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Former FDA commissioners prompt Biden to nominate permanent head

The commissioners highlighted the FDA's role in the pandemic response, including issuing guidance on vaccines and drugs.

Jeff Lagasse, Associate Editor

President Biden (Photo by Doug Mills-Pool/Getty Images)President Biden (Photo by Doug Mills-Pool/Getty Images)

President Joe Biden has yet to nominate a permanent head of the Food and Drug Administration, but six former FDA commissioners are urging him to do just that, citing the ongoing COVID-19 pandemic as a reason to do so.

Specifically, the commissioners highlighted the FDA's role in the pandemic response, which has included issuing guidance on modernizing vaccines and drugs to keep up to speed on new coronavirus variants. 

The commissioners also said that the FDA is protecting consumers with enforcement actions against unproven products that made misleading coronavirus-related claims.

"The coming days and weeks will require further timely and effective actions, for example to support the development of antiviral treatments and advance the availability of reliable, easy-to-use tests," the commissioners wrote in their letter.

WHAT'S THE IMPACT?

While statistics show the spread of COVID-19 is slowing amidst a massive vaccination push, the coming days and weeks will still likely prove critical. Timely action will be needed, for example, to support the development of antiviral treatments and advance the availability of reliable, easy-to-use tests, the commissioners said.

"At the same time, the FDA must continue to advance its work across its uniquely broad and diverse portfolio," they wrote.

"For example, the agency is implementing new regulations for tobacco products to reduce death and disease from cigarettes, implementing new food safety provisions, making more biosimilar drugs available at a lower cost, and taking enforcement actions against manufacturers for misleading claims."

Praise was reserved for the Biden Administration in terms of its support for science-based regulatory approaches, which the commissioners insinuated was a departure from the modus operandi of Biden's predecessor, former President Donald Trump. 

The letter also praised Dr. Janet Woodcock's handling of her duties as acting commissioner during the interim, saying that experienced leadership reinforces the agency's commitment to scientific rigor and evidence-based decision-making.

Woodcock was therapeutics lead for Operation Warp Speed, the Trump Administration initiative to speed up development of an effective COVID-19 vaccine.

According to the New York Times, Woodcock is a leading candidate for the permanent job, as is Dr. Josha Sharfstein, associate dean for public health practice and training, and professor of the practice in health policy and management, at Johns Hopkins Bloomberg School of Public Health in Baltimore.

"To continue to advance the agency's mission, and promote its independent role, we urge you to prioritize securing its leadership team, including through seeking the formal nomination and confirmation of an FDA Commissioner," the letter reads.

"The agency's experienced staff and its science-based regulatory processes will play a critical role in helping the nation confront the evolving pandemic."

The letter was signed by Dr. Robert Califf, Dr. Scott Gottlieb, Dr. Margaret Hamburg, Dr. Jane Henney, Dr. Mark McClellan and Dr. Andrew C. von Eschenbach.

THE LARGER TREND

While no official nominations for FDA commissioner have yet been made, the administration has been busy filling other posts, including naming Elizabeth Richter as acting head of the Centers for Medicare and Medicaid Services.

Biden has also nominated California Attorney General Xavier Becerra to serve as his Health and Human Services secretary, although that nomination has not been confirmed.

President Biden and Vice President Kamala Harris have a seven-point plan to beat COVID-19, including calls for doubling the number of drive-through testing sites; investing in testing, including at-home tests and instant tests; and setting up a Pandemic Testing Board, not unlike Roosevelt's War Production Board.

The plan calls for establishing a U.S. Public Health Jobs Corps to mobilize at least 100,000 Americans across the country, with support from local organizations in communities most at risk, to perform culturally competent approaches to contact-tracing and protecting at-risk populations.
 

Twitter: @JELagasse
Email the writer: jeff.lagasse@himssmedia.com