Senate health committee again offers its support for FDA commissioner nominee Rob Califf
Rob Califf, the famous cardiologist from Duke University, is likely to return to the top of the FDA, this time under the Biden administration.
At his confirmation hearing Tuesday, Democrats and Republicans on the Senate health committee offered their support for Califf, with Chair Patty Murray (D-WA) stressing the need for an experienced leader, like Califf, who can ensure that science comes first.
“I’m not sure you could write a resume for someone who’s more qualified to be FDA commissioner,” Sen. Richard Burr (R-NC) said while introducing Califf and saying he thought there was enough Republican support to get Califf across the finish line.
While criticizing President Joe Biden for leaving this commissioner position open for almost a year, Burr called on Califf to ensure that FDA does “not go back to the ways before Covid. We need a war time commissioner.”
Califf, who recently worked as a senior adviser to Google Health and Verily, and is well-known for his clinical research knowledge, called the pandemic “devastating,” and said he was ready to “hit the ground running” while thanking acting FDA commissioner Janet Woodcock and the agency’s staffers for their “exemplary service” over the past several years.
“I’m going to be very aggressive in this area of medical misinformation,” Califf said.
He stressed that all of the FDA’s actions must focus on protecting consumers and patients, calling for a more “systematic approach to improve patient safety and better understand benefits and risks” of medical products.
Califf was also questioned repeatedly on real weal world evidence, one of his longtime pet projects. He said the FDA needs to get systems in place to produce real world data more quickly, give people the confidence to share data, and “get those rules right.”
When several Democrats raised concerns with the FDA’s handling of the continued opioid epidemic, Califf committed to conducting a review of opioid labels, adding, “We need to learn from the past several decades and reassess because whatever we’ve done until now is not enough.”
Attracting and retaining the scientific workforce at FDA, meanwhile, “may be more important than any other policy,” Califf said. Two senior vaccine officials recently retired and CBER in particular is struggling to retain and recruit talent.
While Califf has his foes, mostly for his web of financial ties to industry, including Democrats like Joe Manchin (WV), Ed Markey (MA), Richard Blumenthal (CT), Bernie Sanders, and potentially Ben Luján (NM), Republicans who previously supported him in 2016 — Sens. Burr, Bill Cassidy (LA), Susan Collins (ME), and Mitt Romney (UT) — seemed to offer their support again in Tuesday’s hearing.
And should more Democrats defect from voting for Biden’s selection for FDA, a total of 34 Republicans who previously voted to confirm Califf on his first time around are still in the Senate.
“The Covid-19 pandemic has made clearer than ever the choice between pharmaceutical profits and the health of our people. In this critical moment, Dr. Califf is not the leader Americans need at the FDA,” Sanders said in a statement on Tuesday.
In questions from Burr and others on the accelerated approval pathway, which is under scrutiny inside the agency and within HHS, Califf said that he’s “a fan of accelerated approval under the right conditions,” such as for people with rare genetic diseases or life-threatening cancer. But he conceded the US needs a better system to evaluate accelerated approval products as they’re used on the market.
Six former FDA commissioners, as well as more than 90 other organizations offered their support for Califf late Monday, including a letter of support from the National Health Council, which has PhRMA and BIO executives on its board.
Other Republicans questioned Califf over what the FDA might do with the birth control drug mifepristone, as the Biden administration previously signaled that the FDA may remove a decades-old prohibition on dispensing such pills via mail. But Califf said he would listen to the career experts and the latest data.
And while the FDA doesn’t usually dip its toes into areas like drug pricing, Califf said that he’s on record supporting Medicare’s ability to negotiate prices. Sanders also questioned Califf on how to make drugs more affordable and Califf mentioned the need for a more robust generics industry. The biosimilars program needs to do better too, he said.
“Wealthy countries need to pay their fair share,” Califf said. But he noted the US has not a hit a sweet spot, as financial toxicity remains a serious issue for cancer patients. Almost one-quarter of those patients skip their chemo treatments because of the cost, he said.