In the human cloning debate, virtually everyone agrees on one point: the need to protect children and women from undue risk. Any children produced through cloning, as well as women supplying oocytes and gestating cloned embryos and fetuses, would be part of an experiment. These individuals ought to receive the same protections as other human research subjects.
Oversight by the Food and Drug Administration (FDA) would be essential to providing such protections. The Federal Policy for the Protection of Human Subjects, also known as the Common Rule, applies to investigators at institutions receiving federal research funds. Regulations issued by the FDA extend the Common Rule's basic requirements to private sponsors conducting human drug, device, and biological product testing. Without FDA oversight, cloning researchers at infertility centers or other facilities unaffiliated with federally funded institutions would be free to disregard federal requirements for informed consent, reasonable risk-expected benefit ratios, equitable subject selection, and Institutional Review Board (IRB) evaluation.
Officials at the FDA claim that existing law gives the agency jurisdiction to regulate private-sector efforts to produce children through cloning. They have announced their intent to apply to cloning the same requirements they apply to unapproved drugs. In a 1998 letter to IRBs, Associate Commissioner Stuart Nightingale declared that cloning research sponsors would be required: "to submit to FDA an [investigational new drug application] describing the proposed research plan; to obtain authorization from a properly constituted and functioning IRB; and to obtain a commitment from the investigators to obtain informed consent from all human subjects of the research." (1) In 2001, the head of the FDA's Center for Biologics Evaluation and Research told a congressional subcommittee that the agency would regulate human cloning and that safety issues would prevent the agency from approving human cloning attempts at this time. There are also reports that FDA officials have warned specific researchers that they would face penalties for trying to clone a child.
Yet legal scholars, as well as some members of Congress, wonder whether the FDA actually has the authority it claims. They are far from certain that the federal laws empowering FDA to regulate medical products extend to human cloning procedures. And even if the statutory language can be stretched to accommodate cloning, they say, the agency's summary action in this case may have violated administrative law requirements designed to promote fair and rational public policy.
Strained Statutory Construction
Statutory language presents one difficulty for FDA officials. Administrative agencies are constrained by the terms of their authorizing legislation. Congress has given the FDA power to oversee the development and marketing of medical products. The requirements Dr. Nightingale described govern the human testing of certain unapproved medical products, including new drugs, some investigational devices, and biological products that qualify as drugs.
According to FDA officials, cloning may be regulated as a biological product. The Public Health Service Act defines biological product as "any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product ... applicable to the prevention, treatment, or cure of diseases or injuries of man." (2) A second definition is also relevant to FDA oversight of human cloning studies. For biological products to be covered by the FDA's human research regulations, the products must also fit the laws drug definition. (3) The law defines drugs as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and ... articles ... intended to affect the structure or function of the body of man or other animal. …