Everyone seems to be talking about “patients” these days. It’s the word du jour. The drug industry says patients are their reason for being in business. National disease advocacy groups represent the voices of their “patients.” And the recent reauthorization of PDUFA V includes a new FDA initiative called Patient-Focused Drug Development which will involve patient engagement earlier in the drug development process. The FDA will work with patient communities on unmet needs and treatments as well as determine accepted levels of risk.
One the one hand it sounds like a great idea to hear from patients, but who are the patient stakeholders that pharma and the FDA are talking to? Are they mainly the industry funded astroturf groups and patients with serious, life-threatening diseases who are in favor of getting more drugs approved more quickly and say they’re willing to accept more risk? Our conference will be critically exploring the role and definitions of “patients” as well as getting different perspectives from consumers, physicians, and scientists on risk assessment.