FDA science base badly eroded: but will congress provide urgent new funding?

new Reagan–Udall Foundation to raise private money to fund the FDA’s Critical Path Initiative. Dr. Woodcock had promoted this initiative, but the FDA has essentially put it on hold since 2004 for lack of funds. The FDAAA authorized $1.25 million in fiscal year 2008 from FDA funds marked for administrative startup to get the Foundation up and running before it had a chance to solicit the private funds on which it will have to depend in the future. However, Representative Rosa DeLauro (D-Conn.), Chairperson of the House Appropriations Subcommittee with the authority to determine the FDA budget, inserted a provision in the FDA appro priations bill for 2008 prohibiting the use of agency funds for the Foundation, which has been paralyzed as a result. However, that did not prevent Ms. DeLauro from issuing a press release after President Bush published his federal budget proposal for fiscal 2009 on February 5. The budget proposed to increase the CDER budget from $680.3 million in fiscal 2008 to $738.7 million in fiscal 2009, a 7.8% increase. Of that $68 million increase, $26 million would come from increased drug company user fees—that money is dedicated to new drug review activities. The rest would ostensibly come from a higher congressional appropriation. But that extra money would be spent on many CDER activities. It is not clear from the President’s budget how much of the $42 million extra for CDER in 2009 would go for “science” investments or—more importantly—whether Congress would provide the extra $42 million. There is no mention in the FDA’s narrative that accompanies the 2009 budget proposal of any new investments in science, much less the Reagan–Udall Foundation.