The primary focus of my topic is three fold, first if a high ranking
official from a firm were to become the Director of an agency and his former
company is asking for approval of a drug, how should the Director act in regard
to this rulemaking? The second question is not a difficult, if a former Director
were to assume a position at a firm asking for approval of a drug, how should
the former directors position influence the decisions of the agency? Finally how
could government regulation limit the potential conflicts of interest from the
The first scenario answer is both ethics and law based. It would be
unethical for the Director to have any influence what so ever in this
circumstance. Realistically the Director would have probably at least an
influence to the degree that those who work for him would at least try and guess
his desire for the outcome, at worst he would directly or indirectly tell them.
Probably at this point no procedural rules have been breached. This is of course
only if the director has not tried to influence the Administrative Law Judge in
which case many legal issues could be raised, more on that in question three.
Back to the ethics involved, it would be very important if the Director were to
try and be ethical about the issue he/she should give the appearance of ethical
procedure. One way this could be done is that a recommendation could be made
rulemaking be in a formal format. In addition she/he should be very careful to
limit ex parte contacts between himself and his former business associates.
Under no circumstance should the Director have conversation of any nature
involving this case. Under the circumstance that the drug was or was not
approved, the case could go before Judicial review, there any appearance of
unethical behavior could not only be be evidence to support a plaintiffs claims,
and even case a de novo review, but even worst it could be food for the media
and a public... [continues]
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