According to CDER Office of New Drugs Director John Jenkins, a crucial piece it creating a risk/benefit assessment model is the patient perspective.
"I think it's very important to understand the patients' perspective about how they value the benefits and how they are willing to accept the risk," Jenkins said.
Jenkins continues, "A lot of us are basing these decisions in the abstract. We don't have the disease, we haven't achieved the benefit, and we do not actually have to weigh, personally, that benefit against the risk."
And further, "Regulators and others may not consider those benefits to be very important, but to the patients, they are extremely important and allowed them to go on about their lives.”
Providing people with different therapeutic options is another important aspect of risk-benefit assessment, Jenkins said. "We at FDA consider having a range of choices available to be a very important aspect in the practice of medicine." Even though a drug may not be a best in class, he noted, it may still be the best choice for an individual patient.
There also are various societal expectations about "how we should interpret and apply the standard," he said. He gave the example of when FDA was first criticized for being too slow in approving drugs, and later criticized for being too fast in drug approval, and now it is once again criticized for being too slow.
"So as regulators we have to be aware of the societal expectations of how we interpret our standard and how we make our decisions.”
John Jenkins taking about “societal expectations” within the context of new drug review?
Bravo.
