Last month, FDA commissioner Scott Gottlieb and Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, coauthored a special report in the New England Journal of Medicine entitled “Balancing Safety and Innovation for Cell-Based Regenerative Medicine,” in which they outline new regulations designed to expedite approval of stem-cell therapies to treat various diseases and disorders. Encouraging innovation is consistent with the direction that the FDA has taken under Gottlieb. These policies, however, especially concerning stem cells, represent an unfortunate entrenchment of the status quo.
Stem cells have numerous therapeutic uses, some of which have been controversial. One of the simpler treatments involves autologous stem cell transplants: a doctor extracts stem cells from a patient's body and uses them to treat a medical problem in the same patient. The procedure can be done in a day or over the course of several visits if the doctor chooses to multiply the patient's cells before reinjecting them—a process dubbed “cell culturing.” One key objection to unregulated autologous stem cell transplants is that transplanted cells may multiply, migrate, or metastasize in unanticipated ways. You get treated for a bum knee, the argument goes, and two years later, you have a tumor in your lung. In other words, like prescription drugs, stem-cell transplants come with the potential for unforeseeable, harmful side-effects, and as such need to be studied, approved, and fitted with an FDA warning label before being used.
