. The challenges of human cloning for public policy in Illinois. Human cloning; Human cloning; Human cloning; Public Policy. being, but it does assert jurisdiction over human cloning experiments. According to the FDA, clinical research on creating a human using cloning technology would require the same approval process as an investigational new drug (IND). The agency has further stated that it "will ensure that such experimentation does not proceed until basic ques- tions about safety are ;21 The IND approval process entails a rigorous, multi-step review with continuing over
. The challenges of human cloning for public policy in Illinois. Human cloning; Human cloning; Human cloning; Public Policy. being, but it does assert jurisdiction over human cloning experiments. According to the FDA, clinical research on creating a human using cloning technology would require the same approval process as an investigational new drug (IND). The agency has further stated that it "will ensure that such experimentation does not proceed until basic ques- tions about safety are ;21 The IND approval process entails a rigorous, multi-step review with continuing oversight. Even after granting approval, the FDA could delay or suspend a clinical investigation at any time if it finds that "[h]uman subjects are or would be exposed to an unreasonable and signifi- cant risk of illness or ;22 Under the FDA's authority, anyone who proceeded with human cloning without FDA ap- proval would be subject to civil and/or criminal sanctions. In order for the FDA to exercise this authority over human cloning, a clone or the SNT process would need to fit within the definition of a "biological product" under the Public Health Service Act, or a "drug" or "medical device" under the Food, Drug and Cosmetics Act. One legal commenta- tor has questioned whether human cloning fits into any of these classifica- tions when used for procreative purposes rather than disease prevention or But the FDA has not had to exercise its regulatory authority, and so its scope remains untested. Constitutional limitations Even without preemptive federal legislation or action by the Food and Drug Administration, state regulation of SNT could be limited by rights conferred in the Constitution. One potential limit is a right to conduct Another is a right to procreate. Although neither right has been recognized by the Supreme Court to date, either one could conceivably be created in an appropriate case as an ex
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