A San Antonio company is backing bipartisan legislation to loosen up federal regulation of developing stem cell therapies. The company says it would keep the U.S. from lagging behind other countries in the brave new world of regenerative medicine.
Studies show therapies using adult stem cells may provide novel new treatments for a litany of diseases, from Alzheimer’s to multiple sclerosis to diabetes. Despite that, there are currently no FDA-approved stem cell therapies in the United States.
Dr. Steven Davis is co-founder of the San Antonio start-up company StemBioSys Inc. He wants to see the process speeded up.
"I don’t think we should accelerate it to protect our economic interests," Davis said. " I think we ought to accelerate it to invigorate our health interests."
Davis says getting through the Food and Drug Administration approval process can be painfully slow.
"It takes 'x' number of years just to get it to FDA trials and once you get it there, it could take 10 years and $2 billion for the average drug to get there," Davis explained. "Small companies don’t have 10 years and $2 billion to spend."
StemBioSys Inc. has a patent on technology that helps grow stem cells. At least half a dozen other San Antonio institutions and companies are also working on regenerative medicine. The federal legislation to fast track some of their work is still in negotiation. Votes are expected in the House and Senate in September.
Opponents of the legislation say FDA safety measures trump the need for faster development.
