Balancing Hope and Proof: Investigational Products During the COVID-19 Pandemic

On October 2, 2020, the White House announced that President Trump received an investigational antibody cocktail (REGN-COV2) for COVID-19 made by Regeneron Pharmaceuticals, Inc. REGN-COV2 is still in clinical trials and has not been approved for any use by the Food and Drug Administration (FDA). In general, the federal Food, Drug, and Cosmetic Act (the Act) prohibits “new” drugs and biological products (such as antibodies and vaccines) from being introduced or delivered for introduction into interstate commerce without prior approval from the FDA.¹ A commonly understood exception to this prohibition is that new drugs may be shipped for FDA-regulated clinical trials under an Investigational New Drug application (IND) pursuant to 21 C.F.R. Part 312. President Trump, however, did not participate in the clinical trials studying REGN-COV2. So how did he get this experimental product?