# Tuesday, 17 August 2010
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Most of the time, the FDA is a valued oversight organization protecting all of us and assuring that new drugs and devices are safe and useful. Is there a point where it begins to act like big brother, attempting to limit our personal choice? Where is the line between these two extremes?

As reported in a recent article on Nature.com, the FDA is seeking an injunction against Regenerative Sciences, a company specializing in use of patients’ own stem cells obtained from their bone marrow to accelerate healing of orthopedic injuries. The FDA wants the company to stop using the procedure because it is considered unproven. In addition, the methods used may not be up to “good manufacturing practice” standards for processing biologic materials. By classifying the re-injected therapy as a drug, the FDA claims jurisdiction over its medical use.

Certainly, the FDA has a stake in assuring that the processing of the materials does not place anyone at risk. Assuring proper safety is a vital government function. But does the government have a stake in preventing patients from using their own cells to improve healing? Perhaps this product has not been proven in a rigorous scientific study, but there are multiple examples in peer reviewed medical literature dating back over a decade of small studies using unprocessed bone marrow cells to accelerate bone healing. The FDA has never sought to regulate this process which involves removal and immediate re-injection of bone marrow cells into fractures. One of the barriers to effective therapy with bone marrow cells, however, has been the inconsistent concentration of stem cells in marrow aspirates. Regenerative Sciences claims to have overcome this problem with their process but, in doing so, may inadvertently have subjected themselves to the review and regulation of the FDA.

Should you and I be prevented from trying a therapy like this if we have a slow healing fracture and our orthopedist believes it could help? Does the processing of the cells really make this different than transferring cells directly from the marrow to the fracture? Is the FDA trying to protect us or is it trying to extend its regulatory jurisdiction and power? When exactly does the government have an interest in restricting us from using cells from our own bodies? If the procedure is safe, we are paying for it ourselves, and we are aware that it is not an FDA-approved procedure, aren’t we sufficiently protected?

Although Regenerative Sciences may not turn out to be an ideal example, the questions that are raised by this case will become increasingly important as the technology develops for manipulating our own stem cells for therapeutic use. We need a consensus of the scientific, medical, medical ethics and regulatory communities, not a court decision, to best determine the way that these issues should be handled. The FDA should be looking for answers to these questions, rather than seeking injunctions that will slow development in this important area of medical research.

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