FDA’s 2007 budget: Will it be enough? GPhA doesn’t think so.

The FDA recently released its proposed budget for Fiscal Year 2007, requesting a 3.8% increase over last year. In drug-manufacturing-related areas, the Agency has called for over $30 million to fund pandemic preparedness efforts, $5.9 million for the Critical Path initiative, as well as $6.4 million for medical product safety. For a brief summary of the proposed budget, click here. For a very detailed look at the numbers, click here. The Generic Pharmaceutical Association's President and CEO, Kathleen Jaeger, says that the budget is inadequate, and that funding for the Office of Generics should have increased. Workload at the Office has increased by 36%, and there is already a backlog of over 800 generic drug applications to review. The situation should only get worse, she says, since $100 billion in brand-name drugs are scheduled to come off patent by 2010. To access her official response to FDA's proposed budget, click here. -AMS