FDA Hearings To Examine Regulation Of Embryonic Stem Cell Treatments

Main Category: Stem Cell Research
Also Included In: Regulatory Affairs / Drug Approvals;  Women's Health / Gynecology
Article Date: 11 Apr 2008 - 5:00 PDT

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FDA on Thursday will begin two days of hearings to examine how the agency will regulate human embryonic stem cell therapies, the Wall Street Journal reports. Executives from biotechnology companies, investors, researchers and representatives from patient advocacy groups are expected to attend the hearings, according to FDA officials.

According to the Journal, biotech leaders and investors are seeking more certainty about FDA guidelines for approval of treatments derived from embryonic stem cells and want to ensure that FDA is not averse to approving such treatments for "political reasons." One company involved in the hearings, Menlo Park, Calif.-based Genron, expects to file an FDA application this summer to begin human testing of a therapy to repair acute spinal injury, the Journal reports. White House spokesperson Tony Fratto said that the Bush administration allows treatments derived from stem cell research and that he is not aware of any objections to the FDA moving forward to approve such treatments despite President Bush's restrictions on embryonic stem cell research funding (Mundy, Wall Street Journal, 4/10). Federal funding for embryonic stem cell research is allowed only for research using embryonic stem cell lines created on or before Aug. 9, 2001, under a policy announced by Bush on that date. Bush twice has vetoed bills that would have allowed federal funding for research using stem cells derived from human embryos originally created for fertility treatments and willingly donated by patients (Daily Women's Health Policy Report, 1/29).

Some biotech leaders are concerned that FDA is being pressured into establishing approval guidelines too quickly because there are still concerns regarding ethics, efficacy and safety of the research. There also are concerns that embryonic stem cells could trigger benign tumors. According to Celia Witten, director of FDA's office of cellular, tissue and gene therapy, one of the agency's most critical problems will be determining how long such treatments must be tested in animals before entering human trials.

Richard Garr -- CEO of Neuralstem, which develops adult stem cell products -- said FDA is "nervous" and under "tremendous pressure." He added that the agency cannot "appear adversarial but they can't seem to be rolling over for industry either." Witten said that there is "always an issue" regarding evaluation of safety of "novel technologies" for the agency (Wall Street Journal, 4/10).

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