Former FDA Commissioners Gottlieb and McClellan propose actions to speed COVID-19 countermeasures

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FDA should create task forces to facilitate the rapid development of point-of-care diagnostics, therapeutics and prophylactics for COVID-19, former FDA Commissioners Scott Gottlieb and Mark McClellan recommended in a working paper released Thursday.

They also called for the creation of a public-private partnership, led by the White House, to create and operate a COVID-19 surveillance system.

“We can support large-scale access to different drugs that have shown they may be effective against the coronavirus in a framework that enables us to collect good information to determine which medicines are working best for patients, and ultimately merit full FDA approval,” Gottlieb and McClellan wrote. “At the same time, we can advance treatments that can help protect people from becoming infected with coronavirus in the first place. We also need more tools for early detection of the virus so we can prevent future outbreaks.”

Gottlieb is a resident fellow at the American Enterprise Institute, partner at New Enterprise Associates, and board member of Pfizer Inc. (NYSE:PFE) and Illumina Inc. (NASDAQ:ILMN).

McClellan is director of the Duke-Margolis Center for Health Policy and an independent director on the boards of Alignment Health Care, Cigna Corp. (NYSE:CI), Johnson & Johnson (NYSE:JNJ) and Seer Inc.

Gottlieb and McClellan urged FDA to create task forces headed by Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), and Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH).

The CDRH task force could work with manufacturers and other government agencies to speed the creation and deployment of COVID-19 point-of-care diagnostics. It would, Gottlieb and McClellan suggested, develop common protocols; agree on validation steps and timelines; determine which testing sites could be used; identify and address long-term supply chain needs; clarify applicability of Emergency Use Authorization authority; and clarify CLIA waiver rules.

The CDER task force would start by identifying the most promising therapies and prophylactic agents, including both new and repurposed drugs, and then work with manufacturers to create an efficient trial network to test them.

The initiative to collect data on safety and efficacy should “leverage master protocols that incorporate data from ‘real-world’ digital sources to simultaneously evaluate more than one investigational drug within the same overall trial structure,” wrote Gottlieb and McClellan. They also recommended the use of “expanded access-like enrollment” so data collection can be integrated into clinical care.

In addition to facilitating the development of diagnostics and drugs, Gottlieb and McClellan argued that a comprehensive surveillance system is essential, and called for adapting and dramatically expanding the influenza like illness (ILI) surveillance network to detect COVID-19 "at nationwide scale."

Further analysis of the coronavirus crisis can be found at https://www.biocentury.com/coronavirus.

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