Former FDA Commissioner Califf: 'This is the time to be intense'

Serving twice as commissioner of the U.S. Food and Drug Administration has made Robert Califf, M.D., pretty much immune to getting tripped up by difficult or controversial questions.

“People should not feel shy about asking me questions,” he said at a recent public seminar held by the North Carolina Regulatory Affairs Forum. “I’ve been through two Senate confirmations. There was a strange love affair between (Senator) Bernie Sanders and the right-wing Republicans about nutrition. So, you know, there’s nothing you could ask that would be offensive.”

Having lived through Washington’s polarizing political climate, Califf spoke openly, sharing his views on current health policy at the seminar, held before a sold-out crowd at the North Carolina Biotechnology Center.

Califf completed his second term as FDA commissioner in January with the change in administrations. He’s only the second person to have served twice in the role – first under President Obama (2016-2017) and again under President Biden (2022-2025).

He has since returned to Duke University as an instructor in the Department of Medicine and to continue his work at the Duke Clinical Research Institute, which he helped found in 1996.

Staying engaged

Califf called on the audience – regulatory affairs professionals in the pharmaceutical and medical device industries – to remain engaged with policy debates that impact public health.

“In areas that you can work on and have influence, I think this is the time to be intense,” he said. “And I’d also say, call your congressperson every day. It has a bigger impact than you might think.”

With mass layoffs of U.S. Department of Health and Human Services staff, challenges to medical research and vaccine efficacy, and other changes in federal health policy, healthcare professionals should begin looking for opportunities to rebuild trust, Califf said.

He noted that our current system of healthcare in the United States has long had its share of problems – a fact that has contributed to distrust in the system and a desire by many to “burn down the structures that currently exist.”

“If things get much more chaotic and difficult, at some point people are going to want it to be put back together again. So I think a lot of you are wondering what to do. You need to be thinking about what should be different if you do have a chance to put the system back together in a different way.”

Califf said he wouldn’t comment on the work of his successor, Marty Makary, MD, MPH, given how new he is in the role. But he questioned some of the priorities of HHS Secretary Robert F. Kennedy Jr., saying Kennedy is taking aim at the pharmaceutical industry out of a mistaken belief that it’s colluding with the FDA to harm the public.

For example, Califf referred to a recent meeting he had with families and advocates for people with rare diseases. He said their hope for breakthroughs in gene editing, which could help treat or even cure patients with previously incurable conditions, is turning to fear.

Looking at value

During his talk, in a question-and-answer format with Maria Oyaski, current president of the NCRAF, Califf touched on a variety of issues that affect regulatory affairs.

He noted that in the U.S. regulatory system, the FDA’s charter is to evaluate the safety and efficacy of proposed medications and devices. Yet the No. 1 issue for most people – the cost of drugs – is largely outside the agency’s purview. Califf said there should be a way for regulators to examine the value of potential drugs before they’re approved.

Better use of data, including artificial intelligence tools, could help on both sides of the value equation: Higher success rates for the pharma and device companies investing large sums of money to bring products to market, and more affordable prices for the consumers who need the products.

“I’m a free citizen now for over 100 days, and I’ve talked to a lot of people,” said Califf, who worked for Google parent Alphabet Inc. between his stints as FDA commissioner. “Right now, we’ve got a health system that’s completely financially driven.

“So, who’s going to institute the standards by which you might assess whether the benefits outweigh the risks for an AI? This is a place where I think it’s going to be really important for FDA to be a part of.”