Biden struggles to find permanent FDA chief as agency nears Covid-19 vaccine approval
For months, the agency at the forefront of the coronavirus response has served under the direction of Acting Commissioner Dr Janet Woodcock as President Joe Biden struggled to find a candidate who could get confirmation of the Senate.
It is not for lack of trying. For months, key Biden associates considered several possibilities for the top job, but ultimately failed.
In recent weeks, research has languished as officials decided the refusal to make Woodcock the permanent commissioner was too strong. She was the subject of critical votes like Senator Joe Manchin, a moderate Democrat from West Virginia, for the generosity with which the FDA approved opioids when she headed the drug division within the agency. Manchin’s condition has been ravaged by opioid addiction.
Two officials said it could be “weeks” for Biden to settle down on anyone.
The search has been wide-ranging, with officials inside the West Wing and outside advisers to Biden all looking for possible candidates. They have sometimes considered the acting commissioner, former Obama officials and outside public health experts. At one point, an outside adviser even contacted Dr Stephen Hahn, the commissioner of the FDA under former President Donald Trump, to gauge his opinion on the outlook.
“We’re working really hard on this to make sure we can get it through,” Biden said Tuesday when asked why no permanent director has been appointed yet.
White House press secretary Jen Psaki said Wednesday that research remains a “priority,” but Biden is waiting to find “exactly the right person.”
“He wants to appoint someone who is qualified, who is ready to lead the FDA. It is a priority for him. Nor will he take a step to nominate a candidate until he has found exactly the right person,” Psaki said.
She added, “I will note that this is a place that is filled with talented, experienced scientists, data experts, who certainly run the FDA effectively.”
At the heart of the research is the selection of a candidate who is not only qualified for the specific skills associated with the post of commissioner of the FDA, but who can also obtain enough approval to be confirmed, a task that has proven to be more difficult than expected for the White House.
Pressure to appoint a permanent commissioner has only increased as the FDA nears formal approval of the Pfizer-BioNTech coronavirus vaccine, which officials say could occur in the coming weeks.
“God willing, the FDA is going to come out within a reasonable time to say this vaccine is completely safe,” Biden said Tuesday.
Agency officials say teams are working as quickly as possible to get the vaccine approved in record time. While Pfizer-BioNTech began submitting data for the review process in April, it operated continuously until mid-July.
The agency has recruited additional “sprint teams” that focus on one project at a time, as opposed to multiple projects that people at the FDA are usually working on at the same time. Experts who come from all FDA offices help support the biologics makers who will make the decision to grant approval. These officials worked endless hours, including weekends, as they pored over the data. The effort involves hundreds of FDA employees, according to an FDA official.
“We took a holistic approach, including identifying additional resources such as agency-wide staff and technology resources and opportunities to re-prioritize other activities, in order to complete our review for help combat this pandemic outbreak, ”an FDA spokesperson told CNN Wednesday. “In this regard, Dr. Woodcock reiterated his appreciation for the diligence and integrity of this process and offered all agency resources to the team to make this happen. “
Applications require careful examination of millions of pages of documents. In addition to reviewing company data, the FDA performs its own analysis to verify numbers and approve manufacturing procedures, and then conducts a secondary and tertiary review.
“Once you’ve approved a drug, that’s it,” a health official told CNN. “It’s the ball game.”
The FDA commissioner does not make the final decision to grant approval to a vaccine. While the commissioner oversees the agency, vaccine approval authority has been delegated for years.
The decision to approve the Covid-19 vaccine will be made by the Center for Biologics Evaluation and Research Office for Vaccines Research and Review, as well as the Bureau of Biostatistics, the Office of Compliance and others.
However, Woodcock – while acting – made it clear in internal conversations that this was a top priority, according to an administration official.
“The role of the FDA commissioner is of critical importance, especially during the Covid-19 pandemic,” a White House spokesperson said. “We have strong interim leadership in place that plays an important role in our response to Covid-19 and beyond, and we look forward to sharing a candidate with the expertise and leadership required for this position. “
Woodcock has long been a respected leader among many within the agency, and even as an interim commissioner, she still has all the strength and power to guide the agency, said George Karavetsos, who had served as Director of the FDA’s Bureau of Criminal Investigations and now provides strategic advice to FDA regulated companies.
Having been sent to the White House to work on Covid-19 vaccines as part of Operation Warp Speed and having also served as director of the Center for Drug Research and Evaluation, Woodcock is uniquely qualified to lead the vaccine issue. , did he declare.
“I don’t see anyone who would be better positioned to spearhead the vaccine,” Karavetsos said. “There was no slacking off on the gas with her as an actor.”