The FDA Steps In

http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm150508.htm

In October, 1998 the US Food and Drug Administration sent out a letter regarding human cloning (link above). Because of the successful creation of Dolly, a cloned mammal, and the seemingly rapid developments in cloning technology that followed, people were becoming increasingly worried about the possibility of someone creating a human clone. Many scientists and lay-people alike had realized, in the wake of Dolly's creation, that the world was not ready for this influx of new technologies. Perhaps scientific communities had accepted cloning as a possibility, but they expected advances to take at least 5-10 more years. Now, Roslin Institute was making leaps and bounds, and others were sure to follow. So several urgent questions arose: Would a scientist create a human clone? Should there be any regulations imposed on cloning technologies? Who should be allowed or not allowed to try and create a human clone? Was cloning even ethical to begin with? Should we allow cloning of animals, even?

More than a year after the birth of Dolly, the FDA stepped in. The FDA sent letters out, stating their claim to regulate human cloning.
I quote: "The purpose of this letter is to confirm to institutional review boards (IRBs) that the Food and Drug Administration (FDA) has jurisdiction over clinical research using cloning technology to create a human being.... This letter is being sent to IRBs at this time because of reports in the media that scientists are contemplating the use of cloning technology to create human beings...

"Clinical research using cloning technology to create a human being is subject to FDA regulation under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act. Under these statutes and FDA's implementing regulations, before such research may begin, the sponsor of the research is required to submit to FDA an IND 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.... Since FDA believes that there are major unresolved safety questions pertaining to the use of cloning technology to create a human being, until those questions are appropriately addressed in the IND, FDA would not permit any such investigation to proceed."

The public, and here, the US government, were slightly scared of this new technology, with unknown and maybe limitless potential. Cloning was viewed as somewhat of a threat, and the FDA essentially forbade scientists from pursuing human reproductive cloning without explicit governmental permission.

We will explore whether anything has changed in the past 10-12 years. Is cloning still seen as dangerous by the public? Does the FDA still enforce such strict regulations? How has the FDA gone about regulating other types of cloning, such as gene cloning?

C. Heard