Turning Body Parts into Drugs: Geron ceases Stem Cell Approval citing Regulatory Costs
Wow, what a bombshell this morning. Geron was one of the big dogs in the stem cell business world, most recently in the news for the first FDA approved spinal cord injury study. Yet the company just pulled all funding out of pursuing U.S. FDA approval for stem cells citing the excessive costs of the research required by U.S. FDA to turn it’s stem cells into an approved drug. With biotechnology funding down in stem cells due to regulatory hurdles, this Geron announcement is a huge problem for the regulatory status quo. It means that many companies are likely to follow by either moving their technologies out of the U.S. for approval or pulling the plug on their US FDA research. This “brain drain” is leading more companies overseas where regulation makes more common sense. What’s needed? A new model that balances safety and efficacy concerns rationally and that moves stem cells from the “drug approval” approach pushed by U.S. FDA to the registry approach being pushed by physicians. A registry approach is one where patients are treated in a safe and controlled manner using a new technology and all data is collected for later review. An Institutional Review Board decides what’s safe enough to allow testing and the results are published with patients and doctors making up their minds about risks and benefits. In addition, while the FDA has pushed chemical drug concepts like “Purity and Potency” onto cell therapies, the registry approach would recognize that these cells are body parts and as a result, are only as good as the tissue from which they originate. The upshot? Turning body parts into drugs is at best fitting a square peg into a round hole and at worst a recipe for the financial disaster (one that’s being played out right now). There is no benefit to society to take the cells in our bodies and pretend they are the same as chemical drugs-period.