Califf: ‘Enormous’ implications for FDA if user fee programs are not reauthorized

Regulatory NewsRegulatory News
| 12 July 2022 | By Michael Mezher 

FDA Commissioner Robert Califf

In a tumultuous year coinciding with the agency’s five-year user fee reauthorization cycle, US Food and Drug Administration (FDA) Commissioner Robert Califf discussed his priorities for the agency and what happens if its user fee programs are not reauthorized before the current programs expire.
 
Califf made the remarks and shared his three- to five-year vision for the agency during a virtual meeting with the Alliance for a Stronger FDA on 12 July.
 
User fees and appropriations
 
Califf spoke about FDA’s budget priorities and discussed the agency’s two primary sources of funding – appropriations and user fees – both of which are up against tight timelines on the Hill.
 
When asked what would happen if the user fee programs were not reauthorized by August, Califf said the implications would be enormous.
 
“On the medical products side, this is a very significant part of funding and basically we’d have to lay people off,” Califf said. “We’re in the period of the ‘Great Resignation’ … who wants to work in an organization if you’re afraid that these jobs are not even going to exist in the next short period of time? We really need to avoid that.”
 
“If the user fees are not funded, we’ll review products as quickly as we can, but the timelines go away and the commitment to the timelines goes away,” Califf said.
 
When it comes to the agency’s broader budget, Califf said his top priorities are offering competitive salaries to maintain staffing, bolstering the agency’s food program, and enhancing its information technology capabilities.
 
“Having worked at Google for five years … Federal computing is not quite the same as what I got used to in my Silicon Valley life. Imagine FDA employees who had access to the current type of technology so that, for example, rather than entering data when you do an inspection, you just take a picture and use standard AI to fill in a lot of the characteristics of what that item is in the audit. These technologies are becoming available but it’s going to take funding,” Califf said “We’ve got all these legacy systems – you can’t just do away with them because they’re being used every day. There’s a cost of making that transmission.”
 
However, the agency faces the distinct prospect of going into FY2023 with a flat budget if forced to operate under a continuing resolution and must brace for the possibility of layoffs if its user fee agreements are not reauthorized by the end of the fiscal year.
 
Operating under a continuing resolution “puts limits on what we can do,” Califf said. “We’re going to have a growing number of predictable surprises if we don’t have the flexibility and the ability to grow and start new programs.”
 
Califf said he hopes that isn’t the case, but if it is, “We’ll be constrained in what we can accomplish on behalf of the public.”
 
FDA as referee
 
Tom Kraus, VP of government relations at the American Society of Health-System Pharmacists, asked Califf about his vision for FDA in the next three to five years.
 
Califf said that the FDA is like a referee for medical products, foods and other regulated goods. He noted that the agency has some input into the rules by which it judges products but must adhere to the rules once they are made, and to do so, must have a lot of specific expertise and situational awareness.
 
“[FDA’s] fundamental refereeing job, particularly on the medical product side is robust and bolstered by decades of precedent and the building of machinery which is highly effective – and now super-bolstered by the 21st Century Cures bill,” Califf said, calling that law and its enhanced hiring authority a “tremendous asset.”
 
Califf noted that the agency’s food center has not received the same attention in recent years. “On the food side, it is well-known and much discussed that we’ve got work to do, but there’s also been massive underfunding over the years,” he said.
 
“In addition to sort of fixing up the parts of the FDA which haven’t gotten the attention they deserved … what I’d say is we’ve got to focus on some meta issues which are going to have a big impact over three to five years,” Califf said, citing misinformation and evidence generation as some of the issues he would like to see addressed in that timeframe.
 
Misinformation is “not just an FDA issue, it’s a science issue in general, and an issue for all other federal agencies and clinical practices. People are being distracted by mis- and disinformation,” Califf said.
 
“FDA does really well when it applies a set of rules to a set of data which is high-quality data. When the evidence is good, we still have arguments about how to interpret it, but it’s entirely different than when FDA has to make a decision, let’s say with a court-mandated date or a user fee-mandated date, the evidence is not adequate to be entirely clear, and yet a decision is still needed. That’s when we really have a whole different kind of argument which is not beneficial,” Califf said.
 
“Our delivery of evidence to support decision-making is a fraction of what it ought to be given the technological expertise that we have globally and in the United States,” Califf stated.
 
Three years from now -- after the next presidential election -- Califf said he’s hoping to turn over an FDA “which is bolstered by much better evidence and with a winning strategy on how to counter misinformation.”
 
Turning back to evidence generation, Califf said that evidence generation, outside of early phases of development, “Is mediocre at this point.”
 
“I think we do a really good job of developing medical products up through the early phases. That system works well; it’s very expensive, but it delivers a quality product. If you ask the question ‘do we understand what the right doses of drugs are, how to use devices, how to combine and compare choices that we have to make with medical products?’ I’d say we’re doing a lousy job of generating that evidence. And yet, everyone in the United States has an electronic health record packed full of data that could be used to do studies very inexpensively.”
 
Califf stressed that improving postmarket evidence generation is especially important when it comes to accelerated approvals.
 
“I think it was a signal to the very broad community when the initial statement was it would take nine years to do the follow-up study on Aduhelm [aducanumab]. People said, ‘Wait a minute, that doesn’t sound like a timeframe that’s reasonable,’” Califf said. “You’ve got to ask what’s the system that would generate the evidence that we need for those sorts of postmarket studies?
 
“Good would look like: Every time there’s a medical product, we would understand the benefits and risks and understand how the product should be used in practice so that the labels were actually informative to the people that have to make the decisions,” Califf added.

 

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