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As the market gatekeeper for new drugs and vaccines, the U.S. Food and Drug Administration (FDA) plays a fundamental role in the response to public health crises. During the COVID-19 pandemic, FDA’s response has been heavily criticized by public health experts, including current and former advisors to the Agency (Baden et al., 2020). The bulk of criticism has centered around FDA’s use of emergency use authorizations (EUAs) covering unapproved COVID-19 products. In at least two instances—the EUA covering chloroquine and hydroxychloroquine, and the one covering COVID-19 convalescent plasma—experts have pointed out that the data used by the FDA in support of an EUA was not “scientifically sound” (Baden et al., 2020) and that the Agency’s decision-making processes appeared to be driven by political pressure and extra-scientific considerations. While the long-term reputational damage to the FDA stemming from these EUA controversies has been discussed abundantly in the literature (Baden et al., 2020), there is a pressing need for short-term measures designed to lessen the growing levels of FDA mistrust. Timely interventions are critical because the EUA pathway is also being used to bring COVID-19 vaccines to market. We therefore propose the adoption of a mechanism designed to improve trust in the FDA emergency authorization process, including in the specific context of COVID-19 vaccines, in the form of an independent review body modeled after the now-defunct Congressional Office of Technology Assessment. We begin by briefly exploring the current climate of FDA vaccine authorization mistrust and then describe the proposed mechanism and its implementation.
Overall levels of trust in vaccines had been declining even before the pandemic (Figueiredo, 2020), leading to geographically localized resurgences of vaccine-preventable diseases like measles (Patel, 2019). While the causes of vaccine mistrust are highly heterogenous (Palamenghi, 2020), mistrust in governmental agencies has long been acknowledged as a contributing factor (Miyachi, 2020). This mistrust has grown substantially during the COVID-19 pandemic, especially in the case of the FDA, which is widely perceived as having departed from its usual data-driven review processes in response to external pressures demanding the quick review and authorization of COVID-19 treatments (Baden et al., 2020). As a result, we are witnessing a growing mistrust of FDA’s ongoing decision-making processes with regard to COVID-19 vaccines. The states of California, Washington, Oregon, Nevada and New York have announced the formation of independent scientific safety review bodies that will do their own review of FDA-approved COVID-19 vaccines (Newsom, 2020). Similarly, a committee representing Black physicians within the National Medical Association has announced the formation of an independent expert task force to review FDA-approved COVID-19 drugs and vaccines (Boodman, 2020).
There is a critical need for credible, transparent and independent review of medical products as a trust-building mechanism, as well as a check on pressures to depart from evidence-based decision making. But we fear that the proliferation of separate ad hoc bodies designed to function as a check on the FDA will simply further undermine overall trust in COVID-19 vaccines and do little to repair trust in the FDA as a vaccine regulator. Instead of this ad hoc approach, we propose the creation of a single independent body outside of the FDA but within the U.S. administrative apparatus that would have the authority, scientific expertise, and credibility to review—at its discretion—FDA authorizations in the context of COVID-19 vaccines. As described below, there is already an existing body that could be swiftly funded, populated and operationalized to respond to specific challenges surrounding trust in COVID-19 vaccines greenlighted through the EUA pathway. This body could provide the kind of credible and transparent review of the decision making leading to approvals of COVID-19 vaccines that would limit departures from evidence-based decision making and build public trust in the ultimate approvals. This proposal focuses on reducing the departure of emergency decisions from scientific, evidence-based decision making. These departures can lead to skepticism about emergency regulatory processes and increase hesitancy feelings about the products authorized under emergency frameworks.
Our proposed model follows an existing blueprint, looking to re-fund the Office of Technology Assessment (OTA), a well-respected non-partisan agency responsible for helping Congress navigate science and technology issues. The OTA was established by Congress in the Technology Assessment Act of 1972 and was active until it was defunded in 1995 (PU.S. Code §§ 471-481). For 23 years, OTA provided Congress, and the American public, with hundreds of high-quality, independent assessments of various technologies and scientific developments that have served as basis for policymaking and legislation (Houghton, 1974). Since 1995, numerous academics, scientists, and politicians have called for the re-funding and re-institution of OTA, which is still held in very high regard in academic and scientific circles (Federation of American Scientists, 2014).
Since OTA is still codified in U.S. law (2 U.S. Code § 471 et seq.), we argue that it already has the legal authority to review decisions made by the FDA and provide Congress and the public an unbiased assessment of the scientific merit of biomedical technologies, including vaccines, and—by extrapolation—an assessment of the scientific validity of FDA decisions to approve or authorize such technologies for public use. If Congress, however, wants to be explicit about its intent to have OTA review FDA decisions, we propose a very small addition to Section 472(c) of the Technology Assessment Act, in the form of a subsection that would explicitly spell out OTA’s authority to “provide assessment of adherence to scientific practices and standards by agencies and other institutions.” This approach is designed as an enhanced check on decisions made in the context of public health emergencies or other highly disruptive events, such as review of EUA decisions. It would provide an independent check on agency tendencies to diverge from evidence-based standards and practices under high pressure situations such as public health emergencies.
Implementation of our proposal would be neither complicated nor expensive. OTA had a staff of 10 people and a budget of around $30 million a year (in today’s value) (Sargent, 2020). Congress could thus refund OTA at a similar starting level and have it start its work almost immediately, operating on a relatively modest budget. Doing so would provide much-needed independent assessment of FDA’s emergency authorization of COVID-19 vaccines, and potentially other COVID-19 products. We recognize that adding yet another bureaucratic and resource-consuming layer to the already arduous process of bringing biomedical products to market may seem to some like a step in the wrong direction. However, we firmly believe that FDA’s self-inflicted injuries to its own credibility and their potential implications on vaccine-hesitancy and the public health require this kind of move. By taking immediate steps to emphasize transparency and scientific accuracy, our proposal contributes to rebuilding trust in both agency decision-making and FDA-regulated products by emphasizing the agency’s independence from public and political pressure. As such, it would be an important step in broader efforts to increase the trust ecosystem surrounding COVID-19 vaccines, as well as future vaccines developed to meet future emergency needs.