By Lisa Seachrist

Washington Editor

WASHINGTON — In the wake of Chicago physicist Richard Seed's plan to clone a human being and President Clinton's call for legislation to ban cloning, the Biotechnology Industry Organization (BIO) urged Health and Human Services Secretary Donna Shalala to assert the FDA's regulatory authority and jurisdiction over any attempt to clone a human being.

In a letter to Shalala dated Jan. 13, BIO's president, Carl Feldbaum, called on the secretary to employ existing regulations to issue a clinical hold on all cloning attempts.

"This represents an interesting and innovative approach to a very pressing problem," Feldbaum said. "Hopefully, it will give us a bit of breathing room before Congress starts in earnest."

BIO's missive seems likely to find a receptive audience at the agency.

An FDA source told BioWorld Today that "not only does the agency believe it has the authority to regulate attempts at human cloning, it is prepared to do so with a view toward protecting the public health."

Feldbaum noted in his letter that "the Food and Drug Administration has broad authority to regulate biologic products. Last February, FDA published a regulatory framework for the regulation of cellular and tissue-based products."

That framework calls on the agency to regulate tissue based on the degree of manipulation of cells and tissues. Feldbaum claimed in the letter that "Dr. Seed's proposal to clone humans using nuclear transfer technology is much more than minimal manipulation as the original function of the egg cell is unmistakably altered by the removal of the parental haploid DNA and insertion of DNA from a somatic cell from another person."

As a result, Feldbaum argued, attempts to clone a human being fall under FDA's jurisdiction, requiring all such attempts to undergo regulatory review, including investigational new drug (IND) applications and license review regulations.

The FDA not only regulates tissues and manipulated cells, but has the authority to regulate nucleic acid used in humans and regulates many of the medical devices that would be used to produce a human clone. A source at the agency said the FDA is prepared to use the tissue and biologics regulations to assert its authority to review any protocols that attempt to clone a human being.

In deciding whether to approve any cloning IND, the agency would seek to ensure that preclinical and animal data were sufficient to indicate the safety and efficacy of the procedure. The FDA could issue clinical holds on protocols, disqualify investigators who make attempts in spite of a clinical hold, or go to the courts to enjoin such individuals from cloning a human being.

Because neither the safety nor efficacy of cloning has yet been shown in animals — it took 276 attempts to produce an apparently healthy sheep-clone — Feldbaum called on the secretary to issue a clinical hold on any IND submission to proceed with such experiments.

"This approach could give lawmakers breathing space to consider the legislation that they are introducing," Feldbaum said. "At the same time, asserting FDA's authority over human cloning will protect biomedical research."

Congress Likely To Join The Fray

Congress will likely join this latest cloning fray when members return Jan. 27 for the next session. Rep. Vernon Ehlers (R-Mich.), who has introduced two bills to ban cloning and the federal funding of cloning, said in a written statement Wednesday that he would urge his colleagues to pass the bill quickly.

"As a scientist, I recognize full well that there are times in history when there are experiments that science can do but should not do," said Ehlers, who holds a Ph.D. in nuclear physics. "Society as a whole has to make this judgment, and the governmental process is the way society makes those decisions."

Last year's furor over "Dolly" not only led Ehlers and Sen. Christopher Bond (R-Mo.) to produce anti-cloning legislation, but prompted President Clinton to charge his newly formed National Bioethics Advisory Commission (NBAC) to preempt their agenda and make recommendations on the ethics of cloning a human being within 90 days.

After the June release of the NBAC report suggesting that the president seek a legislative ban, Clinton sent his own legislation to Congress, though no one as yet has sponsored it.

While there has been some legislative activity since "Dolly" was unveiled, Feldbaum expects that Seed's cloning plans will accelerate efforts to make the procedure illegal. The problem for the biotechnology industry is that all efforts to date have flaws that could inadvertently impede legitimate research endeavors.

Feldbaum said that if the FDA asserts its authority, lawmakers could have enough time to craft legislation that would protect biomedical research. That appears to be a goal for Ehlers as well.

"We cannot entirely close the door on the science of cloning," Ehlers said. "It is important that we continue to explore and experiment with various non-human subjects to learn all we can about this new development, but it is imperative that scientists refrain from crossing the line into research on cloning humans. I am pleased that the National Bioethics Advisory Commission agrees with me, and after three months of serious discussion urged Congress to pass a ban on human cloning." *

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