Jeb Bush’s FDA reform plan is spot-on

Jeb Bush recently announced his official healthcare platform. The resulting media coverage has focused mostly on his plans to repeal and replace Obamacare. But there’s another plank worth at least as much attention: modernizing the U.S. Food & Drug Administration.

The FDA’s approval channel for new drugs and medical devices is still too 20th century and significantly under-resourced. As a result, many promising products end up in regulatory purgatory, bogged down in needless requirements and bureaucratic delays. 

{mosads}Bush’s plan would streamline and update the FDA. New, potentially lifesaving treatments would get into the hands of patients faster. His plan would re-invent the regulatory process to make it an accelerator — rather than a roadblock — to innovation. 

Healthcare innovation saves lives and money, promotes economic growth, and provides hope for hundreds of millions of people all over the world.

Left unencumbered, domestic medical innovation will generate the new treatments that can help drive down long-term healthcare costs. As David Cutler, a Harvard University economist and adviser to President Obama, has noted: “Virtually every study of medical innovation suggests that changes in the nature of medical care over time are clearly worth the cost.”

Unfortunately, there are many regulatory hurdles stifling such innovation. Bush’s plan addresses some of the most crucial issues.

First, it would empower the FDA to use a broader body of evidence when making its evaluations. For instance, regulators could look outside the lab to patient-reported clinical outcomes. This provides a fuller picture of the risks and benefits of a proposed new drug.

Next, his plan would significantly accelerate clinical trials. Currently, medical researchers have to conform to rigid, pre-determined timelines that often move much slower than the pace of innovation. Under the Bush redesign, they’d be allowed to use patient data as it accumulates and modify their studies in real-time. There would be far fewer needless delays. 

Third, drug manufacturers would be allowed to provide scientific information and peer-reviewed clinical data with physicians and patients. That would enable doctors to recognize promising new treatments faster and start prescribing them to patients.

Finally, and perhaps most importantly, the Bush plan would significantly boost the FDA’s budget. Right now, much of the agency isn’t insufficiently resourced to make approvals both quicker and more safely. 

Jeb’s plans will bring new therapies to market quicker, which, in the long term, will lower costs by enhancing patient outcomes.

America’s regulatory environment must encourage the creation of the new drugs and devices that can save lives and drive growth. If government officials aren’t equipped to quickly judge and approve breakthrough products, or if firms are suffocated under excessive regulatory burdens, people all over the world will lose out on revolutionary new products.

Bush’s plan is a step in the right direction. He’s calling for some desperately needed reforms. Let’s hope other presidential candidates join him.

Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest.