Final Report (all chapters)

eaching out to the public, the agencies hoped to obtain additional information, new insights and
data that could strengthen the cases for their respective new rules, a goal that closely parallels
our call for the consideration of a much broader range of normative arguments in contemporary
bioethical debates. The agencies did not expect notice-and-comment to produce exclusively
supportive arguments, and organized interest groups did use notice-and-comment to register their
discontent. But as hoped for by the agencies, the number of favorable comments dwarfed the
negative reactions, thus strengthening the agencies’ positions.
Critics could argue that these agencies manipulated the rule-making process to achieve their
own bureaucratic goals, and that the process just described is a blatant case of “rogue” agency
behavior, of agency “drift.” This criticism is misleading. For one thing, the goals pursued by all
three agencies were indeed largely in the interest of the general public. Pursuing broader
objectives certainly has not benefited the leadership of these agencies. To the contrary, by
deciding to fight powerful business interests and their allies in Congress, these agencies took
significant risks. The agencies simply used the room afforded to them by the APA to discharge
their public mandate, and did so in the same way well-organized private groups routinely do to
pursue their own interests.
That the agencies succeeded in neutralizing the distorting effect of organized interest groups
demonstrates that regulators genuinely committed to pursuing broader societal interests can use
notice-and-comment to their advantage. Unfortunately, these are the proverbial exceptions to the
rule. Mounting an effective outreach campaign is a time-consuming and costly undertaking that
many agencies may not be able to undertake. The APA certainly does not mandate conducting
costly and time-consuming outreach campaigns. Deciding to fight large business interests and
Congress at the same time is not a decision many administrators are likely to make. Nor are
senior administrators inclined to risk a conflict with the president. In sum, notice-and-comment,
by itself, is of very limited value as a tool of public involvement. It can, however, become quite
useful in combination with other measures of public outreach.
10.4 Why Consult with the Public?
In section 10.1, we argued that untangling modern bioethical dilemmas will likely require
devising institutions of public consultation of a novel kind. We argued that the inclusion of the
general public in policy-making would prevent political failures, or at least mitigate political
distortions in a policy arena fraught with both. Another way to account for the importance of
adopting robust institutions of public consultation is to note that the quality of a policy and the
fairness of the decision-making process crucially depend on the range of views available to
decision-makers. Skeptics may agree with this general observation but observe that in the case of
biomedical dilemmas, the general public simply does not have the expertise to make substantial
contributions to the debate. In this section, we discuss a few examples that demonstrate the
opposite. Taken together, they suggest that professional views of ethical dilemmas represent only
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