The last day of the Generic Pharmaceutical Association (“GPhA”) 2013 Annual Meeting also featured an FDA Keynote Address by FDA Commissioner Margaret A. Hamburg, M.D. For a summary of public sessions from Day Two, please see the previous blog here; a summary of the CEOs Unplugged session may be found here.
Following the CEOs Unplugged session on day three, Hamburg delivered her Keynote Address. Hamburg said that GPhA was one of the few organizations that she has chosen to address each year since becoming Commissioner, “because of the dynamic character of this group, your prominent role in the nation’s health care system and the importance of the work you do.” Celebrating GDUFA and the FDA Safety and Innovation Act (“FDASIA”), Hamburg emphasized that FDA is making “quality one of the highest priorities this year,” hoping that GPhA’s members do the same. Despite generic drug companies providing 85 percent of all prescriptions filled, some studies have suggested that many physicians still have “negative perceptions about the quality of generic medicines,” which Hamburg said was “troublesome – and assuredly not fair.”
Hamburg reported “impressive strides in implementing GDUFA,” explaining that FDA got the word out of new requirements and fees early, resulting in the collection of almost $125 million in fiscal year 2013 user fees to help brining in staff and other resources to help reduce the backlog of ANDAs above 2,500 applications with median review times at about 31 months. FDA has assembled a list of about 2,000 facilities supplying generic drugs to the U.S. following self-identification procedures.