Congress considering cloning legislation

Members of Congress on Wednesday challenged FDA's assertion that it has the legal authority and resources to regulate human cloning, and said they may introduce legislation to prohibit cloning. Speaking at a hearing on cloning, Rep. Billy Tauzin (R-La.), chairman of the House Energy and Commerce Committee, said he is very interested in enacting legislation to ban human cloning. He said FDA's claims that it can regulate and prohibit human cloning experiments by classifying them as "cellular therapies" are "tenuous" and are unlikely to withstand a legal challenge. "FDA says it can regulate human cloning because the agency has interpreted old federal laws to cover new cloning activities. The FDA argues these old federal laws regulating new drugs cover a human cell or a human fetus. I frankly do not find it obvious that a human fetus is a drug," Tauzin said. In addition, Tauzin said "FDA's authority is based only on safety concerns, not on the ethical or moral concerns. That leaves open the question whether the FDA would permit cloning a human being if it were satisfied on the safety concerns. The Congress may need to pass legislation to ban human cloning or take other actions to firm up FDA's policies or grant enforcement authority to another agency." Kathryn Zoon, director of FDA's Center for Biologics Evaluation and Research, acknowledged that if a sponsor could demonstrate that human cloning was safe, current laws would not allow FDA to prohibit the practice on moral or ethical grounds.

Several other members of Congress expressed strong opposition to human cloning, expressed support for legislation to ban the practice, and said that care should be taken to ensure that such legislation does not inhibit legitimate research. ...