By Jonathan W. Emord
Emord Blog at Emord.com
On occasion, when executives of an FDA regulated company face the potential for civil or criminal prosecution, they think members of Congress potential allies. While they are undoubtedly correct that the decision to devote government resources for prosecution is invariably a political one, they are ordinarily incorrect in their assumption that politicians will rescue them. There are at least four reasons why members of Congress will not exercise their power to help a company under investigation.
First, it is an error to presume that members of Congress or their staffs will perceive the problem faced by a regulatee in the same way that the regulatee perceives it. Having little or no knowledge of the regulatee, most members are suspicious of the regulatee’s motives. Even if sympathetic, most will feel constrained to avoid involvement in a matter that might be headed for enforcement. The most horrific turn occurs when the regulatee is ignorant of the members’ views and happens to complain to a member who favors the FDA and may even have urged the FDA to increase its prosecution of parties that are precisely in the same position as the complaining regulatee. In that circumstance, it is not uncommon for the regulatee to be invited to pour out the otherwise privileged details concerning the event. Then, while the member writes some ambiguous letter to the regulatee pledging to look into the matter and alert the proper authorities, the member or his or her staff actually divulges to the FDA the regulatee’s confidences, which may include admissions against interest. The result will be a hastening of regulatory enforcement and, likely, a loss of the attorney-client privilege or the Fifth Amendment privilege against self-incrimination.
Second, savvy members and their staffs avoid any involvement in matters that might evolve into a civil or criminal suit because actions they take may be considered in aid of an unlawful enterprise and representations they make if substantive in defense of the company may be viewed as an attempt to abuse congressional power. Of paramount significance to the member is the risk that in the end the matter may become public with the regulatee revealed to have been culpable for acts that caused injury. Evidence of a member’s actions to obstruct the investigation or to dissuade political appointees from pursuing it would then redound to the member’s political detriment.
Third, most members are versed in giving lip service to constituents while making few tangible commitments and expending very little political capital in aid of them. A complaining regulatee who is a constituent may be glad handled by the member or his staff and believe that help is on the way only to discover that the most the member will do is write a rather sheepish letter of inquiry to the agency, asking that the constituent’s concerns be addressed. Those kind of generic letters are understood by the agency to reveal a lack of dedicated interest on the part of the member and to be a means to placate a constituent for political reasons. Such letters either go unanswered or receive vague pat responses from FDA that are of no use and have no effect on the agency’s predisposition to act against a regulatee.
Fourth, if a serious set of questions are posed by a member, particularly a ranking member or one on a committee with oversight over the agency (House Commerce Committee or Senate Health Committee), the FDA may feel compelled to alert several within the agency having jurisdiction over the matter to evaluate the matter in issue and thus to raise that matter’s visibility within the agency. At FDA, that leads to a fear of potential scapegoating by underlings in charge of an investigation. That fear, in turn, causes the investigation to be pursued with more vigor to ferret out more facts that support internally recommended actions and thereby diminish the risk of scapegoating.
In short, more times than not, sending a letter or email to a member of Congress to complain about mistreatment by the FDA is a mistake. When the matter has become public and there is a plain failure by those charged with responsibility within the agency to act lawfully or reasonably, it may be wise to complain, but in such circumstances it is often better in the first instance that the complaint come from a credible source who is not the target of the investigation.