Califf lays out vision for connected healthcare ecosystem

Regulatory NewsRegulatory News | 04 April 2022 |  By 

In one of his first public addresses since becoming commissioner of the US Food and Drug Administration (FDA) for the second time, Robert Califf outlined some observations about the state of play in the healthcare sector, as well as some of his priorities surrounding data and evidence generation in his recently reprised role.
Speaking at the Health Datapalooza and National Health Policy Conference in Arlington, VA on Monday, Califf said that health systems need to be better aligned to improve outcomes for patients across the board. Many of his priorities echo those from his first stint as FDA commissioner during the final year of the Obama administration. (RELATED: Califf: Leveraging real world evidence is 'top programmatic priority' for FDA, Regulatory Focus 11 May 2016)
“I’m going to paint a relatively pessimistic picture hoping that it will stimulate you to fix it,” he said. “Because we need some fixing right now. The sort of bottom line for me is that data science, that intersection of technology and data management analysis, is advancing at an amazingly rapid pace. I just spent five years at Alphabet and really got to see what's in play and participate in it. But I believe our current systems are malaligned, if the goal is to support decision-making that will improve health for individuals and populations in an equitable fashion.”
Califf said that improving these fields will benefit all stakeholders, not only those the current system is working well for. “I completely believe having lived in the highest tech environment in the world, that the major limitations are not technology at this point. The limitations all have to do with human interactions,” he said.
As an example of an area where systems are not transparent or as interconnected as they could be, Califf pointed to the healthcare supply chain, which he recently focused on as a member of the National Academies of Science, Engineering, and Medicine’s supply chain security committee. Califf resigned from the committee after being nominated for the FDA commissioner role in November 2021. (RELATED: NASEM report: FDA should disclose drug and device manufacturing information, Regulatory Focus 4 March 2022)
“We had a bunch of people [on the committee] who were experts in supply chains who were not in the healthcare industry, and they were sort of amazed by the opaqueness and lack of transparency of the healthcare supply chain,” he said.
Stalled progress
Califf stressed that while business has been good for much of the healthcare industry in recent years, some outcomes for patients and individuals are not improving. “Most of the sectors that I'm dealing with as FDA commissioner are doing pretty well, financially at this time. Yet, the aggregate outcome is not going in the right direction,” Califf said, and asked “What if we align the business interests with the direction that we need to go?”
He also bemoaned the decline in life expectancy in the US in recent years despite healthcare spending tipping past the $4 trillion mark in 2020. He noted that the losses are more pronounced for some minorities and that life expectancy varies greatly – by as much as 20 years – depending on geographic location.

While urban areas and university towns have life expectancies that rival Scandinavian countries and Japan, Califf said that “Rural areas are experiencing a precipitous decline in life expectancy. In 1990, rural and urban death rates were almost identical. By 2016, there was a 20% higher death rate in rural areas.”
Califf said that part of the issue is the US’ failure to effectively implement its own innovations.
“In one sense, we're innovating, and clearly everyone in the world recognizes this. We are the innovation engine for the world in terms of technology. But it looks like the rest of the world is figuring out how to use our innovations better than we are,” he said.
Goals and challenges
Instead of staying on the sidelines, Califf said he views FDA as having an integral role in addressing some of these challenges. “FDA is like a foundational structure in the system. Rather than say it’s someone else’s problem, I’d rather build bridges to the other parts of the system and try to make them work better.”
“We need to revamp our system of evidence generation for decision-making,” he said. “Despite all of our magnificent efforts, less than 20% of clinical practice guideline recommendations are based on high-quality evidence. How can that possibly be given all the research that we’re doing?”
The FDA commissioner stressed that better evidence would lead to better decisions, even when it comes to controversial decisions.
“Even when it’s controversial – if the evidence is good – and people are looking at it with different interpretations, the heat emitted in the political sphere is much less than if we have to make a decision based on crappy evidence, and I’m afraid that too many [decisions] are like that.”
“We have a slow, cumbersome, fractionated, difficult to put together public health information system,” Califf said.
Califf also said that the “evidence fabric” needs to be woven together to fill the gap between FDA approval and the appropriate use and coverage of new products. “If we had such a system, at least for medical products, we’d advance and pay for effective technology and effective practices more quickly and eschew ineffective technologies earlier and more completely,” he said.

He added that the information needs to be aggregated in a way that supports patients, their families and caregivers, as well as clinicians, and stressed the need to reduce incentives that promote suboptimization to get to better outcomes.
“How can it be that we’re all having better quality and outcomes in every health system, and the aggregate is negative? It doesn’t make sense,” Califf said.
The FDA commissioner also decried the widespread misinformation that’s defined much of the debate over healthcare measures during the pandemic.

“Today, you make one statement at the FDA and it’s immediately supplanted by 24/7 counter information by people who have a different point of view,” he said, adding that more needs to be done to present transparent data to the public to combat such misinformation.


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