DURHAM, NC -- Two former Food and Drug Administration (FDA) commissioners want the agency to form a pair of task forces focused on bolstering both testing and care to help curb the spread of the coronavirus.
In addition, the commissioners urge the White House to accelerate steps on a nationwide COVID-19 surveillance partnership to support these efforts and seek further interventions.
“We need these drugs and testing tools to help patients now. We also need them for the long term,” write former FDA commissioners Drs. Scott Gottlieb and Mark McClellan in a working paper issued Thursday by the Duke-Margolis Center for Health Policy.
“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.”
One task force would focus on rapid development of point-of-care diagnostics; the second would target rapid development of effective therapeutics and prevention.
The efficient launch of medical products to combat current and future outbreaks of COVID-19 requires support of the FDA to work with manufacturers developing and delivering diagnostic tools, therapies and prevention strategies, they write.
Gottlieb and McClellan contend that the FDA can support large-scale access to different drugs that have shown they may be effective against the coronavirus, while also studying 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 of 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.