White House revises former FDA commissioner Dr. Rob Calif to head agency once again

For nine months, President Joe Biden has struggled to find a candidate who is qualified and can win Senate confirmation. The White House dismissed the current acting commissioner, Dr. Janet Woodcock, after it became clear that she would face strong opposition from a handful of lawmakers, including West Virginia Democratic Sen. Joe Manchin, because of how liberally the FDA had approved opioids. Approved when he ran it. Drug Division within the agency.

Although Calif is being seen as the final contender, no decision has been taken yet and others are being considered. Calif did not respond to a request for comment.

“No decision has been made for the FDA commissioner and we are grateful to the strong acting leadership at the FDA,” a White House official said in a statement to CNN Thursday.

Woodcock cannot legally continue as acting chief before 15 November unless a permanent commissioner has been nominated. The White House is expected to name a nominee in the coming weeks.

Washington Post First reported Calif’s idea for the role.

When Calif was up for confirmation in 2016, it faced opposition from several Democrats, including Manchin, who criticized its ties to the pharmaceutical industry and argued that if we had any hope of stopping prescriptions, they would have to “get the FDA”. We must act now to change the culture of the drug abuse epidemic that is ravaging our country.” Calif was confirmed by a vote of 89–4.

As head of the FDA, Calif oversaw the controversial 2016 approval of atplirsen, a drug used to treat Duchenne muscular dystrophy (DMD), a rare form of the genetic disorder. In reviewing the decision, Calif supported the current Acting FDA Commissioner, Dr. Janet Woodcock, who went against the FDA’s independent advisory group, which recommended against approval of etaplirsen.

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

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

Some experts were concerned that the approval indicated the agency was willing to bow to the emotional appeals of patients.

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

“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 that is playing a vital role in our Covid-19 response and beyond, and look forward to sharing a nominee with the expertise and leadership needed for this job, so hopefully We have something to share soon.”

The deadline comes as the White House takes on a more important role of health leadership, which National Institutes of Health Director Dr. With the decision of Francis Collins, the decision is made 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 the past 10 months looking at recommendations for the role, including those of former FDA commissioners, and even putting some candidates through a vetting process. has been kept from, only yet to come.

Rather than focusing on just one academic, the emphasis is on seeking someone who understands the communication challenges of public health and agency – which some see as the verbal missteps of Dr. Rochelle Valensky, the US Centers for Hell Disease Control and Prevention.

To complicate matters even more, the agency has had some internal turmoil lately.

Last month, two senior leaders in the Vaccine Review Office announced they were stepping down, even as the agency directed high-profile decisions around Covid-19 vaccine approval, authorization for young children, and booster shots. working in The retirements of Dr. Marion Gruber, director of the Office of Vaccine Research and Review at the FDA’s Center for Biologics Evaluation and Research, and Dr. Philip Krauss, deputy director of the office, were announced in an internal agency email.

This story has been updated with background reporting.

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


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