To embed, copy and paste the code into your website or blog: Following up on our colleagues’ post earlier this month covering the Food and Drug Administration’s 2020 device law and policy activities, this post will explore prescription drug and biologic law and policy developments over the past year. We’ll also begin looking forward into 2021 and the agency’s transition to an incoming Biden Administration. One of the highest priorities for the Food and Drug Administration (FDA) during this “pandemic year 1” was authorizing the use of COVID-19 medical countermeasures. Another high priority was policing fraudulent COVID-19 drugs, preventative products, herbal cures, and even vaccines (not to mention fake test kits, personal protective equipment, and other things regulated as medical devices). As of December 18, 2020, FDA had sent more than 150 warning letters to peddlers of fraudulent COVID-19 products, many in conjunction with the Federal Trade Commission (FTC) – and we expect enforcement activity will be increasing next year as the pandemic continues into “year 2.”