May 31, 2023 – In an exclusive interview with WebMD's Dr. John Whyte, FDA Commissioner Dr. Robert M. Califf talks about how artificial intelligence could change the longer term of medication, what the FDA can and can't do about drug shortages and misinformation, and why it's an exciting time for the agency.
“Let's talk about what everyone is talking about: artificial intelligence, digital tools, ChatGPT,” said Whyte, WebMD's chief medical officer.
The potential of AI depends upon the way it is used, Califf said. “It could be used for enormous benefit, but also for enormous harm.”
Califf is “very excited” in regards to the positive developments. AI could lead on to recent treatment methods or find relevant information for a selected patient from knowledge databases “that are simply very difficult for us humans to access and take into account.”
Getting too excited in regards to the potential advantages of AI isn't a great thing either, because “you might not see the downsides,” says Califf, who's conversant in the technology because he was formerly head of healthcare strategy and policy at Verily, a subsidiary of Alphabet, Google's parent company.
Curbing misinformation
Another reality in 2023 is widespread misinformation about health and medicine. Califf called this “one of the leading causes of preventable deaths.”
The FDA is learning more about how misinformation works and why it spreads so quickly on the Internet. The agency also wants to search out solutions, “but I haven't found anyone who thinks they have the right answer,” Califf said.
In the meantime, it's important to reply quickly when misinformation begins to flow into and to revive trust in our key institutions as sources of reliable information, he said.
Combating drug shortages
Whyte asked Califf about drug shortages, citing Adderall for example.
Many people think the pharmaceutical industry is one thing, Califf says, nevertheless it's actually two. There's an progressive industry that develops recent drugs, and a generic industry that accounts for about 90% of all prescriptions. The profits of the progressive industry get a whole lot of attention, he says, while the shortage of profit as an incentive for generic manufacturers is just not as big.
“This has caused a major problem. Many generic drugs are constantly in short supply because the profit is not sufficient.”
Adderall is a special case since it is a controlled substance and the prescription amount is controlled by the Drug Enforcement Administration. There has also been a “huge increase in prescriptions” attributable to virtual prescriptions, Califf said.
Occasional quality problems that result in production interruptions also lead to shortages of many medicines.
“We wish we could fix all of these things,” Califf said. “But we don't make the drugs, and we can't tell anyone they have to make drugs.”
Enthusiasm on the helm
Despite these challenges, Califf stays optimistic. “It's just amazing to see the progress in science and medicine.”
“What I'm most excited about is the opportunity to change public health,” he said. The FDA is just one in all many players that must work with the CDC, the National Institutes of Health, the Centers for Medicare and Medicaid Services and the private sector. “This is really important. We need to make it work better.”
Although the changes involve a whole lot of work, Califf said, “It's an exciting time.”
Watch the complete interview with Califf on Medscape Here.
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