The Food and Drug Administration has made the decision to effectuate two provisions of the user fee law in hopes to amplify the voice of the patient in the process of drug development. This action will surely be celebrated by many patient groups and disease advocacy organizations that have been lobbying for these provisions. FDA is developing a list of 20 disease categories that will be publicly available for comment until November 1, and FDA will hold a meeting for public commentary October 25, 2012 from 9am to 12:30pm. To post comments with FDA, click here. Those disease areas chosen will serve as the focal points for upcoming meetings to help FDA capture the voice of the patient as they weigh risk vs. benefit in therapeutic development.
One important aspect FDA is trying to improve is the lack of acceptable treatment options for those suffering from some serious diseases. With increased emphasis on the patient drug development effort, FDA is striving to shift focus away from doctors and more towards patients.
FDA is also searching for eager patients and patient advocacy organizations to participate in consultative meetings focused on the patient in FDA decisions. Interested groups must contact FDA by the end of this month.
To read about future FDA notices on PDUFA V in upcoming months, check back here at the Pearl blog for updates.