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additional discussion.33 The changed vote took many Council members by surprise, and some on the Council believe that the moratorium option, as opposed to a ban, was thrown in at the last minute and did not receive adequate discussion. In addition, some on the Council believe that the widely reported final vote of 10 to 7 in favor of a moratorium does not accurately reflect the fact “that the majority of the council has no problem with the ethics of biomedical cloning.”34 The final report, Human Cloning and Human Dignity: An Ethical Inquiry, was released on July 11, 2002.

In March 2001, the FDA sent letters to the research community stating that the creation of a human being using cloning is subject to FDA regulation under the Public Health Service Act and the Food, Drug and Cosmetic Act.35 FDA stated that such research could only occur when an investigational new drug application (IND) is in effect. Some legal scholars believe that there is no legal basis for the regulation of cloning by FDA.36 They find little evidence to support FDA’s position that cloned human embryos are “drugs.” However, the biotechnologyindustryand the American Society for Reproductive Medicine believe FDA has the authority to regulate cloning and legislation is unnecessary because FDA regulation is preferred to any new action by Congress.37

On January 18, 2002, the National Academies released its report, entitled

Scientific and recommended

Medical that the

Aspects of Human Reproductive Cloning.38 U.S. ban human reproductive cloning. The

The panel panel was

concerned for the safety of to be too dangerous for use

both the woman and the fetus in humans at the present time.

and The

judged the procedure ban should be legally

enforceable, rather than voluntary, and carry substantial be reconsidered in five years, but only if compelling new

penalties. The ban should data on safety and efficacy

are

presented

and

a

national

dialogue

on

the

social

and

ethical

issues

suggests

that

a

review

is

warranted.

However,

the

panel

concluded

that

research

using

SCNT

to

produce

stem

cells

should

be

permitted

because

of

the

considerable

potential

for

developing new agreement with

therapies and advancing biomedical knowledge. This position is in a previous National Academies’ report entitled Stem Cells and the

Future

of

Regenerative

Medicine,

which

was

released

on

September

11,

2001.39

33

Ibid., p. 324.

34

Ibid., p. 322.

35 The FDA position statement and letters to the research community are available at [http://www.fda.gov/cber/genetherapy/clone.htm].

36 R. Weiss, “Legal Barriers to Human Cloning May Not Hold Up,” Washington Post, May 23, 2001, p. A1.

37

Ibid.

38 The National Academies are the National Academy of Sciences, the National Academy of Engineering, the Institute of Medicine, and the National Research Council. The report on human cloning is available at [http://www.nap.edu/catalog/10285.html?onpi_topnews_ 011802].

39 The National Academies’ report on stem cell research is available at [http://www.nap.edu/ catalog/10195.html?onpi_topnews_091101].

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