Dec. 20, 2021 — Dr. Robert Califf, President Joe Biden’s nominee for the FDA Commissioner position, spent roughly two hours answering questions volleyed his way during last week’s Senate Health, Education, Labor, and Pensions (HELP) Committee’s hearing on his nomination.

Califf’s answers, peppered with details, facts and figures, references to senators’ home-state concerns, anecdotes about his own family’s experiences in the healthcare system and lessons from his career in medical research, left a generally positive impression, according to Coalition for Healthcare Communication Executive Director Jon Bigelow. “It was an impressive performance as [Califf] seeks to return to the position he held in the final year of the Obama administration,” Bigelow said in a Dec. 20 CHC Industry Leaders Alert.

Califf’s top priorities

In his Dec. 14 opening statement, Califf set out three top priorities:

• Improving emergency preparedness and response for situations such as the COVID-19 pandemic—or future emergencies such as the emergence of a multiple-resistant antimicrobial.
• Ensuring that “all FDA actions must focus on protecting consumers and patients; safety matters.” He cited the need to collect data on safety and efficacy in the real world, the need to protect children from tobacco and vaping, and the need to address the epidemic of opioid deaths.
• Leveraging advances in technology, which he believes will allow the FDA to use data in better ways. In particular, Califf said he had spent a lot of his own career looking at how to use data and organize it to make it meaningful.

Other areas where he committed to action included conducting a comprehensive review of the FDA’s policies on opioid approvals and labeling, improving the global supply chain for pharmaceutical ingredients, and addressing health disparities among races and ethnic groups, as well as between rural and urban areas.

Committee challenges emerge

Both HELP committee chair Sen. Patty Murray (D-Wash.) and ranking member Richard Burr (R-N.C.) were complimentary in introducing Califf. Burr praised Califf as “a great doctor, a great man,” and said “I’m not sure you could write a resume of someone more qualified to be considered for Commissioner than Rob Califf.” This is especially significant considering that Burr represents a state where tobacco is a major industry.

“Other senators were, if less effusive, still generally friendly, but in two areas the discussion was heated,” Bigelow stated. He noted that Sen. Bernie Sanders (I-Vt.) began by describing the pharmaceutical industry as “probably the most powerful special interest here in Washington,” criticizing its heavy spending on lobbying, campaign contributions, and product advertising.

Further, Sanders remarked that “nine of the last 10 Commissioners went on to work for pharma” after their FDA tenures and “unfortunately, Dr. Califf, you are not the exception to that rule.” Citing his pharma board roles and stock holdings since leaving the FDA in 2017, Sanders asked Califf how the American public could believe he would stand up against the pharmaceutical industry’s interests and what he would do to lower the cost of prescription drugs.

Sanders repeatedly interrupted as Califf attempted to answer, Bigelow said, but Califf did get to state that he favors allowing Medicare to negotiate with manufacturers on drug prices. In responding to Sen. Bill Cassidy (D-La.), Califf also said that combatting “legal tricks” to reduce competition will be a focus.

Murray and other senators voiced outrage about the FDA’s past approvals of opioid medications and that Califf had not taken more steps to change FDA review policies in this area during his prior tenure.

What happens next?

The HELP Committee still must vote on whether to forward Califf’s nomination to the full Senate, and the final confirmation vote almost certainly will not be held until January. “While most senators have not yet announced their positions, the tenor of this hearing suggests that Califf will be confirmed, putting him on track to be sworn in just before the first anniversary of the Biden administration,” said Bigelow.

To learn more about Califf, his priorities and the challenges facing the FDA, register for a Jan. 12, 2022, CHC Webinar featuring Nancy Bradish Myers, president of Catalyst Healthcare Consulting. Myers is a former Special Assistant and Senior Strategic Advisor to the FDA Commissioner, and former senior official at PhRMA and at BIO. Don’t miss this inside look from someone who knows the agency and the players! Click here for more information and to register.