WASHINGTON — Robert Califf escaped largely unscathed from a two-hour hearing Tuesday vetting him to be commissioner of the Food and Drug Administration. He gushed about his love of high-quality data, skillfully navigated questions on hot-button topics like abortion and drug pricing, and even had personal anecdotes about Covid-19 testing and opioid prescribing at the ready.
His only stumble came when he clearly frustrated lawmakers with his responses to pointed questions about the FDA’s approach toward approving opioid drugs, including its general reluctance to crack down on long-term prescribing of opioids and its recent decisions to approve new high-dose opioids.
‘This is stupid, people are dying because of it,’ Sen. Ben Ray Luján (D-N.M.) said. ‘We keep approving one after another.’
advertisement Califf insisted he had taken the opioid issue seriously during his first term at the agency but that the FDA needed clear evidence to limit the marketing and prescribing of opioids for long-term use — a response that prompted Sen. Maggie Hassan of New Hampshire to say that the evidence ‘has been here for a long time,’ in the form of mounting opioid overdose deaths. ‘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. It’s the evidence that I see when I go to the funeral for that constituent’s sister and listen to the mother who has lost two adult daughters to this illness, despite their repeated attempts to enter into recovery. There is plenty of evidence about what we need to do about this epidemic, and the FDA needs to take the lead,’ Hassan said.
advertisement In the end, Califf promised a ‘very aggressive approach’ toward opioids, including a ‘comprehensive review of the status of opioids’ in the first months of his tenure.
‘I can’t argue with your points,’ Califf told Luján.
The other major hiccup of the high-profile hearing?
Lawmakers couldn’t remember how to pronounce Califf’s name.
Sen. Mike Braun (R-Ind.) called him ‘Dr. Cahill.’ Sen. Tina Smith (D-Minn.) went with ‘Dr. Cardiff.’ And Sen. Jackie Rosen (D-Nev.) settled on a long ‘e’ sound at the end, calling him something along the lines of ‘Dr. Caleef.’
Still, by the end of the hearing even the committee’s top Republican, Sen. Richard Burr of North Carolina, a frequent critic of the FDA, urged his colleagues to support Califf’s nomination.
‘I’m not sure you could write a resume of somebody more qualified to be considered for commissioner of the FDA,’ Burr said. The smooth hearing is the latest signal that Califf, who already survived a confirmation process for the FDA’s top job in 2016, will be easily approved for the job again. A vote on his confirmation has not been scheduled, but is expected in early 2022.
Califf also pledged to crack down on so-called synthetic nicotine products, which e-cigarette companies are selling to avoid FDA regulation.
‘We’ve got to close this loophole,’ Califf said, regarding synthetic nicotine.
The coronavirus pandemic loomed large over Tuesday’s hearing. Califf pegged responding to the pandemic and preparing for future outbreaks as his top priority, should he be confirmed as commissioner.
Senators were particularly concerned about the FDA’s approach toward approving coronavirus tests, which has been criticized for being slow and overly cautious. Califf jovially agreed to review the FDA’s current process for their authorization.
‘I would very much look forward to working with you on that and actually get back to where I started my career,’ Califf said, noting his first job in medicine had him reviewing cardiovascular tests. ‘I’d find it, in a nerdy sort of way, pretty exciting.’
Califf was also more forthcoming during Tuesday’s hearing about his views on drug pricing than he was during his first confirmation hearing in 2015. While Califf bristled in 2015 when Sen. Bernie Sanders (I-Vt.) pushed to get him on the record about his views on letting Medicare negotiate over drug prices, this time he was definitive: ‘I’m on record of being in favor of Medicare negotiating with the industry on prices,’ Califf told Sanders.
But some things never change: Califf also made clear he still was as passionate as ever about helping the FDA and the industry develop better evidence to support regulatory decisions — a topic he called his ‘real professional love’ in 2015. All told, Califf mentioned the word evidence more than a dozen times during Tuesday’s hearing.
At one point he openly encouraged one senator, Roger Marshall (R-Kan.), to ‘dream a little bit’ about setting up an evidence-generation system that would let regulators track the medical conditions of Americans and the medications they’re receiving, with the goal of collecting real-world data on various treatments.
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