Experts urge reforms at FDA to rebuild trust

In a new report aimed at rebuilding trust in health care and science, leading experts urge the U.S. Food and Drug Administration to adopt five reforms to rebuild public trust amid controversies around vaccine approvals.

In "Securing the Trustworthiness of the FDA to Build Public Trust in Vaccines," Leah Z. Rand, Daniel P. Carpenter, Aaron Kesselheim, Anushka Bhaskar, Jonathan J. Darrow, and William B. Feldman recommend the FDA consider five major factors to maintain its trustworthiness as an organization and to enhance public trust in its decisions, including:

• Making decisions that are consistent with its existing rules
• Employing expert decision-makers
• Avoiding problematic interference from politicians
• Staying connected to public preference
• Providing transparency in its decision-making process

"The pandemic revealed that the FDA must navigate political interests, and its responsibilities to be accountable and make evidence-informed decisions, with missteps leading to a lack of trust," said Leah Rand, one of the authors who is a research scientist at Brigham and Women's Hospital and Harvard Medical School.

The authors state that "these five conditions, both procedural and substantive, are necessary for FDA trustworthiness, particularly when it conducts reviews and issues approvals, given that it is a government agency subject to political control."

The essay is part of a new Hastings Center special report, "Time to Rebuild: Essays on Trust in Health Care and Science," which explores the causes of the decline in trust in health and science and proposes pathways to rebuild in a series of articles.

"The scientific community must rebuild trust, and the authors of this article have given us five clear conditions for the FDA to regain the confidence of the American public," said Gregory E. Kaebnick, a senior research scholar at The Hastings Center and an editor of the special report.