Real-Life Decision Making
"Don't expect to be loved," says Joseph Arcarese. He is the executive vice-president of the Food, Drug, and Law Institute in Washington, D.C.
Arcarese says you sometimes have to tell the marketing people that something is not possible. Or you might have to tell the company that compliance is going to take more money or staff than they thought.
"Meanwhile," says Arcarese, "the company might be running out of venture capital funds, waiting for the market clearance of this new product so that they can begin selling it and getting some revenue."
Regulatory affairs professionals have a huge responsibility to the public and their company! After all, their decisions could mean the difference between life and death.
You are a regulatory affairs associate for Get Well Drugs. You are researching their newest product. More than a dozen studies were done. One of them indicates that the drug might cause side effects in elderly patients with reduced kidney function.
When the CEO of your company hears the news, he and your supervisor call you in for a little discussion.
The CEO says, "We think it might be best that you not share your study results with the Food and Drug Administration (FDA)."
How could he suggest such a thing? Regulations require that you submit the study to the FDA. You remind them of this.
They still insist that you withhold your study. Your supervisor says, "After all, this report might lead to a significant reduction in the sale of this drug. That would mean less profit for our company! Get my point?"
What do you do?