Dems grill Biden FDA nominee over opioids, pharma ties

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Sen. Bernie Sanders grills FDA nominee Robert Califf over ties to pharmaceutical industry

FDA Commissioner nominee Robert Califf sits for confirmation hearing before Senate HELP Committee

President Biden’s nominee to be the next commissioner of the Food and Drug Administration, Robert Califf, faced a wide range of questions during his confirmation hearing Tuesday, but some of the toughest grilling came from Democrats, making his future far from a certainty.

Califf served as FDA commissioner during the end of the Obama administration from February 2016 to January 2017, and it was this history that was the basis for some of the more pressing queries. Sen. Bernie Sanders, I-Vt., noted that several former commissioners went on to accept jobs with large pharmaceutical companies, and that Califf is among them.

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"One of the major reasons the pharmaceutical industry, among many others, is so powerful is its close relationship with the FDA and other regulators in Washington," Sanders said, adding that nine out of the last 10 FDA commissioners went on to jobs or board positions at pharmaceutical companies.

Robert Califf testifies before a Senate Committee on Health, Education, Labor and Pension hearing on the nomination to be commissioner of Food and Drug Administration on Capitol Hill in Washington, Tuesday, Dec. 14, 2021. (AP Photo/Manuel Balce Ceneta)

"Unfortunately, Dr. Califf, you are not the exception to that rule," Sanders said, pointing to how Califf has made hundreds of thousands of dollars from pharmaceutical companies, including consulting fees from several of them, and that he currently owns as much as $8 million worth of pharmaceutical stock.

"At a time when the American people are outraged by the high cost of prescription drugs … what kind of comfort can you give to the American people when you have been so closely tied to the pharmaceutical industry yourself?" Sanders asked.

"I do appreciate your concern," Califf said, adding that he agrees that drug prices are "too high in this country." 

"With regard to my own status," he continued, "I am a physician first and foremost." 

He later stated that the Biden administration has "the most stringent ethics pledge in the history of administrations" and they have reviewed his status.

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Sen. Maggie Hassan, D-N.H., grilled Califf over pharmaceuticals, specifically FDA-approved opioid like oxycontin.

Senate Committee on Health, Education, Labor and Pension member Sen. Bernie Sanders, I-Vt., questions Robert Califf during a hearing on the nomination of Califf to be Commissioner of Food and Drug Administration on Capitol Hill in Washington, Tuesday, Dec. 14, 2021.  (AP Photo/Manuel Balce Ceneta)

Califf agreed that the approval process for oxycontin "could have been done differently." 

"Why didn’t you take action to change the oxycontin label when you led the FDA in 2016?" Hassan asked.

Califf did not give an answer, but he stated that he supported "long-term studies" and changes for how opioids are evaluated.

Hassan referred back to anecdote Califf told early in the hearing, about a family member receiving a 30-day prescription for oxycontin that concerned him.

"If the label were different, the doctor wouldn’t have prescribed that family member a 30-day prescription," Hassan said.

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The senator asserted that the government should "aggressively be pursuing relabeling."

"The evidence has been here for a long time," she continued. "It’s the evidence of thousands of people, hundreds of thousands of people dying in this country. It’s the evidence that I see when I go to the funeral of a constituent who has been in recovery multiple times and has relapsed."

Sen. Mitt Romney, R-Utah left, and Sen. Tommy Tuberville, R-Ala., listen to Robert Califf testify before the Senate Committee on Health, Education, Labor and Pension hearing on the nomination of Califf to be commissioner of Food and Drug Administration on Capitol Hill in Washington, Tuesday, Dec. 14, 2021.  (AP Photo/Manuel Balce Ceneta)

Hassan said it is up to FDA leadership to take action.

"There is plenty of evidence about what we need to do about this epidemic and the FDA needs to take the lead," she said.

Hassan was not the only Democrat to bring up opioids. Sen. Ben Ray Lujan, D-N.M., went on a tirade about how the government is approaching the issue all wrong.

Lujan said the U.S. has seen a record number of opioid deaths in the past 12 months.

"The FDA has a long track record of approving dangerous opioid without considering public health," he said. 

Like Hassan, Lujan also asked Califf if he would review labels. Califf said he was "committed to do a comprehensive review" that included labels.

Lujan went on to discuss the advisory committee the FDA refers to, and how that committee voted 11-2 against approving a hydrocodone-based drug, only for the FDA to approve it anyway.

Califf said this "was not the right decision," but that it would have been different had there been more information available at the time.

The Democratic senator then railed against the FDA's overall approach to opioids.

"I'm sick and tired of the United States approving one opioid to fix another. It's the dumbest thing that I've – I just don't understand it. It's stupid! People are dying because of it," he said, noting that heroin was created in a lab, not the street.

"And here in the United States we keep approving one after another."

Califf said he did no dispute Lujan's point, but noted that "there are almost no opioid coming through the FDA now for approval."

"It's really been shut down," he continued, "and I think the roles that I played were critical in doing that."

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Sen. Joe Manchin, D-W.Va., who is not on the committee, also referenced opioid in explaining why he does not plan on voting to confirm Califf. 

"Why we would confirm someone whose actions failed to swiftly curb the tide of the opioid epidemic?" Manchin questioned. "During Dr. Califf's previous tenure as FDA commissioner, drug-related overdoses went up. Five years later, they are up again, this time at a record number."