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Califf on Path to Win FDA Chief Role Despite Expected ‘No’ Votes

Jan. 24, 2022, 6:37 PM

Robert Califf’s previous stint as FDA chief will help him secure the role once again despite growing lawmaker opposition over his drug industry ties, former agency officials say.

At least five Democratic senators have said they would oppose Califf as he awaits a full Senate vote, and it’s unlikely that he will see the same level of overwhelming support he got in 2016. But policy analysts say his record of letting science guide agency decisions will outweigh concerns over how Califf might act on opioids or the abortion drug mifepristone.

“He is a well-respected leader,” former FDA Deputy Chief of Staff Kalah Auchincloss said. “He’s got excellent ideas on clinical trial reform and real world evidence, and he’s proven himself in the past at his prior tenure at FDA to be a great commissioner.”

Califf would return to the agency as it grapples with concerns over its independence and credibility, which lawmakers have called into question amid the Covid-19 pandemic. Analysts say he’s poised to bring steady leadership and clear direction.

Several Democrats, however, have said they aren’t convinced Califf would take steps to strengthen opioid safety regulations amid an addiction crisis that’s gotten worse over the pandemic. Meanwhile, the Susan B. Anthony List and other anti-abortion groups have urged lawmakers to vote against Califf over potential FDA actions to remove access barriers to mifepristone, a pill to end early pregnancies.

Sen. Jeanne Shaheen (D-N.H.), who voted for Califf in 2016, told Bloomberg Law last week she would support him once again after Califf assuaged some of her concerns over opioids.

“I had a chance to question him about some of the issues that have been raised with respect to his nomination,” she said. “He is very committed to trying to address the opioid epidemic” and is “interested in having the science dictate the policy.”

The Senate Health, Education, Labor, and Pensions Committee advanced Califf’s nomination Jan. 13 in a 13-8 vote. A full Senate vote has yet to be scheduled.

Califf’s first appointment to lead the FDA was approved in an 89-4 vote.

Current Standing

Califf, a cardiologist and clinical trial researcher, saw bipartisan support from the HELP committee at the Jan. 13 vote. He’s on track “to be confirmed as the next FDA commissioner,” even though he will likely “receive a fair number of no votes from both Democrats and Republicans in the Senate,” said Chad Landmon, a partner at Axinn Veltrop & Harkrider LLP.

“He’s a good, viable candidate, despite some of his industry ties, which actually can be valuable,” said Auchincloss, who’s now an executive vice president at regulatory consulting firm Greenleaf Health.

Sens. Bernie Sanders (I-Vt.) and Maggie Hassan (D-N.H.) were the only members on the Democratic side to oppose Califf in the HELP committee vote. Sens. Richard Burr (N.C.), ranking member of the HELP committee, Susan Collins (Maine), Lisa Murkowski (Alaska), and Mitt Romney (Utah), voted for the nominee on the Republican side.

Some senators in opposition to Califf say his industry connections could get in the way of the FDA’s ability to implement stricter regulations around opioids. But “it’s important to understand how the industry works when you are going to be leading a public health agency that’s regulating that industry,” Auchincloss said.

“As long as you don’t let those particular ties unduly influence you— which, I know Dr. Califf, and he would not do that— I think it’s a benefit to have some expertise and have some knowledge of how companies work,” she said.

Opioid Concerns

Sen. Ed Markey (D-Mass.) is one of several Democrats who have expressed concerns over Califf’s nomination and the FDA’s role in addressing the opioid crisis. The FDA has faced repeated criticism over its prior approvals of Purdue’s OxyContin and other addictive drugs without requiring more thorough warning labels to help combat misuse.

“Dr. Califf did not commit to the decisive and comprehensive action necessary to ensure reforms that the FDA, under his leadership, would implement on opioid regulation,” when they met in December 2020, Markey said in a Jan. 13 letter to acting Commissioner Janet Woodcock.

Hassan said Jan. 11 that she didn’t believe Califf fit the bill of “a strong FDA Commissioner” who “recognizes the role that the agency’s decisions played in fueling” the nation’s opioid epidemic. Sens. Joe Manchin (D-W.Va.) and Richard Blumenthal (D-Conn.) have previously said they wouldn’t support Califf due to his extensive work with the drug industry.

Other Democrats, however, say they are convinced Califf will take a firm stance on improving opioid regulations.

Sen. Patty Murray (D-Wash.), chair of the HELP committee, said at Califf’s December nomination hearing that the opioid crisis is among the challenges the nominee is capable of tackling after working on it during his previous tenure. Murray added that she looks “forward to working with” Califf “to ensure FDA continues to protect families across the country, uphold the gold standard of safety and effectiveness, and put science and data first.”

Califf said during the December hearing that if he’s confirmed, he will lead an extensive review of opioid regulations, including looking at the FDA’s labeling process and whether warnings accurately describe the safety risks associated with the addictive drugs.

Abortion Pill Access

The FDA’s move to loosen restrictions around abortion-inducing drug mifepristone is another sticking point in Califf’s nomination.

Dominique McKay, a spokeswoman for Sen. Tim Scott (R-S.C.), said “there were concerns regarding actions taken at the FDA during Dr. Califf’s tenure on this issue and that is why the senator ultimately voted no.” Scott, along with Sens. Bill Cassidy (R-La.) and Jerry Moran (R-Kan.), voted against Califf’s nomination Jan. 13, despite voting for him in 2016.

The FDA in March 2016 relaxed certain guidelines for taking mifepristone, including reducing the dosage from 600 milligrams to 200 milligrams and extending the window in which pregnant individuals can take the drug. The agency went further in December by permanently removing a requirement that patients physically visit a medical provider to access the drug.

Califf said at his December hearing that he wasn’t involved in the agency’s most recent internal discussions on mifepristone, but added that he trusted “FDA staff to make good decisions” that are “based on the latest data and scientific principles.”

Despite some Republican opposition, Burr has urged his GOP colleagues to back Califf, arguing that his research experience and previous time leading the agency gave him a “unique perspective” that would be beneficial in leading the agency as the country continues to fight the Covid-19 pandemic.

As to whether the FDA under Califf will further relax restrictions on mifepristone, Auchincloss said she believes Califf will “follow the science and the public health experts on their recommendations for next steps.”

To contact the reporters on this story: Celine Castronuovo at ccastronuovo@bloombergindustry.com; Alex Ruoff in Washington at aruoff@bgov.com

To contact the editor responsible for this story: Alexis Kramer at akramer@bloomberglaw.com

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