New report offers roadmap for FDA to rebuild public trust

The US Food and Drug Administration (FDA) should adopt a series of reforms to rebuild the public trust it lost during the COVID-19 pandemic, including adopting consistent rules, ensuring that decisions are made by the appropriate personnel, and making sure there is no political interference in its decisions, according to a new report from the Hastings Center.
 

“The events surrounding the Covid-19 vaccine approval raise a fundamental question about the role of political influence at the FDA: how can the agency maintain its trustworthiness while respecting both scientific expertise and political values through accountability to democratically elected officials?” Leah Rand, a research scientist with the Program on Regulation, Therapeutics, and Law (PORTAL) at Brigham and Women’s Hospital in Boston, and her colleagues wrote.

While some of these recommendations have already been adopted by FDA, the agency’s next steps should include establishing a “coherent agenda” to build agency trustworthiness, the authors wrote.

Ensuring consistency

The report notes that FDA generally seeks to be transparent in commu­nicating its expectations for what is required for approval, and the agency did a good job in setting those expectations through its guidance for developing vaccines for COVID-19.

“Its guidance for Covid vaccines, issued in the summer of 2020, responded to public concerns about rushing the approval of low-efficacy vaccines and provided assurance that the FDA would not let political pressures affect its decision-making…..Although the guidance was issued during the pandemic rather than ex ante, it is a good example of setting clear evidence standards that should be met for vaccine approval,” the authors wrote.

FDA should also ensure that decisions are made by the appropriate staff. For example, staff with technical expertise and those with political skills have different areas of expertise that should be brought to bear for decisions in their respective areas.
 

“Being a scientific expert is distinct from being expert or authoritative on political or public values. Decisions like what minimum efficacy and maximum safety requirements should be set as thresholds for vaccines are, in part, value judgments and so should be informed by scientific expertise and made in consultation with appointees, who act as an interface between the agency’s mission to serve the public’s  health  and  social  values  as  revealed  through elections,” they wrote.

Greater FDA independence

The report also recommends that FDA act as a more independent agency that is free from external influences. Specifically, the authors suggest that the agency’s model itself on the organizational structure of the Securities and Exchange Commission (SEC) or the Federal Trade Commission (FTC), which limits the US president's power to remove commissioners.

FDA should also be required to issue more detailed reasoning when it rejects the decisions made by its expert advisory committees. The authors pointed to FDA’s decision to approve hydrocodone (Zohydro) over the recommendation of its advisory committee. Rejections advisory committee recommendations can cause “controversy and investigations into the processes and reasons behind its ultimate decisions,” the authors wrote.

Hastings report