FDA Hearings on Stem-Cell Drugs
By ALICIA MUNDY
April 10, 2008; Page D3
The contentious debate over embryonic-stem-cell research is entering a new chapter as biotech companies press the Food and Drug Administration to approve clinical trials for the first generation of stem-cell-derived drugs.
The FDA has set two days of hearings starting Thursday to discuss how the agency may regulate embryonic stem-cell therapies. FDA officials say they expect the hearing will draw a crowd of biotech executives, investors and researchers, and representatives of patient-advocacy groups.
The biotech industry and investors want more certainty about the FDA's guidelines for the complex approval process ahead, and assurance that the FDA isn't averse to approving embryonic-stem-cell therapies for political reasons.
One company involved in the hearings, Geron Corp., of Menlo Park, Calif., is set to file what it says is the world's first embryonic-stem-cell proposal with the FDA. If approved, the company could begin human testing of a therapy to repair acute spinal injury. The company expects to submit its proposal this summer.
During a conference call with investors this year, executives touted the upcoming FDA panel. "We are actually playing a very central role," said Chief Executive Tom Okarma, adding that the FDA had invited Geron to give "a major presentation."
"The FDA is nervous. It's under tremendous pressure. They can't appear adversarial but they can't seem to be rolling over for industry, either" said Richard Garr, CEO of Neuralstem Inc., which develops adult-stem-cell products. Mr. Garr said he is worried that if the hearings focus on unresolved safety problems in embryonic-stem-cell technology the FDA could decide to slow down the process of considering stem-cell therapies. "It's my nightmare scenario," he said.
The hearings could provide a stage for some companies to make a splash about new cell-based drugs in development or to prod the FDA on shifts in the way it judges safety standards for embryonic-stem-cell therapies. The FDA is reviewing other stem-cell-based technologies, but embryonic stem cells are prized because they can regenerate quickly and act like almost any other cell in the body.
"There is now enough of a critical mass to have this meeting," said FDA spokeswoman Karen Riley.
Concerns remain that embryonic stem cells can trigger benign tumors called teratomas.
"There's always an issue for the FDA with novel technologies" on how to evaluate safety, said Celia Witten, director of the agency's office of cellular, tissue and gene therapy.
One of the most-critical problems the FDA must tackle is how to determine the length of time for a stem-cell trial in animals before proceeding to human testing, Dr. Witten said.
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