Seeking a new path for FDA regulation of revolutionary medical treatments


Researchers are developing therapies that could permanently alter a patient’s genes… . The early results are promising. Patients would live longer, better lives. …the potential savings for insurers—and for Medicaid—are enormous. But when?

Part of the answer depends on the Food and Drug Administration, where hundreds of applications involving gene therapy for various diseases are pending.

“It used to be that the model was to develop a drug that was going to be administered chronically over the life of a patient,” [FDA Commissioner Scott] Gottlieb says in a recent interview at the FDA’s headquarters. … And now, the model is to try to develop curative therapy,” usually a short course or a one-time treatment. “It’s a completely different therapeutic model. It’s a completely different payment model, and our payment system isn’t adapted to that.”

Related article:  Genetic tests by Inova draw warning letter from FDA, citing potential for 'serious health consequences'

Is the regulatory system? The FDA is used to reviewing synthetic chemical drugs, but much of the innovation today is in “biologics,” treatments derived from living things, a category that includes genetic therapies. …

The FDA already has a route known as “accelerated approval” for drugs whose trial results are believed “reasonably likely” to predict clinical benefit. The early approval is then intended to be cemented over time with long-term data. Dr. Gottlieb says this process is well-suited to the new challenge of genetic therapies.

Read full, original post: When Medical Innovation Meets Politics

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