SECTION: CAPITOL HILL HEARING TESTIMONY

LENGTH: 800 words

COMMITTEE: HOUSE ENERGY AND COMMERCE

HEADLINE: TESTIMONY OVERSIGNT OF HUMAN CLONING RESEARCH

TESTIMONY-BY: KATHRYN C. ZOON

AFFILIATION: FOOD AND DRUG ADMINISTRATION

BODY:
March 28,2001 Summary of Testimony of Kathryn C. Zoon Food and Drug Administration FDA views the use of cloning technology to clone a human being as a cause for public health concern. Because of unresolved safety questions, on the use of cloning technology to clone a human being, FDA would not permit the use of cloning technology to clone a human being at this time. There have been numerous press articles on individuals and groups expressing interest in cloning a human being by cloning technology. We have heard that people have incorrectly stated that there are no legal controls in place in the United States governing the use of cloning technology to clone a human being. FDA's role in assessing the use of cloning technology to clone a human being is a scientific one. FDA has the authority to regulate medical products, including biological products, drugs, and devices. The use of cloning technology to clone a human being would be subject to both the biologics provisions of the Public Health Service (PHS) Act and the drug and device provisions of the Federal Food, Drug, and Cosmetic (FD&C) Act. Before such clinical research could begin, the -researcher must submit an R- ,1D request to FDA, which FDA would review to determine if such research could proceed. FDA believes that there are major unresolved safety questions on the use of cloning technology to clone a human being and therefore would not permit any such investigation to proceed at this time. The technology used to clone Dolly, the sheep, did not readily result in the birth of a lamb cloned from an adult sheep. It took 276 failed attempts before Dolly was born. Since the time of Dolly, additional animals have been cloned. However, the success rate remains low and numerous abnormalities in the offspring and safety risks to the mother have been observed. These facts raise serious concerns regarding the use of cloning technology to clone a human being. In 1998, FDA notified professional organizations, Institutional Review Boards, and several individuals professing an interest in using somatic cell nuclear transfer to clone a human being. The letter notified researchers that clinical research could proceed only when an IND is in effect. The letter stated that until significant safety issues are appropriately addressed, FDA would not permit any such investigation to proceed. Since 1998, circumstances have not changed to warrant a change in FDA's position. We can assure you that the Agency will continue to inform such individuals and entities of the laws and regulations governing such research and take appropriate enforcement action as warranted to protect the health and safety of the public.

LOAD-DATE: March 30, 2001, Friday