July 2010

Congress Acts to Increase Funding for FDA

Before Congress adjourns for its August recess, House and Senate appropriators took some important steps toward increasing funding for the U.S. Food and Drug Administration (FDA). On June 30, the House Appropriations Subcommittee on Agriculture, Rural Development, and the FDA approved its Fiscal Year 2011 appropriations bill.  The bill included $2.571 billion for FDA, a $214 million increase over Fiscal Year 2010.  On July 15, the Senate Subcommittee moved to approve its version of the bill which included a lower 6% ($158 million) increase in funds for the agency.

Both bills include language instructing that funds for the FDA should be used to advance regulatory science to help build scientific infrastructure, develop standards for new and emerging technologies, modernize standards for evaluating products, and accelerate the development of essential medical therapies. The Senate bill falls just short of the $25 million included in President’s Budget and the House bill for this purpose. Further action on the proposals is not expected until Congress returns in September.

There is some concern that because Congress has been slow to move the appropriations process forward up until this point that the traditional process of passing stand-alone bills will need to be circumvented and result in a consolidated continuing resolution (CR) extending funding through 2011 at reduced levels.  This would occur prior to the start of the new fiscal year on October 1. Coalition members should be mindful of this possibility and reinforce with members of Congress the ongoing need for strengthening the FDA.  However, we should also be encouraged that members of both panels continue to place a high priority on supporting the agency, even in tough economic times.

ACT-AD and the International Conference on Alzheimer’s Disease

The 13th Annual International Conference on Alzheimer’s Disease (ICAD) took place in Honolulu,Hawaii from July 9 to July 15, 2010.  At this conference, Alzheimer’s experts from around the world gathered to discuss significant breakthroughs in the field of Alzheimer’s research and present results from clinical trials of potential AD therapies.  The ACT-AD Coalition had a presence in Honolulu during the conference.

On July 11, ACT-AD sponsored an informal meeting of leading Alzheimer’s experts from the U.S. and Europe.  The meeting provided an opportunity for these experts to share their insights into how the development and evaluation of novel AD therapies could be improved.  ACT-AD and its members were recognized during this meeting for the work they do to help move the Alzheimer’s field forward on scientific issues that affect the way new therapies are developed and reviewed, as well as to provide forums where thought leaders can present possible solutions to regulators.