The Food and Drug Administration has decided it has the authority to regulate human cloning, and agency officials warned yesterday that it would be a violation of federal law to try the procedure without its approval.
"Through the Food, Drug and Cosmetic Act we do have the authority to regulate human cloning, and we are prepared to assert that authority," acting FDA Commissioner Michael A. Friedman said in an interview.
The unambiguous declaration by FDA officials confirmed what the agency and Health and Human Services Secretary Donna E. Shalala have hinted at since a Chicago-area scientist announced last month that he would try to clone a person: Human cloning is a form of cellular or genetic therapy that requires prior approval by FDA reviewers.
That means anyone who wants to attempt human cloning legally must file a formal application with the FDA, which would then undertake a lengthy review, Friedman said. The FDA will initiate legal action against anyone who fails to file that application, he said.
President Clinton banned the use of federal funds for human cloning research last March, after scientists in Scotland announced they had cloned an adult sheep. But legislation to ban privately funded human cloning research stalled in Congress last session. And public fears that someone might try the feat flared anew when Illinois scientist G. Richard Seed announced he would try to clone a person before Congress enacted a ban.
After reviewing the issue for several weeks, Friedman yesterday said the FDA had determined that the kinds of manipulations involved in human cloning presented "serious health and safety issues" for the fetus and the mother.
Another FDA official, speaking on the condition of anonymity, said would-be cloners would have to go through a formal procedure that includes the filing of an "investigational new drug application" (IND), which is what drug companies must submit when they want to test new medicines on people.
The IND process requires researchers to prove to the satisfaction of the FDA that their proposed experiment does not pose unreasonable risk of harm to human subjects -- a task that currently would be difficult for human cloning, given the overwhelming failure rate in animal cloning experiments. "They will have to answer questions like, `Have you established animal models? Can you improve the odds? Have you looked at safer alternatives?' " the official said.
Moreover, the official said, given the controversy surrounding the issue of human cloning, the agency might require public hearings as it did last year while it was considering how to regulate the transplantation of animal organs into people.
"It should be done in the open," the official said. "Going through the FDA regulatory pathways, everyone has a say and we face our fears in public and discuss them."
Seed said last night he would have to think about whether to challenge the FDA's legal interpretation, or simply move his cloning effort offshore, as he has said he would do if Congress tried to interfere with his plans. "I'm going to have to talk with a lawyer," he said. "I'd have to evaluate on what basis they're saying this -- what clause of which law."
The FDA officials' comments came amid mounting pressure from scientific organizations that the agency make a clear statement about its regulatory authority over cloning, and as an increasing number of congressional representatives announced they would introduce legislation to ban human cloning.
Scientific groups have become concerned that some of the bills aimed at preventing human cloning would inadvertently or intentionally preclude other kinds of research. A plain statement about the FDA's authority over cloning might take some pressure off Congress, sources inside and outside the administration said, and allow legislators time to craft more carefully worded legislation.
A bill proposed by President Clinton and supported by various scientific organizations has failed to gain any sponsors.
The one bill that has already been approved by the House Science Committee, sponsored by Rep. Vernon Ehlers (R-Mich.), would ban not only human cloning but also human embryo research -- a controversial arena of research that for years has been mired in the debate over abortion.
Federal funding for human embryo research has been banned in this country on an annual basis since 1994 through appropriations language imposed by Congress. But the Ehlers bill would codify that ban as law and make it much more difficult to reverse -- a situation that concerns scientists who believe that studies of human embryos could lead to breakthroughs in fertility, genetics and cancer.
"We think the issue of cloning a human being is a critical and distinct issue, and it's wrong to steer it into the political maelstrom of the abortion debate," said Carl Feldbaum, president of the Washington-based Biotechnology Industry Organization, which represents about 750 biotechnology and academic research institutes and supports a carefully worded ban on human cloning. "The abortion debate, frankly, will not be settled in 1998 or '99," Feldbaum said, "while the issue of cloning human beings deserves to be resolved, and can be."
Last week, Feldbaum sent an open letter to Shalala encouraging her to assert HHS's authority over cloning in the hope that Congress would not rush into a broad research ban. In yesterday's edition of BioCentury, a San Carlos, Calif.-based biotechnology industry newsletter, Philip D. Noguchi, director of the FDA's division of cellular and gene therapies, said for the first time that the agency had firmly decided that human cloning involves "more than minimal manipulation" of human cells. That standard, known in FDA parlance as MTMM, has great meaning within the agency: It is the dividing line between human tissue experiments that do and do not require prior approval from the FDA.
Meanwhile, last week, Rep. Cliff Stearns (R-Fla.) joined the growing list of congressmen who have announced they would submit legislation to ban human cloning. That could delay action on the Ehlers bill, since Stearns heads the Commerce Committee that was the Ehlers bill's next stop. Sen. Dianne Feinstein (D-Calif.) said Friday she too would submit human cloning legislation, the first Democrat to do so.