ADMINISTRATION'S COMMITMENT TO CRITICAL PATH IN BUDGET FALLS SHORT, SOURCES SAY
The Bush administration is not providing sufficient funding or making the argument for the FDA's effort to improve drug development, known as the Critical Path Initiative, observers say.
While the administration in its fiscal 2008 budget request urged Congress to provide $15 million to develop personalized medicines, there was no such support for the Critical Path Initiative, sources said. In the HHS' budget document, the agency says that the $15 million is necessary for "improving the quality and effectiveness of healthcare, providing the right care to the right patient at the right time, and getting it right the first time." Personalized medicines are developed to treat certain subsets of the population based on their particular genetic makeup.
However, proponents of the Critical Path Initiative program say that it would pave the way for personalized medicines. The initiative will allow the agency to validate discoveries and better replicate testing to further development of personalized medicine, Ray Woolsey, president and CEO of the Critical Path Institute (CPI), said. CPI's mission is to support the FDA in implementing the Critical Path Initiative.
"The increasing complexity of 21st century science means FDA must have evaluatory tools and methodologies that do not yet exist or which have never been validated," Steven Grossman, executive director of the FDA Alliance, added. "This requires an agency wide investment in good science -- be it in food, drugs, biologics or nanotechnology. The Critical Path Initiative, vital to the future of biomedicine, is one of these 'good science' initiatives that will need to grow as part of strengthening the agency." The FDA Alliance is a coalition seeking increased agency funding.
The funds the administration proposed for Critical Path are insufficient, these sources added. The fiscal 2008 budget's proposal of nearly $6.7 million, equal to the administration's fiscal 2007 request, is "far less than is needed," Woolsey said. "If you look at the 76 projects on the opportunity list and you think about how much it would cost for the FDA to actively participate in a significant number of these, it will surely need an order of magnitude more" such as $50 million.