Q & A with FDA's Gary Buehler

April 2, 2007

At the Generic Pharmaceutical Association meeting in Phoenix last month, Drug Topics' Managing Editor of Projects, Anthony Vecchione, spoke with Gary Buehler, R. Ph., Director, Office of Generic Drugs.

DT: Does the Office of Generic Drugs have sufficient manpower to process new generic drug applications?

Buehler: Everybody would like to have more personnel. We got almost 800 applications last year, and we were able to approve or tentatively approve somewhat over 500. We have a gap of almost 300 applications. And as long as that gap exists, the backlog is going to continue to increase. I would like to close the gap. I would like to have a situation where the amount of work that comes in would be equal to the amount of work that goes out. That would mean, for me, increasing approvals and tentative approvals from, right now, a little over 40 per month to somewhere around 70 a month. Congress is concerned about our backlog, and we have provided figures to them on how we could address the backlog. We believe we will need to be able to hire 20 to 30 full-time equivalents [FTEs] per year in the next three to four years. We should be able to come close to that hiring goal with the funds appropriated for FY 2007. The FY 2008 process is just starting on Capitol Hill, so we'll have to see how it comes out.

Buehler: Realistically, user fees would be one way to provide additional resources. We have been working with appropriated funds.

DT: Do you have enough money in the budget to meet your goals?

Buehler: I'm hopeful that we can reach our goal. In the 2008 budget the President has proposed $15 million-$10 million through user fees and $5 million through appropriated funds. But the appropriations process has just begun. We have also had $5 million appropriated for the remainder of FY '07. That would be enough to be able to hire the people. We can no longer just add one or two people here or there to be able to close the gap that we need to close; we have to be able to add one or two teams or another division. And we need some larger work units rather than just individuals. In 2006 we received more than 1,700 letters that have to be responded to individually. It's a tremendous workload for us.

DT: What has been the impact of citizen petitions?

Buehler: I'm not sure how many we had last year. But they are a significant resource drain. There are a number of resources dedicated to them by my office and by the Office of Chief Counsel and the Office of Regulatory Policy that respond to them. Many times the Office of New Drugs had to give an opinion on some of the challenges. It's difficult to make it a fast process. There has to be a lot of agreement, a lot of coordination between the different components of the agency, so that we can come up with what is an agency response.