Wednesday, December 16, 2015

California Stem Cell Agency: FDA No. 1 Impediment to Stem Cell Therapies, 'Patients Are Dying'

California’s $3 billion stem cell agency this morning made it clear that it is not backing away from taking on the $4.9 billion Federal Drug Administration(FDA).

Randy Mills, MCC photo
“Patients are dying” because the federal government is “being so careful about safety,” Randy Mills, president of the agency, said in an item on its blog, The Stem Cellar.

 “Doing nothing is not okay,” said the headline on the piece, written by Kevin McCormack, senior director for communications for the agency. 

The FDA is too slow, too concerned about safety and needs to remove rules that are “bad for patients and regulators,” said the item.

Mills has been beating a drum concerning the FDA for a number of months, citing a non-scientific survey of agency stakeholders that showed 70 percent of them identified the FDA as the No. 1 impediment standing in the way of CIRM’s goals. 

Significantly, McCormack’s piece comes one day before the board of the California Institute of Regenerative Medicine (CIRM), as the agency is formally known, meets in Los Angeles to approve a plan that includes 50 new clinical trials over the next five years. All of those trials require FDA approval. 

In the proposal, Mills identifies FDA foot-dragging as one of the risks to successful completion of the $890 million effort.

 McCormack’s item said CIRM is “caught between a rock and a hard place. And CIRM is going to try and help them get out from under that.”

He quoted Mills’ speech to the World Stem Cell Summit last week. Mills said,
“We have had the current FDA regulatory structure for cell therapy in place for 15 years, and in that 15 years not one stem cell therapy has been approved. The scoreboard is not lying, there’s a zero on it. Not one therapy has been approved. There is an issue here, we can’t ignore that fact and so we made it part of our proposed new Strategic Plan to try and remove this burden. 
“There is an excessively long translational pathway to get an Investigational New Drug (IND) approval from the FDA (a necessary step to proceed with testing a therapy in a clinical trial). For non-cell therapies it takes 3-4 years to get an IND. For cell therapies it takes 6-8 years, twice as long.” 
Mills continued,
“We are not anti-regulation, we are not anti-FDA, and we are not calling for the removal of rules and regulations around stem cell therapies, that would be bad for patients and research. These therapies have risks and we are not proposing any strategy that puts things on the market without any testing or safety data. But right now we are being so careful about safety to ensure patients are not put at risk while those same patients are dying from their disease.”
In addition to Mills, one of the speakers at the World Stem Cell Summit was from the FDA. He said the primary mission of the FDA is safety. On the other hand, the mission of the California stem cell agency has long been “to accelerate stem cell therapies.” 

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