FDA regulator: Medical innovation won't work without major changes to healthcare

Significant reforms are necessary in researchers' relationships with drug regulators and physicians to ensure their discoveries are accessible to those who need them most, according to Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research.

As is, the current healthcare ecosystem discourages collaboration, preventing many potentially life-saving treatments from ever making it from the lab to the clinic, Dr. Woodcock said at the Breakthroughs in Medicine conference on Sept. 6, the Los Angeles Times reports. When drugs do begin the process of commercialization, they are shrouded in a level of secrecy that makes clinical trials excessively costly and fragmented.

"The goal isn't just improving knowledge. The goal isn't FDA approval. The goal is to improve human health," she said. "Is the guy living under the bridge going to get a $2 million CAR-T cell curative therapy? If that guy can't get the drug, then we've failed."

To solve these issues, Dr. Woodcock suggested that researchers not only welcome physicians into the drug discovery and development process, but also use EHRs and other sources of big data to develop treatments that can have the broadest impact.

"You can’t just develop breakthroughs and then throw them over the wall to practitioners," she said, per the Times. "We need the whole system to evolve and change if we're going to do what we set out to do: help every patient feel better and live longer."

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