FDA transparency practices are a barrier to global health

Over the course of the COVID-19 pandemic, scientists from the U.S. Food and Drug Administration (FDA) generated large amounts of data through their review of pandemic-related tests, medications, and vaccines. However, in a Policy Forum, Murray Lumpkin and colleagues argue that longstanding confidentiality practices at the FDA have prevented the agency from sharing critical data with many other regulatory agencies around the world, particularly those in low- and middle-income countries. “Successful U.S. leadership in the modern global pharmaceutical ecosystem, as well as global health and safety, depends on the ability of regulators to trust each other and work together,” Lumpkin et al. write. “In the 21^st century, sharing data and critical documents among regulators cannot be an afterthought: it must be ‘business as usual,’ including for the FDA.” According to the authors, the pandemic has made clear that the FDA’s current sharing practices, which were developed decades ago, have left the agency isolated and have undermined the ability of other nations to use its information to make informed and prompt regulatory decisions on critical public health issues. New transparency policies that enable greater data sharing with other regulators worldwide will promote U.S. scientific and regulatory leadership and advance global health. Lumpkin et al. offer several suggestions that could help achieve this goal, which include waiving the FDA’s current practices so that the assessment and inspection reports for all pandemic-related products can be shared; developing new practices on data-sharing with the World Health Organization and counterpart agencies outside of public health emergencies; and publishing annual reports of its data-sharing activities with counterpart regulators to ensure continued success.