White House vetting former FDA Commissioner Dr. Rob Califf to once again lead agency

By Kaitlan Collins and Jeremy Diamond, CNN

The White House is in the process of vetting former Food and Drug Administration Commissioner Dr. Rob Califf to become the agency’s leader once again, according to three sources familiar with the process.

For nine months, President Joe Biden has struggled to find a candidate who is both qualified and could win Senate confirmation. The White House ruled out the current acting commissioner, Dr. Janet Woodcock, after it became clear she would face steep opposition from a handful of lawmakers, including West Virginia Democratic Sen. Joe Manchin, for how liberally the FDA approved opioids when she ran the drug division within the agency.

Though Califf is seen as a final contender, a decision has not yet been made and others are also still being considered. Califf did not respond to a request for comment.

“There has not been a decision made for the FDA commissioner and we remain grateful to the strong acting leadership at the FDA,” a White House official told CNN in a statement Thursday.

Woodcock cannot legally stay on as the acting head past November 15 unless a permanent commissioner has been nominated. The White House is expected to name a nominee in the coming weeks.

The Washington Post first reported Califf’s consideration for the role.

When Califf was up for confirmation in 2016, he faced opposition from several Democrats, including Manchin, who criticized his ties to the pharmaceutical industry and argued they must “act now to change the culture at the FDA if we have any hope of stopping the prescription drug abuse epidemic that is ravaging our nation.” Califf was confirmed by a vote of 89-4.

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 backed current acting FDA Commissioner Dr. Janet Woodcock, who went against the FDA’s independent advisory group that recommended against eteplirsen’s approval.

DMD has no cure, and at the time the only other approved treatment was steroids, which had severe side effects. DMD primarily impacts boys and is usually diagnosed by the age of 5. Many with Duchenne rely on wheelchairs as their muscles quickly lose strength and begin to have difficulty breathing around age 20. Ultimately, many die from lung disorders within a few years after that.

At the time, members of the advisory committee disagreed whether the data proved the drug was effective, despite public pleas from families who felt their children had no other options. Dr. Ellis Unger, who was then director of the FDA’s Office of Drug Evaluation, wrote that he was concerned that the drug’s approval would leave the FDA “in the position of having to approve a myriad of ineffective treatments for groups of desperate patients.”

Some experts worried that the approval signaled the agency was too willing to bend to the emotional appeals of patients.

Last month, the White House would not predict what the timeline was for nominating a permanent head.

“The role of the FDA commissioner is critically 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 in place that is playing an important role in our Covid-19 response and beyond, and look forward to sharing a nominee with the required expertise and leadership for this job, so hopefully we have something soon to share.”

The deadline comes as the White House has another key health leadership role to fill, with the decision of Dr. Francis Collins, the National Institutes of Health director, to step down by 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 last 10 months looking at recommendations for the role, including from former FDA commissioners, and even putting some candidates through a vetting process, only to come up short so far.

There has been an emphasis on looking for someone who understands the communication challenges of public health and the agency, rather than just focusing on an academic — prompted by what some see as verbal missteps from Dr. Rochelle Walensky, who helms the US Centers for Disease Control and Prevention.

Complicating matters even more is some recent internal turmoil at the agency.

Last month, two senior leaders in the vaccine review office announced they were stepping down, even as the agency is working toward high-profile decisions around Covid-19 vaccine approvals, authorizations for younger children and booster shots. The retirements of Dr. Marion Gruber, director of the Office of Vaccines Research and Review at FDA’s Center for Biologics Evaluation and Research, and Dr. Philip Krause, deputy director of the office, were announced in an internal agency email.

This story has been updated with background reporting.

The-CNN-Wire
™ & © 2021 Cable News Network, Inc., a WarnerMedia Company. All rights reserved.

CNN’s Kristen Holmes and Nadia Kounang contributed to this report.