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Saturday, January 22nd, 2022

FDA continues operating without a Senate-confirmed, permanent leader

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The U.S. Food and Drug Administration (FDA) remains without permanent leadership during the nation’s ongoing battle against the COVID-19 pandemic.

“It’s of top concern that President Biden still has not nominated someone to serve as permanent FDA commissioner,” a House Energy and Commerce Republican aide told Homeland Preparedness News. “Why hasn’t this been a priority after more than eight months into his presidency, especially to ensure public confidence in vaccine approvals?”

Pressure on the president to make an FDA nomination is mounting as the current Acting FDA Commissioner Janet Woodcock’s term ends on Nov. 15. People want to know: What’s the plan?

Right now, according to White House Press Secretary Jen Psaki, there isn’t one.

“I promise you when we have determined and selected an FDA commissioner to nominate, we will announce it,” Psaki said during a Sept. 16 press briefing. “I don’t have any predictions of what the timeline will be.”

The FDA plays a major role in the federal government’s preparedness and response to the pandemic, such as by expediting access to COVID-19 medical countermeasures for the detection, protection against, and treatment of COVID-19, according to agency staff.

The FDA also is supporting the stability and quality of medical product and food supply chains, and ensuring that its decisions are guided by science using an open and transparent process, agency staff say.

Acting FDA Commissioner Woodcock, who has served in the position since Biden took office in January, began her career with the agency in 1986. This year she has faced opposition from lawmakers on Capitol Hill who oppose her taking over as the permanent FDA chief.

U.S. Sen. Joe Manchin (D-WV), for instance — who holds a key swing vote in the evenly divided chamber — this summer voiced concerns to Biden about “the continued tenure of Dr. Janet Woodcock as interim commissioner.”

In a June 17 letter Manchin sent to the president, the lawmaker specifically took issue with the FDA’s approval for Aduhelm, a treatment for Alzheimer’s disease, despite its advisory panel voting nearly unanimously against its approval, with no panel member voting in favor of approval. 

“The FDA’s, and in particular Dr. Woodcock’s decision to go against its advisory committee’s decision, yet again has resulted in at least three scientists resigning from the committee,” Manchin wrote. “This brings into question the current interim leadership of Dr. Woodcock, at a time when strong, trusted leadership at our health agencies is most important.”

The senator noted that having a permanent agency head in charge to answer questions from patients and doctors on this approval, and to assure the general public of the FDA’s commitment to public health, “is imperative, and Dr. Woodcock is not the right person to lead the FDA.”   

Other experts pointed out similar issues under Woodcock’s leadership.

Diana Zuckerman, president of the National Center for Health Research, told Homeland Preparedness News in an email that a negotiation the FDA recently completed with industry regarding drug user fees “is entirely focused on pleasing industry with quicker approvals, and all but ignores whether the new drugs being approved are proven safe or effective.”

“What is critical is to have a permanent, Senate-confirmed FDA commissioner who understands that the American taxpayer is their customer, not the companies that make the products that the FDA regulates,” Zuckerman wrote. “Unfortunately, recent commissioners, including the current acting commissioner, have repeatedly referred to their goal of providing good customer service to industry.”

Zuckerman also said that while the FDA doesn’t have the authority to make decisions about vaccine or mask mandates, the agency does, for example, have the authority to ensure that the masks being sold to prevent COVID transmission are as effective as possible.  

“The FDA has failed to do that under the acting commissioner, and there really is no excuse for that,” said Zuckerman. 

And “while it has been obvious that the White House has made decisions that were supposed to be made by the FDA,” according to Zuckerman, she doesn’t think having a confirmed FDA commissioner will necessarily improve that situation.   

“It would be improved, however, by a commissioner who is dedicated to public health, knows FDA and the federal government well, and is not afraid to stand up for FDA’s public health mission,” she said.

Steven Grossman, executive director of the Alliance for a Stronger FDA, took a similar stance.

“As is the case now, FDA has been blessed with very strong interim leadership that has served the agency well,” Grossman wrote in an email to Homeland Preparedness News. “However, only a Senate-confirmed commissioner can make — and stand behind — long-term commitments on behalf of the agency.”

Grossman also explained that the FDA commissioner post can be difficult to fill. Among other things, the commissioner has 18,000 employees, jurisdiction so vast that it encompasses 20 percent of all consumer spending, and hundreds of decisions that need to be made each day, a substantial number of them time-sensitive and/or requiring commissioner involvement. 

“The commissioner should have a demonstrated understanding of public health, the medical product development cycle, and the difficulties of maintaining food safety across a nation of 330 million individuals,” he wrote. “The learning curve is incredibly steep for anyone who doesn’t have pre-existing familiarity with the agency and how it meets its multiple responsibilities.”

All of this is made much harder while fighting a pandemic and simultaneously assuring that none of the agency’s other responsibilities are short-changed, said Grossman.  

Such other responsibilities, in fact, include America’s simultaneous, ongoing fight against opioid use and related drug overdoses, according to Sen. Manchin.

“The FDA has played a critical role in this overdose epidemic by overseeing continuous approvals of stronger and more addictive opioids since the initial approval of OxyContin in 1995 – and Dr. Woodcock has been there for all of it,” Manchin wrote in his letter to Biden. “Dr. Woodcock has repeatedly ignored public health concerns and shown a dereliction of duty by not working to end this epidemic. It is blatantly clear that we must do more to address the drug epidemic that is impacting every American.”