CLONING INFORMATION

Letter to Tommy Thompson Requesting the FDA Look Into Advanced Cell Technology's Actions Related to Cloning

Christian Legal Society

VIA FACSIMILE
AND REGULAR MAIL

Tommy G. Thompson, Secretary
U.S. Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, DC 20201

Re: Advanced Cell Technology's Reported Creation of Human Embryos Through Cloning

Dear Secretary Thompson:

The purpose of this letter is to ask that you instruct the Food and Drug Administration (FDA) to determine whether Advanced Cell Technology, Inc. (ACT), violated federal law by creating human embryos through cloning technology.

FDA has repeatedly asserted its regulatory jurisdiction over human cloning. In March of this year, Kathryn C. Zoon, Ph.D., Director of FDA's Center for Biologics Evaluation and Research (CBER), submitted testimony to a congressional committee in which she declared that:

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.

In that same testimony, Dr. Zoon made clear the consequences of that regulatory authority:

Before such research could begin, the researcher must submit an IND request to FDA, which FDA would review to determine if such research could proceed.

Dr. Zoon also explained how FDA would respond to such a request:

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.

Given that ACT did perform the research in question, it appears as though only two scenarios are possible: (1) ACT did not seek FDA's prior approval; and (2) ACT sought and received FDA's prior approval. Given Dr. Zoon's statements regarding how FDA would respond to a request for an IND, the second scenario is extremely unlikely.

Therefore, one can plausibly assume that ACT failed to seek the arguably necessary approval from FDA before pursuing its cloning activities. It is our understanding that the relevant statutes authorize FDA to investigate this situation and to pursue sanctions or other remedial measures.

If that understanding is correct, we respectfully request that you instruct FDA to exercise its regulatory authority with respect to ACT's past and intended cloning activities.

Very truly yours,


Gregory S. Baylor

cc: Claude A. Allen [Deputy Secretary of HHS]
     Alex Azar [General Counsel of HHS]
     Daniel Troy [General Counsel, FDA]
     Rachel Brand [White House, Assistant Counsel to the President]