FDA Uncertainty Stalls Stem Cell Research

Geron Corporation, a top biotechnology company known primarily for oncology drugs, recently announced that it would be halting stem-cell research and laying off 38 percent of its staff. Geron Corp. has decided instead to focus on drugs that are easier to bring to the market and can provide a quicker return for investors and stockholders.

Geron Corp. was engaged in a clinical trial testing a stem cell treatment for spinal cord injuries and was in the early stages of development for therapies for Diabetes, Parkinson’s and Heart Disease. As the LA Times reported, “Industry watchers say the science of stem cell medicine remains sound. It's just the economics that are shaky.”

The shaky economics are due in large part to the incredible resources it takes companies to get through the FDA approval process. In Geron’s case, the FDA halted their trials at one point, only to allow them to start up again a year later. For firms pioneering entirely new classes of drugs, navigating the approval process is even more difficult than for traditional pharmaceuticals. Due to the insecurity brought about by the approval process, it is difficult for firms to gauge if and when they will see a profit on their investment. Investor confidence is necessary for firms like Geron to continue pioneering new treatments and, unfortunately for patients with spinal cord injuries and other incurable conditions, the uncertainty surrounding FDA approval means they will have to wait even longer for life-changing treatment.