Efforts to Ban Human Cloning May Not Hold Up, Legal Scholars Warn

WASHINGTON The letter from the Food and Drug Administration got right to the point. "You are receiving this letter because in media reports and on your Web site you have expressed an intention to pursue the creation of a human being using cloning technology," it said. Human cloning is "subject to FDA regulation," the letter warned. "You should be aware that failure to comply with FDA regulatory requirements may lead to enforcement action."

The March 23 letter went to Brigitte Boisselier, scientific director of an obscure religious group that has said it will clone a dead child, and to Panos Zavos, a Kentucky scientist who recently said that he, too, intends to clone someone. But they both say the federal agency is bluffing, and they are not alone. Many legal scholars say they find little evidence to support the agency's assertion of authority over cloning. They maintain that food and drug laws provide no legal basis for stopping doctors from trying to clone a person, and that if the agency tried to do so it would lose in court.

Moreover, the prime alternative to regulation by the agency - a congressional ban on human cloning - may be just as untenable. The six anti-cloning bills pending before Congress are entangled in the politics of abortion. Some legal scholars suspect that even if a ban were to pass in Congress, it might be struck down as unconstitutional because it would abridge the fundamental right to procreate. That could mean there is little to stop anyone in the United States from pursuing human cloning. It also suggests that the prospect of human cloning could push the Supreme Court to tackle one of the toughest reproductive rights issues since Roe v. Wade legalized abortion on demand in 1973: whether there are limits to the number of ways a person can legally reproduce.

"Can the government really stop me from cloning myself?" asked Alta Charo, a University of Wisconsin law professor. Right now, she said, the law is "clear as mud." The Food and Drug Administration has asserted otherwise since 1998, saying that although it has no authority over how doctors practice medicine, it does have authority over human cloning.

"Based on our legal analysis, we feel very confident that our jurisdiction is appropriate," said Kathryn Zoon, director of the agency's Center for Biologics Evaluation and Research, who signed the letters to Ms. Boisselier and Mr. Zavos. Ms. Zoon says that authority comes in part from the Public Health Service Act, which gives the agency the power to regulate "biological products" that are used to treat medical conditions. "Biological product" is defined as "any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component" or "analogous product." A cloned human embryo is a "biological product" intended to treat a condition, Ms. Zoon says - most notably infertility. Lars Noah, a University of Florida professor who specializes in food and drug law, calls that "a remarkable claim" that goes well beyond any reasonable interpretation of the law. Besides, he and others asked, would that mean that the agency would not have authority over people who clone themselves for other reasons, such as narcissism?

"It's an undefendable position," said Elizabeth Foley, a law professor at the Detroit College of Law, who has written scholarly articles on human cloning and the law. "It shows that their assertion of jurisdiction is really a stretch."

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"Researchers feel that FDA will be more reasonable about this than Congress is going to be," Mr. Noah said. But regulation by the Food and Drug Administration will not satisfy some opponents of human cloning. For one thing, the agency is legally bound to consider only objective concerns like safety and efficacy, not moral issues. That means that if human cloning were shown to be safe and effective, the agency would be obliged to allow the research.

Moreover - and here is where the abortion debate comes in - the agency is obliged to protect the consumer of cloned embryos, not the embryos themselves, which it sees as mere drugs. It has no regulatory qualms about scientists creating and destroying cloned human embryos to obtain embryonic stem cells, for example, which have the potential to cure many diseases. But for people who believe that life begins at conception, that research is tantamount to murder.

The strongest constitutional argument against a ban on human cloning comes from Supreme Court references to human reproduction as a "fundamental right" so "deeply rooted" that the government cannot abridge it unless it can show a truly compelling interest. Even then, the court has said, restrictions on fundamental rights must be tailored as narrowly as possible to address specific and objective concerns. The court has said that "procreation" and the right "to have offspring" are fundamental rights. In 1971 it said: "If the right to privacy means anything," it is the right "to be free from unwarranted governmental intrusion into matters so fundamentally affecting a person as the decision whether to bear or beget a child."

If the Supreme Court were to hear a challenge to a human cloning ban, it would have to decide whether those statements apply to this new kind of reproduction.
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