If President Obama gets his way on the FDA, the agency would see its federal funding rise by 6 percent to $2.51 billion. That means, together with user fees, the agency would have a total budget of $4 billion, allowing it to staff up by 1,251 additional full-time workers and fund a major expansion of its food-safety capabilities. A large chunk of it would fund regulation of tobacco.
The additional money would also be used to a.) Speed up review of generics, to get copycat drugs on the market sooner; b.) Review generic biologic drugs; and c.) Boost the safety of medical products, and the availability of data on their use. Some $100 million would be earmarked for safety initiatives; $25 million would be used to beef up FDA's science capabilities.
The FDA has been pumping up on the funding side for the last couple of years, after a long dry spell when budgets either shrank or stagnated. The push for additional drug-safety funding gathered steam after a series of snafus exposed vast holes in the agency's inspection coverage, particularly overseas. And the agency's own Science Board lambasted its scientific expertise and equipment. No word yet on just how much of the new budget would be funneled to international inspections and overseas FDA offices.