FDA, Take Note: There Can Be No Trust Without Transparency

Americans are worried—and they should be. The past two years of the COVID-19 pandemic have given many people an unexpected crash course in pandemic politics, allowing them to witness firsthand the high level of control that government can exert on our daily lives. Trust in government, particularly at the federal level, is rapidly declining, fueled in large part by the government’s own pandemic-related missteps.

Considering their numerous miscues, poor communications, and arbitrary rules that aren’t backed by science or medicine, it should come as little surprise that the highest-profile federal agencies during the pandemic, the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), are viewed favorably by only 40 percent of Americans, making both nearly as unpopular as the Internal Revenue Service (IRS). We don’t know what the future of COVID-19 looks like, but lawmakers and leadership within these agencies should prioritize improving transparency and restoring public trust.

The lack of transparency is well-documented. Take, for example, a Freedom of Information Act (FOIA) request filed by researchers seeking the data used to approve a COVID vaccine. If the FDA got its way, it may have taken until 2097 for all the relevant documents to be released.

Thanks to a recent federal court ruling, the FDA is now required to fulfill that request this year. But it is outrageous that the FDA had to be hauled into court to ensure transparency in the processes that it uses to make important decisions about the treatments that are made available—or not made available—to Americans.

This information should never be a government secret—it shouldn’t take an army of lawyers and a legal battle to learn how and why the FDA makes decisions about who gets access to treatments, especially when those decisions can have life-or-death consequences. That information is supposed to be readily available to all Americans. Transparency, not secrecy, should always be the default.

Unfortunately, this attempt to evade transparency isn’t an isolated incident. The Goldwater Institute has repeatedly sought clarification from the FDA regarding its approval processes. For example:

*In 2014, Goldwater asked the FDA why it allowed two American aid workers infected with Ebola to use an experimental treatment that had not been tested on humans, while denying countless Americans with terminal illnesses access to treatments that had undergone years of human trials. The FDA refused to respond, and only after a lengthy court battle was it forced to release these records.

*In early 2016, Goldwater sought information from the FDA about its processes for requesting investigational treatments outside of clinical trials. It took five years and legal action before the FDA finally fulfilled the request.

*More recently, Goldwater asked why the FDA interfered with a doctor’s treatment recommendations for his dying patient, especially when the doctor believed the FDA’s recommendation would be ineffective and possibly dangerous. After all, the FDA is not supposed to regulate the practice of medicine. So far, the FDA has ignored that request.

The pandemic has laid bare the fact that the federal government wields enormous power over our individual lives. Americans deserve to know who is responsible—and debate who should be responsible—for making these crucial decisions, as well as the parameters used to make them.

Naomi Lopez is the Director of Healthcare Policy at the Goldwater Institute and a contributor to Putting Patients First: Unleashing Innovation in American Healthcare, a blueprint for FDA reform.