Peter Pitts, Center for Medicine in the Public Interest president, was an FDA associate commissioner
Risk management means more than REMS strategies and tactics, more than validated methodologies and therapeutic registries. It's not about the management of risk—it's about assuming the mantle of responsibility.
Risk management can't just be about doing what's necessary to get a product approved. In the social-media age, accepting the responsibility of risk means that we must stop being translucent and start being transparent. It's more than just doing what we're told, of being in compliance. Because we know better.
The responsibility of risk is shared. It must be more than what the FDA expects from industry and more than what industry expects from the FDA. It's what all parties to the public health conversation must expect from themselves.
“The fault, dear Brutus, is not in our stars, but in ourselves.”
The responsibility of risk means doing what's in the best interest of the patient fully and completely and beyond what is required—even when it is contrary to short term sales and marketing objectives. When we let profit or politics trump what's in the best interest of the public health, we might as well be selling air conditioners.
Principles, as my father taught me, don't count until they hurt.
The responsibility of risk means appreciating and actualizing the philosophy of the safe use of drugs. For example, the responsibility of risk means not just detailing—but detailing the label.
And the responsibility of risk is global. Acknowledging the responsibility of risk means embracing the urgency for harmonized global pharmacovigilence.
Other than that, it's easy and straightforward.