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Disagreement arises over whether FDA has role in human cloning

WASHINGTON (BP)–The head of the Food and Drug
Administration has said his agency holds the power to
regulate human cloning, but the White House, a Michigan
congressman and a Southern Baptist ethicist say legislation
is still needed to prevent the experimental practice.
In the wake of Chicago scientist Richard Seed’s
announcement he plans to clone a human being in 18 months,
FDA Acting Commissioner Michael Friedman said his agency has the authority to control such an attempt and is “prepared to assert that authority,” The Washington Post reported Jan. 20.
Anyone who seeks to clone a person must go through a
formal application process with the FDA, which will begin a
review of the request, Friedman told The Post. If someone
attempts human cloning without filing an application, the
FDA will instigate legal action, he said.
There is disagreement, however, over whether the FDA
has jurisdiction over human cloning, The New York Times
reported Jan. 21.
Officials of the Biotechnology Industry Organization
and the Pharmaceutical Manufacturers Association of America
said they oppose human cloning but believe the federal
government agency, not Congress, should regulate it,
according to The Times. “The FDA’s assertion of jurisdiction
would make legislation redundant,” BIO President Carl
Feldbaum told The Times. BIO represents about 750 companies
and institutes.
Some specialists in food and drug law, as well as a
congressman who is seeking to ban human cloning, question
that assertion, The Times reported.
“It’s hard to argue that a cloning procedure is a
drug,” Rep. Vernon Ehlers, R.-Mich., told The Times. “It is
certainly open to question.”
Ehlers, who has introduced bills banning federal
funding of human cloning as well as the practice itself,
said a legislative ban is needed because “regulatory action
can be reversed anytime the regulatory agency changes its
philosophy,” The Times reported.
The White House expressed agreement with Ehlers’
strategy. Spokesman Barry Toiv told The Times, “We believe
that it is important to enact legislation, and we’re going
to pursue it.”
A congressional ban “would preclude” this type of
confusion, Southern Baptist bioethics specialist Ben
Mitchell told Baptist Press.
“Congress needs to grab this hot potato now so that
we’re not tossing it around a year from now while people
like Richard Seed are playing with human genes like they’re
some kind of biological erector set,” said Mitchell,
assistant professor of Christian ethics at Southern Baptist
Theological Seminary, Louisville, Ky.
Both BIO and the pharmaceutical manufacturers “want to
hold open the possibility that cloning a human being might
be acceptable in a few years,” Mitchell said. “That’s why
they want the FDA to regulate cloning. Congress and the
president need to send a clear message to the world that
human beings should not and will not be cloned.
“Furthermore, the FDA has no jurisdiction outside the
United States, and we need a worldwide ban. For the law to
have teeth, there will have to be legislation and criminal
penalties attached to cloning humans. Nothing less will do,”
said Mitchell, who also is a consultant with the SBC’s
Ethics & Religious Liberty Commission.
President Clinton had called last year for a five-year
ban on human cloning in legislation he sent to Congress on
recommendation from the National Bioethics Advisory
Commission. Congress did not act on the measure or Ehlers’
bills during 1997. When Seed’s announced attempt was
publicized in early January of this year, the president
reiterated his call for support of his bill.
Mitchell described Clinton’s proposal as inadequate,
saying an indefinite ban was needed and calling for the
president to work with multinational organizations to
initiate a worldwide ban.
Seed told The Post he did not know if he would
challenge the FDA’s interpretation of its authority or
switch his cloning project outside the country. If Congress
bans human cloning, he has said he plans to move his project
to a location such as Tijuana, Mexico; the Cayman Islands;
or the Bahamas.
Seed first revealed his plans at a scientific meeting
in early December at Chicago, but they did not become well
known until news reports beginning Jan. 6.
Nineteen European countries signed a treaty Jan. 12
opposing human cloning and committing them to adopt laws
banning the practice. England did not sign the treaty
because it considered the agreement too strict, and Germany
withheld its endorsement because it did not consider the
treaty tough enough.
Messengers to the 1997 Southern Baptist Convention
meeting adopted a resolution calling on Congress to ban all
research on human embryos, as well as the cloning of human
beings. The resolution also urged Congress to push for an
international policy to prohibit human cloning worldwide.
In March last year, Clinton issued an executive order
prohibiting the use of federal funds for human cloning and
calling for a voluntary moratorium on private research. The
president’s action followed the Feb. 22 announcement that
Scottish researchers had cloned the first adult mammal, a
sheep named Dolly. Since that breakthrough, concern about
the possibility of human cloning has multiplied.