The FDA wants to regulate your cells
We're on the verge of being able to repair damaged parts with our own tissue. But the research is being stymied in the U.S.

NIH

This photograph shows Faye Chen, Ph.D., and Wesley Jackson, Ph.D., volunteer postdoctoral fellow, examining a femoral head that was recovered from total hip replacement. From this femoral head researchers harvest adult mesenchymal stem cells.

A recent decision by a federal trial court gave the Food and Drug Administration the latitude that the agency has long sought to regulate our cells as drugs. It could put the brakes on one of the most promising areas of medical research.

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 adult stem cells can differentiate into many kinds of finished tissues. This enables doctors to use these cells to renew damaged body parts. This science of regenerative medicine has promise across many fields of medicine, from cardiology to brain diseases to orthopedics.

Obtained from bone marrow in accessible sites like the hip, the adult cells are isolated, grown in a lab, and returned to their donors as part of individualized treatments devised by doctors. Because the cells aren't products developed on a large scale and sold on the market, they were never subject to FDA's usual oversight.

But two weeks ago the United States District Court for the District of Columbia ruled in United States v. Regenerative Sciences LLC that adult stem cells are drugs, even when taken from a person and then re-inserted into the same patient.

The case involved a group of Colorado physicians who developed a process using adult stem cells to help patients with orthopedic injuries heal faster. The district court accepted uncritically the government's sweeping position that a cell returned to the same patient in these office-based procedures could be a drug.

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 the FDA's victory is upheld on appeal, then conceivably nothing done as part of clinical practice is beyond the agency's reach.

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.

"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." -- Scott Gottlieb, Coleen Klasmeier

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.

Dr. Gottlieb is a resident fellow at the American Enterprise Institute and former Food and Drug Administration deputy commissioner. Ms. Klasmeier is head of the FDA practice at Sidley Austin LLP and previously worked as an attorney at the agency. Both authors work with companies developing cell-based therapies. 

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