The Food and Drug Administration (USA) has decided to go for a two day hearing with the biotech companies over the issue to approve clinical trials for the first generation of stem cell derived drugs. The biotech industry wants FDA guidelines for the complex approval process and very much expects its opinion to be free from political influence.
California based Geron Corp. is going to be the first company to file embryonic-stem-cell proposal to FDA. If approved, the company could begin human testing of a therapy to repair acute spinal injury which is likely to be a steping stone is stem cell research as well as treatment.
The biotech industry experts fear adversarial measures from FDA as it is under tremendous political pressure. They are afraid of the unresolved safety issues related to embryonic stem cell technology. One of the most-critical problems the FDA must tackle now is how to determine the length of time for a stem cell trial in animals before proceeding to human testing. The hearings could provide a stage for some companies to make a splash about new cell-based drugs in development.
Source: WSJ [online.wsj.com/article/SB120779366925203837.html] (requires registration)