“Common sense is not so common”-Voltaire
This spring, an important Wall Street Journal Op-ed by the ex-FDA commissioner called out the FDA for inhibiting progress by classifying our cultured Regenexx-C procedure a drug, pointing out the FDA’s cell regulation nonsense. Yesterday morning the Wall Street Journal published a second op-ed on the cells=drugs issue and the FDAs attempt to characterize the Regenexx-C cultured stem cell procedure as a drug – this time by a former FDA deputy commissioner and a former FDA attorney. What’s unique about this op-ed is that it shows great depth and breath of understanding of the non-sensical issues of turning a unique patient’s tissue into a drug. From the editorial:
“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.”
“The FDA has repeatedly sought to blur the line between manufacturing medical products and practicing medicine whenever new techniques emerge. But the standard for regulation isn’t whether the agency feels a technique is novel but whether it meets the definition of being a medical product.
Federal regulators have stretched that definition to the point where a reasonable limit no longer exists. The law provided a clear impediment to unrestrained exercise of FDA authority. Something needed to be an “article”—not a medical procedure—in order to become a drug. The constraint that a drug needed to be a “thing” has been read out of the law by FDA, and the district court appears to have accepted that position.”
“If human cells processed by the Colorado doctors are “drugs” under federal law, even when these cells are returned to the same patient who donated them, there may be little to prevent the FDA from imposing its drug-approval requirements on any cell-based procedure.
Doctors will now try to convert procedures into products that can fit FDA’s regulatory rubric. The science will be contorted to fit the regulation, rather than the other way around. 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? The FDA requirements, designed for products manufactured and sold on a mass scale, can’t be readily satisfied when it comes to treatments that are personalized to individual patients.”
“When the FDA seeks to hold physician procedures to the same rules as pharmaceutical manufacturers, invariably the doctors have no choice but to bow to regulatory pressure, stalling progress. Regenerative Sciences, the defendant in the case, has moved some of its labs to the Cayman Islands. Most of the science of using adult stem cells for regenerative medicine is unfolding 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 may all be mildly amusing when it comes to the FDA’s efforts to require pre-marketing approval of things like iPhone medical apps—a fight FDA recently won with Congress. But it 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.”
Thanks to Gottlieb and Klasmeier for bucking Voltaire’s thesis on common sense…