This is of courseonly if the director has not tried to influence the Administrative Law Judge inwhich 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 totry and be ethical about the issue he/she should give the appearance of ethicalprocedure. One way this could be done is that a recommendation could be maderulemaking be in a formal format. In addition she/he should be very careful tolimit ex parte contacts between himself and his former business associates. Under no circumstance should the Director have conversation of any natureinvolving this case. Under the circumstance that the drug was or was notapproved, the case could go before Judicial review, there any appearance ofunethical 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 mediaand a public scandal.
The second question if the director were to leave and become a superiorfor a firm. I don’t see this as a big threat, the new director would have hisnew alliances. It would seem like any influence that the former director wouldhave would have to be kept to a minimum in order to preserve the rulemakingunder the circumstance that the findings were on the firms behalf. As a companyrepresentative he should not personally make ex parte contacts with the agencyand obviously not approach the ALJ. The government control over the behavior described above is done throughvarious ways. The first way is to keep the final decision maker in regard to theagencies findings, the ALJ, separate from the mainstream agency.
The is inaccordance with the procedural rules as outlined in the Administrative ProcedureAct (APA). The situation of ex parte contacts or meetings which are off therecord are a problem. They are primarily demonstrated in the format of informalrulemaking, so it would be a good policy to make high profile cases goodsituations to place on the formal rulemaking track. Another controllinginfluence is the three acts which impose public scrutiny of the agenciesbehavior during rulemaking. The freedom of information act, the government isresponsible to disclose specific records to the public on request.
TheGovernment in Sunshine Act, here every portion of every meeting that is headedby a collegial body is open to public observation. The Regulatory FlexibilityAct of 1980, If a new regulation has a significant influence on small businessan 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 lesspower 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 toprotect society from insider manipulations but I feel in truth it is common andfor the most part because of the power of Agencies not preventable. It isperhaps the constant attention that is paid to the Federal Register by Publicgroups and environmentalists which protect us the most.