Former FDA Commissioners Mark McClellan, MD, PhD, director of the Duke-Margolis Center for Health Policy, and Scott Gottlieb, MD, made recommendations for how the FDA should respond to the novel coronavirus outbreak.
Efficiently launching medical products to combat the current and future outbreaks of COVID-19 requires supporting the Food and Drug Administration’s (FDA) work with manufacturers that have high potential to develop and deliver needed diagnostics, therapeutics, and prophylactics, stated former FDA Commissioners Scott Gottlieb, MD and Mark McClellan, MD, PhD, in a working paper issued recently by the Duke-Margolis Center for Health Policy.
The co-authors call for FDA to establish two task forces: one focused rapid development of point of care (POC) diagnostics; the second focused on rapid development of effective therapeutics and prophylaxis. In addition, the commissioners urge the White House to accelerate steps on a nationwide COVID-19 surveillance partnership to support these efforts and help target further interventions.
“We need these drugs and testing tools to help patients now. We also need them for the long term,” said Drs. Gottlieb and McClellan (pictured right). “With the isolation and other steps we are taking now, it’s possible that the epidemic spread of coronavirus will wane in the coming weeks and months. But it’s also possible that there will be additional waves of viral spread with the risk of another epidemic in the future.”
To meet current and future needs, the co-authors contend that the FDA can support large scale access to different drugs that have shown they may be effective against the coronavirus in a framework can collect good information to determine which medicines are working best for patients, and ultimately merit full FDA approval. “At the same time, we can advance treatments that can help protect people from becoming infected with coronavirus in the first place,” said the co-authors.
The white paper details how the FDA could structure the recommended task forces as well as the goal of each entity. The paper also defines how establishing a public-private partnership can help to ensure more comprehensive national surveillance COVID-19 to prevent the current and possible future waves of infections.
Dr. Gottlieb is a resident fellow at the American Enterprise Institute and was Commissioner of the Food and Drug Administration from 2017-19. Dr. McClellan, who directs the Duke-Margolis Center for Health Policy, was Commissioner of the Food and Drug Administration from 2002-04.