The upheaval of the Health and Human Services workforce and leadership leaves much to be desired in terms of delivery, recently retired FDA Chief Information Officer Vid Desai tells BioSpace, but the regulatory agency is evolving to be more open to much needed change.
The FDA currently captures but a fraction of adverse events linked to therapies on the market. By some widely cited estimates, it could be as low as less than 1–10% for serious adverse events; best-case scenario is maybe one-third. Vid Desai describes a future where the FDA processes 90–95% of drug reactions and regularly sends inquiries to drugmakers.
“That’s the change I want people to think about,” Desai, an industry veteran who recently retired from his role at the agency’s executive table as CIO, told me during a recent BioSpace event. “It significantly changes how sponsored companies are going to be operating.”
His vision is much improved drug safety through the integration of electronic health records with AI-enabled copilots. These copilots would work closely with FDA staff to determine when follow-up is needed, he described.
“Now this might sound far-fetched but let me tell you that systems like this already exist today, and most of you have probably already interacted with or used these types of systems,” Desai said. He drew the parallel to credit card companies that detect fraud and send users alerts in real time. That’s how safety surveillance could work, he said, if current obstacles such as a lack of funding could be overcome.
A push for this type of change was already underway before Desai left his post as CIO. “We were already looking at funding, which is one of the key obstacles that we had in building such a system, he said.” Desai specifically pointed to HR, finance and procurement. “Frankly, we were spending more on those areas than we were on submission reviews or city surveillance systems, and that’s something we recognized needed to shift.”
In addition to funding hurdles, Desai described an inflexible culture that was wary of change. Then in January, as one of his first executive acts, President Donald Trump issued an order that for every new regulation, 10 must be repealed. Prioritizing deregulation could push the FDA toward this more back-heavy approach by providing an easier path to market and shifting emphasis to safety surveillance, Desai argued—and the administration’s wide-reaching government overhaul may be the starting point.
“One of the legacies that I think this administration will potentially leave behind is they’ve actually broken the can’t-do culture that used to exist in government,” Desai said.
Trump Breaks the Mold
On April 1, Desai was among the thousands at HHS to suddenly be told their jobs were being cut. In June, he and other HHS leaders filed a lawsuit alleging the reduction-in-force (RIF) decisions were based on bad data—something Health Secretary Robert F. Kennedy Jr. admitted to as hundreds were hired back.
“I think many of us wish that the change was executed in a more thoughtful manner,” Desai said. “There’s a lot of change going on, and I think as I speak to my former colleagues, it just feels very chaotic right now.”
Nevertheless, he applauded the initiative. “Much of the intent of this administration makes good sense. In fact, I welcome it,” he said. “Nobody looks at the government and feels like, you know, it’s good enough. We should change government.”
Desai gave the example of a large IT team with a supervisor for every two people. “Obviously you don’t need 300 supervisors to manage 600 people,” he said. “That would be some extreme variant of well managed.” But due to what he called “some ridiculous rules about restructuring the reorganizations,” HR informed him that reducing the number of supervisors “would cause harm,” he recalled, and was therefore not permitted.
“When we were trying to drive change within the FDA, there was a lot of, ‘You can’t do that. We won’t do that,’” he said. “There was a lot of resistance to change.”
But under Trump and Kennedy, that attitude is now changing, Desai reiterated. “I think this administration has pretty much broken that, and that’s a good thing.”
A Future of AI-Enabled Possibilities
Desai is the first to espouse on the game-changing nature of AI across the industry. But the application of the technology is one area where he vehemently opposes Trump’s methods.
“AI is going to be a game changer,” he said. “But I don’t believe AI is going to replace people. I think that’s one of the things I fundamentally disagree with this administration, and much of the initial DOGE planning was, ‘Well, we’re just going to use AI, and we need 20, 30% fewer people.’ I think that’s nonsense.”
The way AI should be applied, Desai said, is as “a productivity multiplier”—helping people do their jobs more efficiently. Traditionally, the government scales “by asking for more budget so that they can throw more people at a problem,” he lamented. “That’s the linear way of scale. And frankly, it doesn’t work.”
To scale exponentially, we need good technology used well, he continued. AI-based copilots, such as those now provided by many workplace apps, are the future, he argued. FDA copilots could help review submissions, train field inspectors and detect adverse events. “That doesn’t mean that they’re going to replace people,” Desai said. “It means these are tools people can use to make themselves more productive.”
We live in a very polarized world right now, and one of the biggest concerns, one of the biggest threats to our healthcare system, is misinformation and disinformation.
That’s a far cry from the AI solutions so far implemented at the FDA, he noted—what he called “a Google search on steroids.” The systems he envisions would take time and money to develop and implement—something that has to this point been hard to come by, said Desai. He argued that the FDA needs to do a better job advocating for the funding—from industry and from Congress—to truly evolve and scale.
Another consideration with the massive level of data sharing Desai foresees will be data security. Desai doesn’t see this as a concern in practice but worries that misinformation about patient privacy will stall progress. “We live in a very polarized world right now, and one of the biggest concerns, one of the biggest threats to our healthcare system, is misinformation and disinformation,” he said.
And, of course, the most immediate threat is the continued turmoil within HHS. “There’s a lot of chaos. Strategy never happens in chaos,” Desai said. “So in the next couple of years, I think the FDA is probably going to hunker down into a survival mode type of an environment. . . . But I’m hopeful that a future administration will come in with some more thoughtful planning and execution to build on what this administration has started.”
Desai is so excited about the future of biopharma that he launched his own consulting firm to avoid fully stepping out of the industry in his retirement. With change in full swing and the science and technology as innovative as ever, Desai’s outlook is brimming with optimism.
“I am tremendously bullish right now,” he told me. “If we can emerge out of this chaos and hopefully get into a can-do and will-do or must-do culture, I think that’s a good thing and a good legacy to build on.”
