WASHINGTON—In mid-July, the U.S. Senate's Agriculture Appropriations Subcommittee proposed increasing the FDA's budget for 2008 by $186 million, which includes a $33.2 million boost for the Critical Path Initiative and drug safety measures. The Subcommittee's bill, led by Chairman Herbert Kohl (D-WI) and Ranking Member Robert Bennett (R-UT) is $122 million above President Bush's budget request for the FDA and significantly above the House Appropriation Committee's own proposal—which increases the budget by $128.5 million compared to 2007 levels. Moreover, if the Senate bill ends up being the final word or close to it, that would be the most significant increase in the FDA's budget in recent memory, notes Jim Greenwood, president and CEO of the Biotechnology Industry Organization.
But question marks remain, because the Senate proposal isn't the last word. The bill still has to go to full committee, and then on to the floor of the Senate, where it could still be voted down or watered down, notes William Hubbard, a former FDA associate commissioner and now an advisor to The Coalition for a Stronger FDA.
"We also don't know the full details about where specifically the money would go in terms of Critical Path and drug safety," Hubbard notes, "and we won't until the subcommittee's final report is issued and the bill moves on through the process."
Hubbard notes that there is a high likelihood that one or more problematic amendments will be attached to the bill, such as something involving importation of drugs from Canada. "That particular amendment has been an issue for five or six straight years, and will likely come up again this year, and it could affect the timing of the bill," he says. "They probably won't get to a final action on this until at least September."
But he says that Bennett and Kohl do seem keenly aware of the importance of increased funding for drug safety and the Critical Path Initiative. That being said, Kohl seems to be stressing the food-related aspects of the proposed FDA budget increase to his constituency, but Wisconsin does have a sizable food, beverage and agriculture base. Bennett, on the other hand, is being fairly vocal about the drug side of the equation.
"The FDA is a leader in critical path science, and the resources we've allotted them [in the budget proposal] will help continue its efforts," Bennett says. "It is important that the federal government and its private sector partners invest in this science so that we can have better medical products, lower health care costs, and ultimately personalized medicine."
Bennett even held a hearing on this topic in May at the University of Utah, bringing together government officials, academic researchers, and medical practitioners to discuss the future of critical path.
"Critical Path is very important to the FDA because now that it has greatly reduced the drug review process time, the agency wants to accelerate the process of discovery and development," Hubbard says. But he stresses that the drug safety funding is an important part of moving Critical Path efforts forward because a solid safety net will make the agency more comfortable with efforts to shave off time in drug development process.
"You're not going to be willing to jump out of a plane without a parachute," he quips. "You're more willing if you have one. And if you have a backup parachute, that makes it much more likely you'll dive out of the plane."