The world is facing a health crisis at a level it has not experienced in generations. The U.S. and countries worldwide are grappling with how to best protect citizens in the wake of the transmission of the SARS-CoV-2 virus and the resulting coronavirus disease 2019 (COVID-19) pandemic. Throughout its history, the U.S. Food and Drug Administration (FDA) has always been responsive to public health demands. Never has that been truer than today as COVID-19 spreads rapidly across this country and the world. The agency has been moving quickly to address this virus from a detection, prevention, and treatment standpoint. Both FDA’s and Congress’ prior experience with public health crises can serve as valuable guidance to the pharmaceutical and biotechnology industries as they ramp up efforts to combat COVID-19. However, to be successful, the FDA and the pharmaceutical and biotechnology industries will need to work together in a concerted effort.
FDA’s History of Dealing with Health Crises and Threats
From the AIDS epidemic in the 1980s and the Anthrax scare in the aftermath of 9/11, to more recent threats such as H1N1 (Swine Flu), the Ebola virus, SARS and the Zika virus, facing and tackling nationwide health crises are nothing new for the federal government. As these situations have arisen over the years, Congress and FDA have evolved the regulatory system to address each of them in various ways.
For example, in response to 9/11, FDA created the Office of Counterterrorism and Emerging Threats (OCET), and in 2010 OCET created the Medical Countermeasures Initiative. In response to health emergencies, numerous regulatory procedures for expedited review of drug products and medical devices have been created, including fast-track and breakthrough therapy designations as well as accelerated review processes. Emergency Use Authorizations (EUAs) and expanded access (compassionate use) pathways exist to treat patients with serious or other life-threatening health issues when there are no alternative treatment options available. Even creative regulatory review procedures, such as the “animal rule” that permits approval largely based on animal studies when human testing of a medical countermeasure is not practical, have been implemented to accelerate or otherwise make it easier to approve certain products in times of need.
Working With the FDA to Triage Coronavirus
Right now, the public is focused on availability of and access to coronavirus tests and improvements to the test development system. People are also looking for treatments to help those who have been impacted by the virus, and they are calling for the development of vaccines that can stop the spread of COVID-19 as quickly as possible. It is an uneasy time, and people want answers quickly. They expect FDA to be nimble enough to respond in real time.
Historically during health crises, it has been emerging companies and academics that have strongly called for more Congressional funding. However, those investments typically go to big pharma, big bio, and big device companies. With their FDA experience, these companies have an advantage when working with regulators on product approvals. Companies are already initiating clinical trials on COVID-19 treatments with Investigational New Drug (IND) applications. Just this week, the FDA granted an EUA for Roche’s Cobas SARS-CoV-2 Test to detect the virus. More announcements about products in development are being made almost daily. We expect this trend to continue for the foreseeable future.
Currently, the FDA is acting rapidly on all ideas it is presented with regarding COVID-19. Still, that does not mean that the agency will make drastic changes to its traditional drug and biologics approval approach. Right now, the FDA is still funneling all COVID-19 ideas and concepts it receives through its normal regulatory schemes. Overloading the FDA with requests for expedited review, compassionate use, exportation, importation, or other accelerated review and approval methods will only serve to clog the system. Based on our experience, these requests will likely be triaged out, recycled, or put on the back burner as FDA attempts to eliminate the noise from the potentially viable treatments.
Standing Out by Following Process and Procedure
Companies that understand the regulatory process and present their data and information in a standardized manner that the FDA can easily understand and assess will undoubtedly have an advantage. In times of crisis—just as it is in more routine circumstances—it is imperative to use a structured review and approval process that is based on a viable scientific hypothesis. Additionally, but equally as importantly, those companies and individuals that have data to share will have a stronger case for advancement and can more easily support their application’s premise. Assertions and theories can (and will) move forward, but a hypothesis must be thoughtfully and scientifically established. Following the FDA’s historic process dramatically increases the likelihood of moving a potential treatment forward.
Obviously, elected officials and regulators want to quickly address this evolving health crisis. At this point, there is no benefit to delay. As Roche has shown, companies that have filed INDs and that are using other traditional methods of FDA review and approval have moved quickly. New entrants to the FDA process that have untested hypotheses, that have not dealt with the regulatory system, and that complain of bureaucratic delay will seldom get very far. Those that see success have recognized that talk is irrelevant with FDA—following the established regulatory processes is the only way forward.
In these uncertain times, the key to surviving in the pharmaceutical and biotechnology space is in the quality and quantity of data, just as with conventional FDA submissions. While it is not critical (and, in this environment, not recommended) to wait until all the data on a submission is available, it is necessary to present a sound hypothesis with enough supporting data in an articulate and thorough manner to realistically move a product through the FDA. Although the agency has the benefit of more than a century of experience—as well as novel review and approval mechanisms that can speed approval—the FDA will always adhere to its standard of safety and effectiveness.