FDA to Investigate Clonaid

WASHINGTON – The Food and Drug Administration will probe whether a sect claiming to have produced the world's first human clone illegally performed any of the alleged work in the United States, a senior agency official said Friday.

The nation has no specific law against human cloning. But the FDA, which regulates human experiments, has contended since 1998 that its regulations forbid human cloning without prior agency permission -- permission it has no intention of giving.

Clonaid, a company formed by a group called the Raelians who claim aliens created all life on Earth, announced that it had produced a cloned baby girl born Thursday to a U.S. woman -- although it provided no proof that the baby had indeed been cloned.

Nor would company head Brigitte Boisselier say where the human embryo allegedly was cloned or implanted into the mother, or even where the baby was born.

FDA investigators will promptly contact Clonaid to see "where did the implantation take place. That's the fundamental question," said a high-ranking agency official, speaking on condition of anonymity. "The implantation of a cloned baby into a woman is, we think, illegal in the United States without FDA approval because of fundamental safety and ethical concerns."

Just what steps the FDA would take aren't yet clear, the official said, because just what Clonaid did -- and when and where -- so far are shrouded in secrecy.

But if Clonaid performed all of its alleged work abroad and the baby merely was born here, the FDA likely would have no grounds to intervene against the company.

Indeed, even if the FDA decided Clonaid performed illegal experiments here, its authority to intervene is in question. Some members of Congress have pushed for a law explicitly banning human cloning by saying FDA's jurisdiction is shaky, and the Bush administration is pushing for such a ban, too.

"The president believes, like most Americans, that human cloning is deeply troubling," said White House spokesman Scott McClellan. "Despite the widespread skepticism among scientists and medical professionals about today's announcement, it underscores the need for the new Congress to act ... to ban all human cloning."

Last year, the House passed a bill, backed by Bush, that would ban all forms of human cloning. But the Senate sought to draw a distinction between cloning for baby-making and the cloning of human embryonic cells for medical research -- and the legislation ended in a stalemate.

Lawmakers expressed skepticism that Clonaid had indeed produced a clone. Nevertheless, Friday's announcement sparked calls by conservatives to renew the push for a total cloning ban.

"While I am skeptical about today's report, this points to the need for Congress to enact a permanent and comprehensive ban on human cloning when we return," said Sen. Sam Brownback, R-Kan., who pledged to reintroduce legislation.

Privately, some Democrats worried that the Clonaid uproar, whether it proves true or a hoax, would harm their efforts to continue legal research with cloned embryonic stem cells.

Clonaid, among other groups, claims to have a list of couples waiting to either give birth or be implanted with a cloned embryo.

The FDA warned Friday that such experiments are too risky to be tried in people yet. For example, even if cloning did work, an egg donated from someone with hepatitis or the AIDS virus likely would infect any resulting baby and the mother, too, said FDA biotechnology chief Dr. Phil Noguchi.

"There's a variety of unknown things that could happen," he said. "This was too dangerous to proceed at this time."