Pharmaceutical Regulation, Transparency, COVID-19, Vaccines and Drugs, Pandemic
Hard-won gains in the transparency of therapeutic product data in recent years1 have occurred alongside growing reliance by regulators upon expedited review processes.2 The concurrence of these two trends raises fundamental questions for the future of pharmaceutical regulation about whether the institutionalization of transparency will foster improved oversight of drugs, biologics, vaccines, and other interventions, or else, provide cover for a relaxing of regulatory standards of safety, effectiveness, and quality.3 The urgency of the COVID-19 pandemic, however, has brought this tension into immediate and sharp relief. During the course of the global health crisis, regulatory bodies have markedly expanded the number and use of expedited review processes for COVID-19 therapies, and at the same time, the proliferation of misinformation about any potential SARS-CoV-2 intervention4 reveals the limitations of recently implemented transparency measures.
Sterling Edmonds et al, "Transparency Too Little, Too Late? Why and How Health Canada Should Make Clinical Data and Regulatory Decision-Making Open to Scrutiny in the Face of COVID-19" (2020) 7:1 JL & Biosciences 1.