Business and Government Agencies
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 scandal.
The second question if the director were to leave and become a superior
for a firm. I don’t see this as a big threat, the new director would have his
new alliances. It would seem like any influence that the former director would
have would have to be kept to a minimum in order to preserve the rulemaking
under the circumstance that the findings were on the firms behalf. As a company
representative he should not personally make ex parte contacts with the agency
and obviously not approach the ALJ.
The government control over the behavior described above is done through
various ways. The first way is to keep the final decision maker in regard to the
agencies findings, the ALJ, separate from the mainstream agency. The is in
accordance with the procedural rules as outlined in the Administrative Procedure
Act (APA). The situation of ex parte contacts or meetings which are off the
record are a problem. They are primarily demonstrated in the format of informal
rulemaking, so it would be a good policy to make high profile cases good
situations to place on the formal rulemaking track. Another controlling
influence is the three acts which impose public scrutiny of the agencies
behavior during rulemaking. The freedom of information act, the government is
responsible to disclose specific records to the public on request. The
Government in Sunshine Act, here every portion of every meeting that is headed
by a collegial body is open to public observation. The Regulatory Flexibility
Act of 1980, If a new regulation has a significant influence on small business
an analysis is done to determine if the financial burden out weighs the benefits.
If so then less costly alternatives are given.
The two cases of the Director are extreme, in truth individuals of less
power but sometimes more influence to the actual findings, for example an ALJ,
may be a more common occurrence. The government has went to some lengths to
protect society from insider manipulations but I feel in truth it is common and
for the most part because of the power of Agencies not preventable. It is
perhaps the constant attention that is paid to the Federal Register by Public
groups and environmentalists which protect us the most.