FDA to Regulate Cloning

Deciding that it "has the authority to regulate human cloning," the Food and Drug Administration yesterday warned that "it would be a violation of federal law to try the procedure without its approval," The Washington Post reports.

According to FDA Acting Commissioner Michael Friedman, the agency has the authority to regulate cloning under the Food, Drug and Cosmetic Act. The Post reports that this "unambiguous declaration ... confirmed" what the FDA and Health and Human Services Secretary Donna Shalala "have hinted at" ever since a Chicago physicist announced plans earlier this month to open a human cloning clinic. Since that time, both Shalala and the FDA have suggested that the procedure requires FDA approval since it "is a form of cellular or genetic therapy."

Yesterday's FDA declaration "means anyone who wants to attempt human cloning legally must file a formal application with the FDA, which would then undertake a lengthy review," said Friedman. The agency "will initiate legal action against" persons who fail to comply.

Researchers wanting to perform the procedure would have to "prove to the satisfaction of the FDA that their proposed experiment does not pose unreasonable risk of harm to human subjects," said another FDA official. The Post notes that these requirements would be "difficult ... given the overwhelming failure rate in animal cloning experiments." In addition, the "controversy" surrounding the issue may push the FDA to "require public hearings" when evaluating each human cloning proposal. The FDA's human cloning announcement "might take some pressure off Congress ... and allow legislators time to craft more carefully worded legislation," said "sources inside and outside the agency."

A bill proposed by President Clinton, with support from several scientific groups, still "has failed to gain any sponsors." Another bill, sponsored by Rep. Vernon Ehlers (R-MI) to "ban not only human cloning but also human embryo research," has been approved by the House Science Committee.

In addition, Sen. Diane Feinstein (D-CA) said late last week that she would submit a bill to ban human cloning. Feinstein's bill would prohibit public and privately funded human cloning for ten years. It would also require the National Bioethics Advisory Commission to report to the president and Congress on the state of the science of somatic cell nuclear transfer, the ethical and social issues associated with the potential use of this technology in humans and the advisability of continuing the prohibition established by the bill.