The Texas Medical Board ruling that stem cell use is the practice of medicine and not the creation of a new drug has brought up some interesting issues. Continuing along the lines of the cells= drugs discussion, what happens if I turn your cells into drugs? There are certainly bioethical concerns like whether you can use them to save your life-you can’t unless they are approved as a drug for that purpose. Then there are practical concerns. Since we have many more physicians than drug factories, how big would FDA have to be to supervise or monitor physicians using stem cells to ensure they weren’t the type FDA thinks are new drugs?
There are almost 1 MM US physicians. There is one FDA which is overburdened and underfunded. There are 50 state medical boards who are charged with overseeing physicians while FDA is strictly prohibited from having authority over physicians. Even if congress decided tomorrow to grant FDA regulatory authority over physicians, it would have to increase the size of the agency by more than 10X just to keep up. For example, FDA performed 200 ex-US drug manufacture inspections in 2008, in 2009 it had only two inspectors in China-where many of the drugs in the US are manufactured. In the US and elsewhere the agency does about 1,000 annual drug manufacture factory inspections. To police physicians, it would need to increase that number 10x just to have a very poor surveillance program (inspecting about 1% of physicians per anum). In addition, the efficiency of these inspections would drop off a cliff. Right now FDA can safeguard the health of millions of patient doses by inspecting one large drug factory. If they were inspecting physician offices, that efficiency drops to at best tens to hundreds of doses per inspection (for autologous ASCs). So the numbers above would need to increase by at least 1,000X to monitor 1 million US physicians using stem cells at the same level of surveillance as exists now. That overall 10,000 X increase in FDA size would take it from about 12,000 employees to somewhere north of ten million, making it by far largest federal agency and larger than the rest of the federal government. The upshot? Texas has the equation right. Let state medical boards regulate physicians and put protections in place to protect patients when stem cells are used as investigational therapy.