The COVID-19 pandemic has resulted in a major shift in FDA regulatory and enforcement priorities and has had a drastic impact on the broader regulatory landscape. At the end of 2019, the agency was focused, among other issues, on opioids, youth vaping, food safety, compounding and overhauling the regulatory framework for dietary supplements. Today, FDA is focused on helping industry bring to market drugs, devices and vaccines critical to fighting the pandemic. Its enforcement efforts are focused on those who peddle false cures or distribute counterfeit or otherwise poor quality products. The world has changed, and with it the regulatory environment.
FDA has issued guidances and templates to help industry develop substantive emergency use authorization requests with sufficient information to enable effective and streamlined review, exercised enforcement discretion where it deemed the benefits outweighed the risks, and waived regulatory requirements to help get products to market quickly. And FDA has indicated its willingness to “course correct” when evidence has demonstrated that the agency’s flexibility resulted in more harm than good. FDA is also providing significant trial design assistance and wading into thorny ethical issues in connection with the race to develop a vaccine.
There may be long-lasting effects from the pandemic even after the immediate threat abates. Going forward, companies may opt to reevaluate their supply chains, taking into consideration the shortages seen during the pandemic attributable in part to the country’s reliance on foreign sources of API, finished drugs, and devices like N95 masks. FDA has also shown willingness to use real world evidence as it evaluates COVID-19 therapeutics and has welcomed digital health applications that enable remote monitoring of clinical trial subjects and remote evaluation and treatment of sick patients. Certain changes may remain after the pandemic subsides and the current public health emergency declaration is lifted.
In this webcast, Beth P. Weinman (Ropes & Gray LLP) and Jennifer Mallory (Nelson Mullins Riley & Scarborough LLP) will address the above topics as they provide an overview of the impact of COVID-19 on the FDA regulatory environment.