February 16, 2006

The FDA would cut funding to some generic drug programs, including generic drug research and information processing modernization, in fiscal 2007 as part of a plan to shift $52.3 million from existing programs to priority initiatives, including drug safety and influenza pandemic preparedness.

The proposed fiscal 2007 funding for the Office of Generic Drugs (OGD) is nearly flat at $29.1 million, compared to $28.3 million in 2006, according to the FDA budget blueprint released recently.

The flat funding comes as OGD faces a backlog of generic drug applications. The OGD estimates the average review time for abbreviated new drug applications (ANDAs) will increase to 17.5 months, up from 16.9 months in 2006 and 16.3 months in 2005. The number of ANDAs rose 36 percent to 766 in 2005, but the number of ANDA approvals rose only 13 percent to 467, OGD said.

The Generic Pharmaceutical Association (GPhA) said it was "extremely disappointed" in the budget proposal. "This is the third fiscal year in a row that OGD's budget has been flat-funded," said GPhA president and CEO Kathleen Jaeger. "Although funding for OGD was increased slightly in fiscal year 2003, the funds were not expressly earmarked for specific day-to-day operations on generic applications. As a result, most of the funds went to other agency initiatives."