Activities
Gary Buehler Reports on Issues Hampering Generic Drug Reviews at March Luncheon
Attendees of the FDA Alumni Association's luncheon on March 5, 2009 in Rockville, MD were very grateful to Mr. Gary Buehler, Director of the Office of Generic Drugs (OGD) for generously giving his time to speak to the Association's membership. Mr. Buehler's main message was that OGD is understaffed relative to the growth in its review workload. He offered insight into OGD's increasing workloads and the Office's work on Citizens Petitions since the Food and Drug Administration Amendments Act (FDAAA) was signed into law in 2007. He punctuated the talk by informing the group that generic industry leaders expect that by 2012, 80% of prescriptions that will be filled will be for generics, as compared to 69.3% prescriptions filled in 2008.
Mr. Buehler argued for additional resources, citing the following:
- OGD staff has grown from 140 to 265 in the last four years, while the numbers of his Office's applications have tripled.
- Over the past four years, Mr. Buehler's Office has logged in 800 applications per year. Four hundred and fifty to 650 applications were approved during the last four years. The average time for the completion of a review of an application to his Office is currently 21.5 months.
- The Office currently has a backlog of 1600 applications, although all of these have received an initial review.
Mr. Buehler's Office, and the Agency overall, are taking the foreign imports/foreign inspections issue(s) very seriously, as these raise many concerns. He used the heparin sourcing issue as an example of one of the Agency's biggest challenges, because foreign sourcing remains an oversight problem. Mr. Buehler pointed out that the Agency's new offices in China and India are a first step to addressing these issues.
Regarding the efficacy of anti-seizure generic medications, Mr. Buehler indicated that the Agency has been working with the American Epilepsy Society to address this issue.
Submitted: Brenda Seidman, Ph.D.