Wednesday, June 30, 2021

MFIA Team Works on Medical Transparency Amidst Pandemic

Atmospheric photo of the exterior of the Sterling Law Building

The Media Freedom and Information Access Clinic (MFIA) worked through the fall 2020 semester with faculty from the Yale School of Medicine, Yale School of Public Health, and other public health experts and activists to ensure that the COVID-19 vaccine approval process was fully transparent and driven by science rather than political pressure. 

The COVID-19 transparency and accountability team brought pressure to bear on the Department of Health and Human Services, asking them to release information regarding the protocols that were governing the clinical trials used to test the safety and efficacy of the vaccines. During a period of widespread mobilization around vaccine development, the Clinic argued that the politicization of public health agencies under the Trump administration was exacerbated by the lack of transparency. 

Under normal circumstances, trial protocols — along with some trial data — would be released upon FDA approval of a vaccine. Because of the unprecedented rush to produce a vaccine under “Operation Warp Speed,” however, the COVID-19 vaccines in the United States were being approved for use under Emergency Use Authorizations, which do not require disclosure of drug trial information. The Clinic worked to encourage transparency in this type of rapid vaccine trial, development, and approval process. The Emergency Use Authorization (EUA) statute was not designed with pandemic response in mind, which led the FDA to issue a set of additional guidelines describing the safety standards it would use in issuing EUAs for COVID-19 vaccines — standards which exceed those required by the law. 

The Clinic engaged in various types of advocacy throughout the vaccine approval process, including urging vaccine manufacturers to release information about their trials so that independent researchers could evaluate their data. In this case, advocacy, rather than litigation, was the strategy of choice for the Clinic, considering the “warp speed” of this process and the urgency of the pandemic. 

The Clinic also looked into how government contracts were being awarded in the process of data management, vaccine distribution, and logistics, to ensure there was no abuse of power in these processes. The overall goal was to weave a culture of transparency into emergency use authorization proceedings and ensure government agencies are doing everything they can to bolster integrity and credibility. 

“One of MFIA’s main missions is to promote government accountability and transparency,” says MFIA student Sam Aber ’22. “We didn’t want people to be hesitant to get the vaccine. Secrecy breeds mistrust. Greater transparency around drug and vaccine approvals, clinical trial data, and medicine more broadly is something we see as public good, and something that will benefit the public health in the long run.”

The project was made possible thanks to the leadership of Professors Gregg Gonsalves (Yale School of Public Health) and Amy Kapczynski ’03 (Yale Law School), as well as former MFIA fellows John Langford ’14 (Protect Democracy) and Chris Morten (NYU School of Law).

MFIA is a law student clinic 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.

By Leah Ferentinos