FDA Versus Our Own Stem Cells – The Regulatory Review

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The federal government seeks authority over stem cell treatments but risks thwarting medical advancement.

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Two years ago, the U.S. Food and Drug Administration (FDA) filed a lawsuit in a federal district court in California that could determine the reach of its regulatory authority over how people use their own stem cells.

The FDA stem cell lawsuit has potentially precedent-setting implications for the future of stem cell and regenerative medical research, medical technology advancement in clinical applications, the expansion of patient health care options, and the control of the rise of private and public health care expenditures.

The repercussions of using human stem cells in medical research and practice could be the most seismic since Henrietta Lacks and her versatile HeLa cells. Lacks’s “immortal” HeLa cells have been used to study the effects of toxins, drugs, hormones, and viruses on the growth of cancer cells. They have also played a critical role in the development of the polio vaccine and in vitro fertilization