Leadership Changes at FDA

Gary Buehler, the director of the FDA’s Office of Generic Drugs, has changed positions at the agency and will now serve in the Office of Pharmaceutical Science, which oversees the generics area. Mr. Buehler led the generics office for 10 years. Keith Webber, the deputy director of the Office of Pharmaceutical Science, will take over for Mr. Buehler on an interim basis.

According to information presented by the FDA at the Generic Pharmaceutical Association convention last month, Mr. Buehler’s division has a backlog of 2,000 generic-drug applications, with more than 500 additional applications anticipated by the end of this year.

Also, concerns were expressed at the meeting about the two-year-plus waiting time for FDA approval and the costs in lost sales. It was also suggested that, like branded pharmaceutical companies, generic drug companies should pay user fees to help cover the cost of FDA reviews.

FDA Commissioner Margaret Hamburg stated at the conference that she endorses user fees and will work with the administration to get them into legislation. The amount of the fees and whether they could be applied to reduce the current backlog remains unclear.