The Hastings Center recently released a report with a roadmap on how the United States Food and Drug Administration (FDA) can rebuild public trust since the COVID-19 pandemic. The authors of the report propose five conditions of trustworthiness that the FDA should meet when it reviews vaccines – even in emergency circumstances like the COVID-19 pandemic. The five conditions are: (1) consistency with rules, (2) proper expert or political decision-makers, (3) proper decision-making and noninterference, (4) connection to public preference, and (5) transparency of both reasons and procedures.
Consistency
The report notes that the FDA typically tries to be transparent in communicating expectations for what is required for approval, and that even the guidance in developing vaccines for the COVID-19 virus did a good job at setting those expectations. “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.
Even still, the authors note that the agency should ensure that decisions are being made by the proper staff, including staff with the requisite technical expertise. While staff with political skills also serve a purpose, they should be brought in to handle a different part of the process that they have the skillset for. Essentially, staff with different areas of expertise should be brought in on decisions that deal with their respective areas of expertise. “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.
Independence
The report also takes issue with the way White House officials seemingly pressured the FDA in 2020 to authorize COVID-19 therapies and approve a vaccine prior to the November 2020 election. The report does make sure to note that “[d]espite political pressure, the FDA acted consistently with its rules of review, including follow-up safety plans for vaccine authorization, which were not supported by political officials.”
The report also notes that there will be policy decisions that need to be made, such as which applications to prioritize in review or approval, but those policy goals should not be injected into individual scientific decisions, such as whether clinical studies show a vaccine or drug to be effective. “Setting boundaries for political influence on technical, scientific decisions is necessary to prevent problematic interference in agency decisions,” the authors note.
Transparency
The authors also covered transparency and the two roles it plays in the process: (1) to share with the public the reasons for a decision, so people can make sense of and evaluate its appropriateness and the extent to which it is consistent with the agency’s mission and (2) to show that the agency is meeting all conditions of trustworthiness.
The authors went on to state that “[b]eyond data sharing, the FDA should provide its interpretation of the data and how that informs its decision in ways that are clearly explained and easily accessible to the public.” Additionally, in instances where the FDA deviates from advisory committee recommendations, the agency should “be required to issue more detailed reasoning for its decision.”