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Senate Republicans Play Wait and See With Biden’s New FDA Pick

Nov. 17, 2021, 4:07 PM

President Joe Biden will need the support of Senate Republicans to confirm his pick to lead the FDA but, so far, the White House has done little to convince them, senators say.

Republicans on the Senate health panel that will first consider Robert Califf, Biden’s choice to lead the Food and Drug Administration, said this week they’ve gotten no official information on his nomination.

That lack of material means they’re hesitant to endorse the pick, even though many of them supported him for the same position five years ago. Califf served as FDA commissioner from 2016-17 in the Obama administration.

“He’s been out of government for a long time and the FDA has gone through a lot since then,” Sen. Richard Burr (R-N.C.), ranking member of the Committee on Health, Education, Labor and Pensions, said. “I want to make sure my members get the full opportunity to review everything first.”

Sen. Patty Murray (D-Wash.), the committee chair, said Califf’s nomination paperwork hasn’t been submitted to the panel, so a nomination hearing hasn’t been scheduled.

Califf’s nomination needs the support of Republicans like Burr because at least two Senate Democrats have already come out against him. Sens. Joe Manchin (D-W.Va.) and Richard Blumenthal (D-Conn.) have both said they oppose his nomination due to his ties to the pharmaceutical industry and concerns around whether he’s done enough to deal with the ongoing overdose crisis in the U.S.

Senate Republicans, though, say they want assurances from Califf that the FDA will learn some lessons from the Covid-19 pandemic.

A spokesperson for the White House said it looks forward to working with the Senate to confirm him quickly.

Califf didn’t immediately respond to a request for comment. The FDA referred a request for comment to the White House.

Senator Wish List

Burr has been an outspoken supporter of making changes to the FDA to help accelerate development of medical countermeasures and vaccines.

Sen. Roger Marshall (R-Kansas) said Tuesday he wants the agency to allow doctors to get better information about off-label uses for medications. Marshall has been a supporter of using the anti-malarial drug hydroxychloroquine to combat Covid-19 infections, and he said the FDA didn’t do enough to look into its effectiveness.

“They simply didn’t pay enough attention to some of these antiviral medications as well as generic medications that can be used for Covid,” Marshall said.

The FDA revoked the emergency use authorization on hydroxychloroquine after clinical trials showed the anti-malarial drug wasn’t effective against Covid-19 and that there were risks of “ongoing serious cardiac adverse events.”

Some policy analysts say Califf’s nomination is intended to represent a reclamation of the agency’s reputation, tarnished by alleged political meddling during the pandemic.

The nomination suggests that “the first priority for the FDA now is to get its very-battered reputation back on track,” said Yaniv Heled, a Georgia State law professor focusing on biomedical technologies.

Nearly a year into the Biden administration there’s pressure to get a permanent FDA commissioner in place, and Califf has the experience of being confirmed before, said Kalah Auchincloss, who served as Califf’s deputy chief of staff at the FDA.

“There’s no question that he has impeccable credentials and is well qualified to do this job,” she said. “In my mind, it’s hard to find an objection that you can really put up.”

Former FDA officials say that Califf would bring steady leadership to the agency and play an important role in boosting drug competition and patient access to innovative treatments. Califf’s first appointment to lead the FDA was approved in an 89-4 vote in 2016.

Califf, though, has “very little public health and infectious disease experience,” said Georgetown professor of global health law Lawrence Gostin. “Right now, we’re in a pandemic, and the FDA’s main job is to help us out of this pandemic, and he doesn’t really have any experience in the CDC, state and local public health agencies, or infectious diseases.”

The pandemic is “going to be front and center his entire term,” he said.

‘Big Question Marks’

Pre-pandemic, the FDA had a “really great reputation” under commissioner Scott Gottlieb, a Trump appointee seen as acting in the interest of the agency over outside interests, Heled said.

Fast-forward to the Covid-19 era, where the FDA “veered strongly off-course in various junctures,” Heled said. Among the Trump FDA’s questionable calls were emergency-use authorization for chloroquine, hydroxychloroquine and convalescent plasma for Covid-19 treatments, he said.

“What we do know is, one day President Trump says that chloroquine and hydroxychloroquine are wonder drugs against Covid-19. There’s absolutely no data out there to support that,” Heled said.

Meanwhile, under Biden, the FDA’s controversial approval of the Alzheimer drug Aduhelm proved “a huge black eye for the institution,” he said. The FDA accelerated approval of the drug despite clinical trials providing different results on the drug’s efficacy.

“These were big question marks on the agency’s adherence to scientific rigor,” Heled said.

There also remains a “question mark” around Califf’s own record, Heled said. That’s the FDA approval, under his watch, of a Sarepta Therapeutics drug for Duchenne, a disorder involving muscle degeneration, a move that went against the advice of an FDA advisory panel.

The next FDA commissioner “has to fiercely defend the independence of the agency against political and corporate influence,” Gostin said, which could prove problematic for Califf, who “has deep relationships with the pharmaceutical industry, including companies that are heavily regulated during the pandemic,” such as J&J, Merck & Co. Inc., and AstraZeneca plc.

“He’s had a close relationship with industry for a long time, so that is concerning,” Gostin said. But the bigger concern is whether he’ll be “close and cozy” with the “pharmaceutical industry as they’re seeking authorizations and approvals for Covid vaccines and drugs and antivirals.”

—With assistance from Jeannie Baumann

To contact the reporters on this story: Alex Ruoff in Washington at aruoff@bgov.com; Ian Lopez in Washington at ilopez@bloomberglaw.com

To contact the editors responsible for this story: Melissa B. Robinson at mrobinson@bloomberglaw.com; Alexis Kramer at akramer@bloomberglaw.com

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