Final Report (all chapters)

the women involved. Using PGD for non-therapeutic purposes raises a host of ethical issues, and
should be strongly discouraged by the regulatory system.
Biomedical research involving early-stage embryos or blastocysts. We believe that
medical research on embryos or blastocysts is important and legitimate, but that it ought to be
done under carefully controlled circumstances, given the intermediate moral status of embryos.
This means that the regulatory authority ought to monitor and control the creation and transfer of
all embryos used for these purposes, much as the British HFEA does currently. This kind of
regulatory capacity will also be necessary in order to enforce any reproductive cloning ban.
Commercialization of elements of human reproduction. We believe that the buying and
selling of human embryos should be strictly regulated, again, given their intermediate moral
status. We believe that embryos can be used for research purposes and that a limited market
should be allowed to develop to facilitate their transfer (for example, excess embryos from ART
clinics), but that all such transfers should be carefully tracked by the regulatory authority.
3 The Current Legislative and Regulatory Framework
3.1 Federal Regulators
Human biomedicine is and has for a long time been one of the most heavily regulated areas
of endeavor in the United States. The FDA’s “gold standard” of costly, double-blind clinical
trials for pharmaceuticals is unmatched anywhere the world. On the other hand, the FDA
regulates only drugs, medical devices, and biological products (or “biologics”), and can regulate
them only on the basis of safety and efficacy. It does not directly regulate the practice of
medicine, which means that the large area of medicine involving assisted reproductive
technologies receives virtually no direct federal government oversight. While the FDA strictly
enforces testing procedures for new drugs, it does not control their off-label uses, meaning that
doctors are free to innovate and in effect experiment on their patients in such cases.
The other big regulatory institution in the United States is the National Institutes of Health
(NIH), which through its control over federal funding exerts enormous control over the nature,
scope, and direction of scientific research in biomedicine. It is the NIH that now oversees bodies
like the Recombinant DNA Advisory Committee (RAC), and requires institutional review boards
(IRBs) to monitor research involving human subjects. The NIH is not limited to considerations
of safety and efficacy like the FDA; it can and has introduced moral and ethical concerns into its
decision-making. President Bush’s August 2001 decision limiting federally funded stem cell
research to existing stem cell lines reflected his concerns over protecting embryos, and was
implemented by the NIH. Here, the limits of regulatory authority are different than in the case of
the FDA. The NIH can influence science only through its control of funding; it cannot prohibit
privately funded research, and it has no say over what happens in the private biotech industry.
In addition to the statutes governing the FDA and the NIH, there are other federal statutes
relevant to assisted reproduction, including the Clinical Laboratory Improvement Amendments
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