Question

Jessica Smith is the vice president of new drug development at Generic Phama, Inc, a pharmaceutical research company in Boston, Massachusetts. One year ago, she filed an application with the Food and Drug Administration (FDA) to obtain approval of a new drug for treating cancer. Smith met Joe Spencer at a convention three months ago and invited him to her room at the hotel. The two parted ways. Spencer worked as the director for approval of new drugs at the FDA. Two weeks later, Spencer wrote Smith a letter on FDA letterhead stating, “It was nice to see your name cross my desk on our company’s application for approval of the new cancer drug. I’d really like to see you again. Why don’t you come visit me in Washington this weekend?”

Smith considered requesting that the petition be referred to another director at the FDA. However, she is concerned that the transfer would delay the approval process for at least a year. Smith’s chief scientist advised her that a key competitor plans to introduce a similar drug on the market in three months.

Are there any legal or ethical barriers to relationships between corporate officers and members of administrative agencies involved in reviewing or regulating corporate activity?

What should she do?   

What would you advise her to do if you were head of human resources or legal counsel for Generic Pharma, Inc.

Answer 1

Yes, there are legal and ethical barriers to relationships between corporate officers and members of administrative agencies involved in reviewing or regulating corporate activity because relationships may actually affect the decision of the department based on the statement of a member of the administrative agency so legally the relationship should not be used in the process of approval and ethically also this is not right because this is kind of a preference or bias that is created.

At present she cannot do anything rather than wait of the decision and if the decision is not as per what she expects and if she believes that it is because of the relationship that they possess then she should actually work this up to the higher management of FDA for clarification of the rejection.

As the head of HR I would have actually advised her not to reply to Joe Spencer and keep the message as a document for the time being and anything from him should be saved which my actually be used if the application is rejected based on the relationship. These documents can then be used as proof against Joe.