Washington Editor

WASHINGTON - The FDA's legal authority to regulate human and therapeutic cloning under current law is being questioned by a group of presidential advisers.

While no one suggested that the FDA should lack such authority, the President's Council on Bioethics spent two hours here Friday morning discussing the FDA's role in advancing science, particularly related to biotechnology and the future of cloning.

"The question is, Does the FDA have the authority it has claimed.' If it does, the law has to be on the books prior to the birth of Dolly [the cloned sheep] because there have been no new laws applying to this since the birth," Richard Merrill, a law professor at the University of Virginia in Charlottesville, told council members. "The word cloning' does not appear in any statute."

President Bush appointed the 18-member bioethics council in August 2001 following his decision to allow the National Institutes of Health to fund research on 64 (now 72) existing stem cell lines. Headed by Leon Kass, a professor at the University of Chicago, the council's role is to advise the president on moral and ethical issues of advancing science.

Indeed, the council has spent much of its time discussing policy related to therapeutic and human cloning, even voting last summer to recommend (10-7) a four-year moratorium on therapeutic cloning. (See BioWorld Today, July 12, 2002.)

The issue of human cloning became front-page news again around Christmas when the group Clonaid, of Montreal, claimed it cloned a baby named Eve. A few weeks later, the group said it had assisted a lesbian couple in bearing a clone. (See BioWorld Today, Jan. 9, 2003.)

Merrill told council members the FDA believes it has authority over cloning via its right to regulate research in clinical trials. In other words, the agency could stop a cloning project by refusing to grant approval of a clinical trial by citing safety or efficacy concerns.

When asked by council members whether the FDA is competent to make moral decisions as part of its normal function, James Benson, a former acting FDA commissioner, said that's not the FDA's job.

"I don't think the FDA should have to make moral decisions," he said. "Usually they don't because they get direction from Congress."

If the FDA were challenged in court over its authority to regulate cloning, Merrill said he's not sure who would win. "I can't say whether the agency would win or lose because they haven't put their best foot forward on this and proven their case," he said.

Furthermore, "the agency would have been wiser if it had asserted its statutory authority over cloning in the Federal Registry and allowed the public to comment on it."

All pending legislation related to human or therapeutic cloning died at the end of the 107th Congress in December. Two days into the 108th Congress, Reps. Dave Weldon (R-Fla.) and Bart Stupak (D-Mich.) introduced the Human Cloning Prohibition Act, legislation that would criminalize both reproductive and therapeutic cloning. (The same legislation, authored by Weldon, passed in a House vote of 265-162 in August 2001.)

In related news, a Gallup poll conducted Jan. 3-5 showed that 11 percent of Americans believe reproductive cloning should be legal, while 86 percent say it should be outlawed. Comparatively, in a similar poll conducted in May 2002, 8 percent of respondents said they would support human cloning. Also, 51 percent of respondents favored cloning human cells from adults for medical use and 59 percent supported cloning organs or body parts for use in transplants.

The next meeting of the President's Council on Bioethics is scheduled March 6 and 7 in Washington. Kass intends to invite an expert in assisted reproduction to discuss how it is regulated. For more information on the council, visit the website, www.bioethics.gov.