In today's Wall Street Journal, American Enterprise Institute (AEI) resident fellow and former Food and Drug Administration (FDA) deputy commissioner Scott Gottlieb, MD explains that the FDA's attempt to regulate cells as drugs could halt one of the most promising areas of medical research.
- FDA wants to regulate cells: "At issue are cells taken from our own bodies and then re-implanted with the purpose of treating medical problems. The most inspiring work involves adult stem cells, although the court's ruling in principle extends FDA oversight into things as common as in-vitro fertilization--basically turning reproductive cells into "drugs" under the law." Two weeks ago, a United States District Court ruled that adult stem cells are drugs, and thus subject to FDA regulation.
- FDA regulations hamper unique procedures: "Doctors will now try to convert procedures into products that can fit FDA's regulatory rubric….Not every cell procedure will lend itself to this sort of revision. How, for instance, would you run a large-scale, randomized trial and ensure consistency from one use of a drug to another, where the "drug" is really a medical procedure that must vary from one patient to the next because it involves their own unique cells?"
- Pushing innovation outside of the Untied States: The company involved in the court case, Regenerative Sciences, has moved some labs to the Cayman Islands. Most of the adult stem cell science research is being done in Britain, Singapore, and Israel "precisely because of the FDA's bent to hold with misgiving anything novel in medicine."
"The FDA is perennially complaining to Congress that it lacks the resources to do its day job of regulating products that fall squarely in its purview. Yet in chorus, the agency is always seeking novel authority to insert itself into new areas of science where its mandate is shaky…[this goal] can be deadly when it comes to the agency's impulse to regulate, and thus forestall, cell therapies used to help repair damaged body parts."
Scott Gottlieb is a practicing physician and resident fellow at the American Enterprise Institute. He was deputy commissioner of the FDA and a senior adviser at the Centers for Medicare and Medicaid Services. He can be reached at email@example.com.
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