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FDA Commissioner Makes Six-Part Call to Action to Improve Health Care

Robert Califf aims to better leverage health technologies to advance health care and equity.

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Food and Drug Administration (FDA) Commissioner Dr. Robert Califf announced a six-part call to action to better leverage health technology, data and capabilities to improve health care, outcomes and equity.

Califf highlighted during Health Datapalooza Monday that the U.S. has seen the rapid growth of data science, management and analysis with technology and medicine over the years, but these advancements are maligned with current health systems to achieve equitable and quality health care.

Amid rises in health care technological capability, Califf noted that the average life expectancy across the country has dipped significantly since 2010, calling for a realignment of medical capabilities and the way we strategize and use them across society.

“I completely believe having lived in the highest tech environment in the world that the major limitations are not technology at this point,” Califf said. “The limitations all have to do with human interactions, so now’s a really good time to rekindle societal discussions about the advantages of sharing data, and the best rule is to ensure that data are used for good purpose.”

To overcome these limitations, Califf presented a six-part call to action for private and public entities to help solve that is “totally self-centered about FDA.”

The first point is a call to create a better system of evidence generation for decision-making.

“Despite all of our magnificent efforts, less than 20% of clinical practice guideline recommendations are based on high-quality evidence,” Califf said. “How can that possibly be, given all the research that we’re doing? The system is inordinately expensive, cumbersome and fails to take advantage of technology and the changes in technology and the vast reach of digitization.”

Second, Califf said that FDA and the health community need to revamp the public health information architecture. He and other leaders at the Department of Health and Human Services (HHS) have realized that COVID-19 and other public health decision-making has been conducted with “a fraction of the decision support that we know is possible with today’s technology.”

Califf noted that technology today is capable of creating public health trackers for all diseases and the possibility of solving public health challenges through data-sharing in a way that protects individuals’ information and privacy.

“We can account for geospatial and temporal changes, and it can be refreshed on a timescale completely suited to day-to-day decision-making or month-to-month or year-to-year, but we don’t have that right now,” Califf added. “We have a slow, cumbersome, fractionated, difficult-to-put-together public health information system.”

Califf’s third call to action was to close the gap between FDA approval and the appropriate use of products and payments.

“We need the evidence fabric to fill in between the time when FDA says there’s a product where the benefits outweigh the risks or unintended use in a given population and when that product is deployed with payment across the entire United States,” Califf explained.

With such a system for medical products, FDA could in advance pay for effective technology and practices while eschewing ineffective solutions more quickly.

The fourth call to action is to aggregate available information in a way that supports consortia driven by patients, as well as their families, caretakers and clinicians, Califf said, arguing that the current status quo does not promote patient-centeredness. With this point, Califf said he hopes that each stakeholder in health care can better collaborate to optimize the patient experience rather than each of their own.

“We need consortia to work together, and I would point you to cystic fibrosis, multiple myeloma and type-one diabetes as amazing examples [of how this works],” Califf said. “Cystic fibrosis along during my career — we’ve seen a 25-year increase in life expectancy, and it’s only partly due to new products. A large part of it is just holding the rest of the ecosystem accountable for serving the needs that these patients have rather than their own needs.”

Fifth, Califf called for health entities to consciously create incentives that “reduce some optimization and improve assessment of the impact of subsystems” on overall outcomes for individuals and populations. He argued that as long as every health subsystem is optimizing its own wellbeing financially, service and care to people will not improve meaningfully.

In his final call to action, Califf stressed that the country has to tackle misinformation and improve education about science. While he said that this has been especially important amid misinformation about COVID-19 vaccinations and treatment over the past two years, improper knowledge about health and medicine has reduced the life expectancy of misinformed populations for years. He added that this is especially evident in rural areas.

“If we look at what’s driving this rural decline in life expectancy, it has everything to do with information that people are getting on a 24-by-7 basis,” Califf said. “At every level of our system, we’ve got to be aware that people are not spending their time in our clinics or listening to our erudite lectures. They’re at home getting 24-by-7 social information and information from others, and we have to have a solution to that … in every part of the ecosystem.”

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