Califf Sails Through Senate Confirmation Hearing
President Biden’s pick to become FDA commissioner, Robert Califf, received bipartisan support last week during a two-hour Senate confirmation hearing that touched on innovation, real-world evidence (RWE) and the cost of clinical trials.
Califf, who was FDA commissioner from 2016 to 2017, hasn’t been shy to point out the alarming bulkiness clinical trials have packed on through the years as trial cost, duration and complexity continue to increase, leading to greater burdens and pitfalls for sites and calls for action to reverse those issues.
During the Senate Health, Education, Labor and Pensions Committee (HELP) hearing, Califf also faced questions on negotiated drug prices — which he supported, provided they do not “squelch” innovation — the agency’s perceived missteps in the opioid epidemic and what reforms he might make to the FDA’s accelerated approval pathway.
The Senate HELP committee has not set a date to vote on Califf’s nomination, a required step before the full chamber considers his nomination.
For RWE, Califf stressed the importance of developing a system that Americans trust to use their electronic health records (EHRs), calling a better evidence generation system essential to balancing innovation with patient safety.
Responding to questioning by Sen. Bill Cassidy (R-La.) about using RWE to arrive at quicker answers for drugs, especially those under the accelerated approval pathway, Califf said he believes that while the agency is “well down the road now in having a functional system … I also want to assure people I’m not talking about willy nilly analysis of data.”
Califf’s debut hearing as Biden’s nominee for commissioner appeared to go smoothly in the evenly divided Senate, though he was grilled harshly by both Sens. Maggie Hassan (D-N.H.) and Ben Ray Luján (D-N.M.) on the FDA’s role in the opioid crisis. Sen. Bernie Sanders (I-Vt.) also criticized Califf for his ties to the pharmaceutical industry.
While Hassan looks to be on the fence in voting for his nomination, Sens. Richard Blumenthal (D-Conn.), Joe Manchin (D-W.V.) and Ed Markey (D-Mass.) at the least will likely vote against him, and Califf is likely to need Republican support to get the job.
Adding to the chorus of support was a letter to the HELP committee sent last week by six former FDA commissioners — Andrew von Eschenbach, Scott Gottlieb, Stephen Hahn, Margaret Hamburg, Jane Henney and Mark McClellan — who said Califf “has the experience to be effective from Day One, having previously served as commissioner with strong bipartisan support.”
Read the letter from the former FDA commissioners here: https://bit.ly/3suFgFJ.