. The article concludes that “after 5 years of data suggesting that the [TIRF REMS] program did not effectively limit TIRF use to opioid-tolerant patients, few changes had been instituted” by the FDA. The FDA’s failure to regulate TIRFs effectively may have contributed to the broader opioid crisis, suggests an editorial in JAMA published alongside the article by the JHU researchers.

The Johns Hopkins researchers’ JAMA article is based on a trove of previously unseen documents obtained from the FDA. Working on behalf of the researchers, the Yale MFIA/CRIT legal team obtained over 4,000 pages of documents through a Freedom of Information Act (FOIA) request. The documents include various communications between the FDA and manufacturers of TIRFs, including annual reports on use of TIRFs submitted by those manufacturers. The FDA had previously kept all of these documents secret from the public. While Dr. Alexander filed an initial FOIA request years ago, the FDA delayed production and ultimately produced documents only after the Yale MFIA/CRIT team joined the FOIA effort.

“FOIA has proved critical in illuminating problems at the FDA and other agencies that have contributed to the opioid crisis,” said Christopher Morten, MFIA supervising attorney and staff attorney at CRIT. “At the same time, the FDA’s years of delay in responding to Dr. Alexander’s FOIA request and the fact that the FDA produced the requested documents — as is required by law — only after Yale MFIA/CRIT attorneys joined the effort shows some of the problems with FOIA. The FDA needs to be more responsive to FOIA requests and to improve its transparency in other ways.”

“We at MFIA are committed to improving government transparency and are glad to partner with Johns Hopkins in this effort,” said Sasha Dudding ’20, one of the MFIA students representing the Johns Hopkins Bloomberg School of Public Health researchers.

Adam Pan ’19, another member of the MFIA student team, said, “We’re proud to support the investigative work of Dr. Alexander and his team, and we believe that the public has a right to see the remaining documents.”

CRIT Executive Director Margaret McCarthy, MFIA supervising attorney Jennifer Pinsof, and former CRIT staff attorney Cortelyou Kenney have also contributed to the Yale MFIA/CRIT team’s legal work for Johns Hopkins Bloomberg School of Public Health.

The Media Freedom and Information Access Clinic (MFIA) is a law student clinic at Yale Law School dedicated to increasing government transparency, defending the essential work of news gatherers, and protecting freedom of expression by providing pro bono legal services, pursuing impact litigation, and developing policy initiatives. MFIA is a program of the Abrams Institute for Freedom of Expression at Yale Law School, and is funded by the Abrams Institute for Freedom of Expression, the Stanton Foundation, the John S. and James L. Knight Foundation, and the Laura and John Arnold Foundation.

The Collaboration for Research Integrity and Transparency (CRIT) is an inter-disciplinary initiative launched in 2016 at Yale Law School, Yale School of Medicine, and Yale School of Public Health, whose mission is to promote health by improving the integrity and transparency of biomedical and clinical research. Through research, advocacy, and litigation, CRIT is focused on ensuring that the clinical evidence that supports and informs our understanding of the safety and effectiveness of pharmaceuticals, medical devices, and other medical products is accurate, comprehensive, accessible, and reliable. CRIT is funded by the Laura and John Arnold Foundation and the Oscar M. Ruebhausen Fund at Yale Law School.