FDA Not Satisfied with Just 25 Percent of the U.S. Economy


The agency now aims to regulate your body's cells. Some researchers and physicians have been taking adult stem cells from individual patients and reinjecting them to treat various medical conditions. While certainly not the standard of care yet for treating many ailments, progress is being made. For example, European surgeons have grown and transplanted tracheas using stem cells taken from individual patients. One stunning success is the case of Ciaran Finn-Lynch who received a transplant of a trachea grown using his own stem cells. That operation did not take place in the U.S.

Now the Food and Drug Administration has won a federal court case that allows the agency to regulate adult stem cell treatments as though they are pharmaceuticals. This will do for stem cell research what FDA regulation has done for drugs—slow progress and make treatments much more expensive. As former FDA deputy commissioner and physician Scott Gottlieb and attorney Colleen Klasmaier explain in their Wall Street Journal op/ed [sub required] today: 

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…

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…

…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.

As I have pointed out before, speeding new treatments to patients saves lives, delays kill:

A 2005 National Bureau of Economic Research study found that, on balance, the faster FDA drug approvals made possible by new funding legislation passed in the 1990s saved far more lives than they endangered. In fact, new drugs saved up to 310,000 life-years compared to 55,000 life-years possibly lost to the side effects of drugs that were eventually withdrawn from the market.

Both Gottlieb and Klasmaier disclose that they work with companies that are developing cell-based therapies. For more background on FDA overregulation and overcaution, see my columns, "Timid Bureaucrats Kill People," and "Building a 21st Century FDA."