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

Published on Thursday, May 24, 2001 in the International Herald Tribune
by Rick Weiss

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."

The agency also says it can regulate human cloning under the Food, Drug
and Cosmetic Act, because, it says, cloned human embryos are "drugs."
That act defines drugs as "articles (other than food) intended to affect the
structure or any function of the body." According to the agency, a cloned
human embryo is an "article" that affects the structure and function of a
woman's body by making her pregnant. But several experts dismissed that
interpretation.

"Congress is not going to buy that an embryo is an article or a drug," said
George Annas, a Boston University law professor, noting that many in
Congress believe embryos are fully entitled human beings. Curiously, the
only vocal support for the agency's claim to authority over cloning has come
from those who stand to be regulated by the agency as they work with cloned
cells and human embryos.

"We looked into this very seriously and have determined that the FDA does
have clear and far-reaching authority to regulate efforts to clone human beings,"
said Carl Feldbaum, head of the Biotechnology Industry Organization,
representing nearly 1,000 biotechnology companies.

When it comes to oversight by the Food and Drug Administration or
Congress, the agency is seen as the lesser of two evils.

"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.