The U.S. FDA has taken unprecedented actions during the COVID-19 crisis to bolster medical supplies, rush testing to market, and help develop potential treatments. The actions have had both positive and negative consequences, which are just beginning to emerge.
On a big picture level, the FDA’s response during COVID-19 will provide a guide for what to expect when the next public health emergency occurs in the U.S. But from a day-to-day perspective, the pandemic could lead to major changes as well, and impact how the FDA regulates and polices products; how it develops treatments for broad distribution and experimental use; how it interacts with the public, private companies, charities, and other entities; and how it conducts and drives research.
A few themes have emerged from the responses to COVID-19 that could become institutionalized. The FDA is historically notorious for its caution — for the extended vetting, testing, and inspecting it performs on medical products to make sure they are both safe and effective before they are allowed on the market. During the crisis, however, the agency stepped back from its gatekeeping role, allowing some products to be commercialized without FDA review or with much less evidence than traditionally required. We foresee that trend continuing, reflecting a shift away from prevention and towards enforcement, with the agency encouraging new products and treatments to reach the public as soon as possible.
COVID-19 has also changed how the FDA handles the monitoring of products and devices once they are on the market. For several FDA-authorized COVID-19 medical devices, the unique identifier requirements of the agency are not enforced. When issues arise related to such COVID-19 devices, the FDA can only take broad action rather than pinpoint and solely remove the noncompliant product. In addition, some products no longer require the manufacturer or distributor to monitor for adverse effects. The FDA instead has relied on the public, watchdog groups, and competitors to flag products as harmful or, more often, not effective.
The collaborative efforts seen during COVID-19 are another element likely to remain post-crisis. The FDA has entered into partnerships with established companies to speed up testing, treatments and product supply. The FDA is also collaborating with other government agencies; for example, it is working with the National Cancer Institute to test and validate products released on the market without screening. The FDA is working closely with nonprofits and universities, particularly with respect to the development of new treatments.
We also foresee that the FDA will continue to develop standards for products, innovation, testing and treatment. While FDA does not require compliance with these standards, they have been streamlining the development process. For example, the agency has made simplified guides to help new companies produce authorized medical devices like hand sanitizer and face masks. The agency has employed these protocols as part of its efforts to accelerate the development process.
While it is likely the FDA will continue to reduce certain requirements for products to enter the market, bad actors and current adverse events will shape how the agency implements such changes in a post-pandemic world. For example, the FDA has greatly reduced the requirements for producing alcohol for alcohol-based hand sanitizer, as well as for the production of hand sanitizer itself. Following these changes, the agency has been made aware of a steep increase in calls to the National Poison Data System related to hand sanitizer.
These adverse events — due, at least in part, to a failure of producers to properly follow reduced guidelines issued by the FDA — highlight the importance of the FDA’s oversight and will also shape how the agency exercises its authority in the future.