The Food and Drug Administration’s Oversight of Human Cloning Technology

In 1996, Dolly the sheep became the first large animal cloned from a bioengineered embryo that had been implanted in a ewe’s womb. It took 277 attempts before a viable lamb was born. Other animals have been cloned to date, but successful cloning has not occurred often and various abnormalities have been seen. In 1999, it was reported that DNA had been found in Dolly’s cells which was typical of an older animal.

FDA Authority over Human Cloning

Under the Federal Food, Drug, and Cosmetic Act (FDCA), the Food and Drug Administration (FDA) has authority to regulate food, drugs, medical devices, and cosmetics. The Public Health Service Act (PHSA), which was passed by Congress in 1999, gives the FDA additional regulatory authority over biological products. Under the PHSA, the FDA can approve, suspend, and revoke biologics licenses that have been issued to companies. The FDA has authority to regulate human cloning technology under both the PHSA and the FDCA.

FDA Final Rule on Human Cloning

In January 2001, the FDA issued a final rule for the regulation of human cells and tissues. The rule states that all studies involving human cloning have to get pre-approval from the FDA. Therefore, companies that want to perform clinical research using cloning technology must submit a biological Investigational New Drug Application (INDA) to the FDA for approval. The approval process works as follows: The research sponsor submits an INDA describing the proposed research. The company is also required to get the approval of an Institutional Review Board (IRB), which is a committee composed of scientists, medical advisors, and consumers. The IRB’s role is to protect study participants. In addition, the company must fully inform study participants of the potential risks and benefits and get their consent to participate in the study. The FDA has refused to permit clinical research using cloning technology for the purpose of cloning a human being, citing significant safety issues about cloning technology.

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