Citing “significant improvements” that have already been made in the FDA’s Office of Generic Drugs, deputy commissioner for medical and scientific affairs Scott Gottlieb, MD, today told the Generic Pharmaceutical Association (GPhA) that the agency could “always do more with more.” Meeting in Boca Raton, Fla., GPhA attendees heard Gottlieb detail progress in clearing a backlog of hundreds of Abbreviated New Drug Applications, which have been the subject of recent news reports and agency criticisms.

“I want to start by saying at the outset that I reject the recent criticism of our budget at FDA, and by that I mean those who call into question our commitment to the generic approval process,” Gottlieb emphasized. “The fact is since [fiscal year] 2001, the budget of the Office of Generic Drugs has doubled and during this time the overall number of full time personnel has increased from 143 to the present level of 201. In 2005 alone, 12 employees were added and we plan to add more in 2006."

However, Gottlieb sought to enlist the generics industry in helping to improve the situation, “It's clear we cannot continue to improve our generic drug program alone. We will also need the help of the generic drug industry. For example, we must continue to work together to make sure that the quality of generic applications continues to improve so that more of them can be reviewed and approved on the first cycle. And we must work together to develop the scientific base for making generic versions available for inhaled medicines, or dermatological agents, where some of the science for demonstrating equivalency still needs to be developed.”

Source: http://www.pharmacist.com