Trump's Pledge to Slash FDA Regulations Could Put Public at Risk

An accelerated review process and better tracking could do more to drive medical device and drug breakthroughs than a massive deregulation effort, healthcare leaders say.

This is part of a series covering the Shaping of Healthcare's Future in the Trump era.

A pledge by President Trump to slash regulations at the FDA may run into opposition from health leaders who believe innovation will proceed regardless of the level of FDA regulation, or that too much regulation-cutting could endanger patient safety.

President Trump has promised sweeping rollbacks in regulations across all agencies. But at the Food and Drug Administration, a focus on innovation would be a better way to safeguard patients and get new devices and medicines to market, says Eric Topol, MD.

"There is always a delicate balance between permissiveness and less regulation and oversight, as compared with promoting innovation and getting things out that could help people," he says. Topol is a cardiologist and chief academic officer at Scripps Health in San Diego.

"Setting the tone that we want to see more true innovation accelerated would be a good thing. Often it isn't just the commissioner per se that has the governance" but also those at staff level, he says.

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But Topol, author of The Creative Destruction of Medicine, cautions that accelerating innovation carries plenty of pitfalls, as when the FDA last September approved the drug Sarepta for muscular dystrophy.

"They approved the drug with 12 people, 12 kids, and no controls," he says. "This was not an example of acceptable, in my view."

If the Trump Administration opts for wholesale deregulation at the FDA without carefully considering the consequences, the approval process for devices and diagnostics will carry some of the same risks, Topol says.

"The FDA has been doing things to turn up the speed [of approval]," he says. "I'm hoping that we'll see consistent means of promoting [and] accelerating meaningful, proven innovation."

Instead of relaxation of FDA standards for new devices and drugs, Topol would prefer to see a revamped process for moving innovations through the FDA's pipeline.

The typical clinical trial process does not track every patient's progress via digital means. "I'd like to see [digital tracking] eventually be the criteria for all approval of everything at FDA related to medicine and healthcare, because we don't track this stuff today," he says.

Tracking Trials

Post-market surveillance studies, which are intended to monitor the safety of pharmaceutical drugs and medical devices after their release, "don't usually get done, they don't get reviewed, and they're not meaningful because they're not [done for] every single person, and that's where you really learn," he says.

Instead, too many drugs and devices today get pulled off the market in response to unanticipated untoward effects, Topol says. "Typically, they're known in the first year."

Topol suggests the FDA adopt a process in which makers of these devices and therapeutics apply for and receive rapid conditional approvals with a time limitation from the FDA. The process would digitally track all users of the device or therapeutic during the trial period, he says.

If time were to run out before the trial yielded results, the device or drug would come off the market. And it could not be advertised while under conditional approval, Topol adds.

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Innovators might object to an advertising ban during the conditional approval period, but "if you give them the choice of a rapid conditional approval in record time, versus… what usually happens, guess which one they would take," Topol says.

This kind of approval process could have prevented the harm caused by the arthritis drug Vioxx after it received FDA approval, he suggests.

"It was the biggest launch in history, at the time, of any pharmaceutical." If Vioxx had been given a conditional approval instead, "the heart attack problem would have been manifest, and you wouldn't have had 20 million people exposed [to the risk] right away."

Because conditional approval already exists but is not used often, the FDA need not enact new regulations, but could simply encourage use of conditional approval, Topol says.

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Increasing public pressure for clinicians to use new devices and therapies is one trend that will not slow during the Trump years, he says.

"There's an absolute need to have patient engagement in the design of all therapies, because what researchers think is important versus what patients think are usually quite different," Topol says.

Electronic health record vendors need to modify their products to make it easier for providers to track patients' use of devices and therapeutics, he says. Vendors could add this kind of tracking module to their EHR platforms, Topol suggests.

Innovation Continues
"Regardless of who's in the driver's seat at the Presidency level, what we need is not incremental innovation but massive dynamic transformational innovation," says Rasu Shrestha, MD, chief innovation officer at Pittsburgh-based UPMC.

When it comes to FDA regulations, "my personal wish is that we finally get to a place where we're actually solving intelligently for decreasing complexity in healthcare overall," says Shrestha, who is also executive vice president of UPMC Enterprises, the payer/provider's medical technology investment arm.

Regulations have to be eased with caution, Shrestha says.

"There are certain forces that historically have tended to drive FDA, and those forces are powerful and they remain firmly in place," Shrestha says. "One is unexpected safety events. You talk to anybody in this area and they'll always go back through the litany of safety issues that have driven the major strands of FDA thinking.

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"Now the mind shift is, how do we make intelligent decisions around what works for a single patient, leveraging capabilities with machine learning and artificial intelligence?"

Shrestha believes patients will lead the next wave of innovation. "If we're able to have patients be the arbitrators of their own data, I think interoperability will scale to a level that we've never imagined," he says.

Consumer-led innovation will have its own deregulating effect on the medical device industry. "I believe under the new administration… the transition from volume to value will actually not slow down. It's going to double down," he predicts.

As an incubator and investor in startup technologies, UPMC Enterprises leans toward letting a thousand flowers bloom.

"We need more transparency: price transparency, performance transparency, and letting the best solution win," Shrestha says. "Competition is not a bad thing. It keeps us honest."