Califf wants to create incentives for FDA commissioners to stay longer

High commissioner turnover and difficulty attracting young leaders are undermining staff stability and confidence at the US Food and Drug Administration, Commissioner Robert Califf told a Senate subcommittee hearing on the agency’s FY 2023 budget.

The Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies met on 28 April to talk about the FDA’s proposed FY 2023 budget. But instead of talking directly about what was in the budget request, much of the conversation between lawmakers and Califf addressed issues such as staffing, IT modernization and plans to transition products with emergency use authorization (EUA) to regular marketing approval (Related: FDA seeks $8.4B in FY2023 to modernize regulatory infrastructure, prep for future pandemics, 28 March, 2022, Regulatory Focus).

At the start of the hearing, Califf, who is serving as commissioner for a second time after having served briefly in 2016, noted the FDA has had 7 commissioners in the last decade.

“That's very destabilizing for any place that you are working if the bosses are changing at such a high frequency,” he said.

The commissioner said he has some ideas, but doesn’t want to rush into any decisions. Rather he wants to make changes that will have a lasting effect on the next person in his position, so they don’t feel like they need to start from scratch.

"On another day, I hope we will engage in discussions about the job of FDA commissioner,” he told subcommittee members. “There's a reason there's a turnover so great and I think it deserves careful thought by everyone involved about how to make this a job which someone younger than age 70 would want to take.”

Califf noted that all living past commissioners – regardless of which presidential administration they served – have written about the difficulties of the job, but nothing so far has been done to address the problems.

“None of our jobs are easy. This is a particularly tough one,” he said. “I was glad to come back because I've been through it already and I see the chance to do something for the next generations. But for someone in mid-career who you might want in this job, it's really hard to take it the way it is."

Subcommittee Chair Sen. Tammy Baldwin (D-WI) and Ranking Member John Hoeven (R-ND) asked about recent criticism of FDA’s food safety oversight efforts. In response, Califf said the agency was looking at its internal operations to do better while acknowledging it is essential industries regulated by the agency know who is accountable and who they are talking to at the agency.

He also said the FDA is “intensively” looking at issues of how it is organized and hopes to modernize the agency’s IT systems so regulators can do their jobs better.

"I've learned a lot about how computers can improve human efficiency but also make it a lot more fun,” said Califf. “[Modernizing IT systems] would really attract the best people. We've got to have really first-rate technology on that front."

As for taking criticism, Califf said that comes with the territory.

“You're not FDA commissioner if you're not waking up at 5 am every day to a whole list of criticisms. That was true in 2016 and it's true today,” he said. “But one of the things that made me want to come back, and gave me great solace when I got here, is if you look at the center directors at the FDA, they've been there a while, they're very dedicated to their work, they keep coming to work every day despite all the criticism and I know what their capabilities are.”

Sen. Mike Braun (R-IN) asked Califf about a National Academies of Sciences report that called on the FDA to develop new processes for approving opioids and asked whether the agency was implementing any of the recommendations from the report.

In response, Califf said he had read the report and the agency had already issued draft guidance that takes into account the most important recommendation to look beyond just risk-benefit to the patient when making a decision. He said lawmakers will see a list of actions over the next year that will address the opioid crisis that takes into account the academies’ recommendations (Related: Opioid alternatives: FDA offers insights on developing non-addictive drugs for acute pain, 9 February 2022, Regulatory Focus).

"I must say there are a couple of areas where we're probably going to come back to you if there's concurrence within [the Department of Health and Human Services] and say that we need some new legal authorities," Califf said. Specifically, he noted that the FDA currently doesn’t have the authority to require a new drug application to prove superiority to drugs already on the market. But he said that’s an authority the agency needs to address opioids specifically.

During the hearing, Sen. Hoeven also asked about how the FDA can help address supply chain issues by helping increase domestic manufacturing of drugs, biologics and medical devices.

"We've got to have a resilient manufacturing base that Americans have access to,” said Califf. “That doesn't mean everything needs to be made in America because there's value in international trade...but if we get ourselves into a situation where another country could, either due to a natural disaster or intentionally or the way markets work, cut off our supply that's a real problem."

He said the FDA could help incentivize domestic manufacturing by creating prototypes of public-private partnerships similar to Operation Warp Speed – the effort that spurred the rapid development of COVID-19 vaccines and therapeutics. Another area that the agency could help is with advanced manufacturing, where FDA oversight can provide certainty to smaller manufacturers who can be more geographically spread out.

"As I work with you all this time around, I'm much more aware now of the role of FDA and government in places where there's not an incentive for industry to develop things that society needs,” said Califf. “I think what happened with the vaccine is a super example where the investment we made early in getting all members, government and private [industry], to the table made a big difference."

Hoeven said he was also curious why the FDA had not asked for additional funding in its budget request for gene therapy. Califf noted that the agency did receive some funding in the previous year’s budget and expects to get more funding through the new user fee reauthorization.

"But that does not mean we're not going to come back to you later on areas where the user fees aren't going to cover,” he added.

There are other areas, such as antibiotics and regenerative medicine, where there aren’t enough incentives to drive the markets and no one is sure how such products are going to be paid for. "We'll be back in touch to talk about that I'm sure," he added.

Hoeven also asked Califf how the FDA plans to phase out the EUAs it has authorized during the pandemic.

On the drug side, Califf said the transition issue is much easier as the same studies used for the EUAs have continued with modifications and are producing the data needed for standard approval.

“I think we feel on the drug side that we're in pretty good shape over time to phase out the EUAs and phase in a standard approval that a company can use,” he said.

On the device side, the agency has a definite plan in place that would involve requiring notifications and transition phases once the public health emergency is lifted, he noted (Related: Stakeholders ask for more time to transition EUA devices, diagnostics, 25 March 2022, Regulatory Focus).

“We're sort of waiting on that time to come,” he said. “The device side has many more products because it includes all sorts of tests and things that don't usually have the same level of study that would be needed even for a EUA for a drug. So, there's work to do there but there's definitely a plan,” he said.

Califf wants to create incentives for FDA commissioners to stay longer

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