For nine months, President Joe Biden has struggled to find a candidate who is qualified and who can get Senate confirmation. The White House ruled out incumbent Commissioner Janet Woodcock after it became clear she would face strong opposition from a handful of lawmakers, including West Virginia Democratic Sen. Joe Manchin, for freedom. that the FDA approved opioids when leading the drug division within the agency.
Although Califf is seen as a final candidate, no decision has yet been made and others are also being considered. Califf did not respond to any requests for comment.
“No decision has been made for the FDA commissioner and we remain grateful for the strong leadership of the FDA acting,” a White House official told CNN on Thursday.
Woodcock cannot legally remain in office on November 15 unless a permanent commissioner has been appointed. The White House is expected to nominate a candidate in the coming weeks.
As head of the FDA, Califf oversaw the controversial 2016 approval of eteplirsen, a drug used to treat Duchenne muscular dystrophy (DMD), a rare form of the genetic disorder. In a review of the decision, Califf supported the current FDA acting commissioner, Dr. Janet Woodcock, who opposed the FDA’s independent advisory group that recommended the approval of eteplirsen.
DMD has no cure and at that time the only other treatment approved was steroids, which had serious side effects. DMD mainly affects children and is usually diagnosed at 5 years of age. Many Duchennes rely on wheelchairs as their muscles lose quite quickly and begin to have difficulty breathing around the age of 20. Ultimately, many die from lung disorders a few years later.
At the time, members of the advisory committee disagreed on whether the data showed the drug was effective, despite public requests from families who felt their children had no other options. Dr. Ellis Unger, then director of the FDA’s Office of Drug Evaluation, wrote that he was concerned that drug approval would leave the FDA “in the position of having to approve a myriad of treatments. ineffective for desperate patient groups “.
Some experts worried that the approval would indicate that the agency was too willing to bow to patients ’emotional appeals.
Last month, the White House would not predict what the timetable was for the appointment of a permanent head.
“The role of the FDA commissioner is very important, as you all know, especially during the Covid-19 pandemic,” White House deputy press secretary Karine Jean-Pierre told reporters. “We have strong acting leadership that plays an important role in our response to Covid-19 and beyond, and we look forward to sharing a candidate with the experience and leadership needed for this job, so we hope we have something soon to to share”.
The deadline comes when the White House has another key health leadership role to play, with the decision of Dr. Francis Collins, director of the National Institutes of Health, to step down at the end of the year. Collins has led the agency for more than a decade.
Sources close to the FDA nomination process said the administration has spent time over the past ten months examining recommendations for the role, including former FDA commissioners, and even getting some candidates to go through a verification process, up to short so far.
Emphasis has been placed on finding someone who understands the communication challenges of public health and agency, rather than focusing only on one academic, motivated by what some see as verbal steps by Dr. Rochelle Walensky, who heads the Centers of the United States. Disease control and prevention.
Complicating matters further is a recent internal agitation of the agency.
Last month, two leaders in the vaccine review office announced their cessation, although the agency is working to make high-profile decisions on approvals of the Covid-19 vaccine, authorizations for younger children. and booster vaccines. The retirements of Dr. Marion Gruber, director of the Office of Vaccine Research and Review at the FDA’s Center for Biological Assessment and Research, and Dr. Philip Krause, deputy director of the office, were announced in an email from the internal agency.
This story has been updated with background reports.
CNN’s Kristen Holmes and Nadia Kounang contributed to this report.
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