ACT-AD Calls for $200 Million Increase in FY 2016 Appropriated Funding for FDA

The ACT-AD Coalition has called on the U.S. Congress to increase appropriated funding for the U.S. Food and Drug Administration by $200 million over FY 2015 levels. In a letter addressed to Rep. Robert Aderholt (AL), Rep. Sam Farr (CA), Sen. Jerry Moran (KS), and Sen. Jeff Merkley (OR), the coalition requested a total funding amount of $2.8 billion. Both the U.S. House of Representatives and the Senate are currently reviewing the proposed FY 2016 federal budget.

In the letter, the coalition noted the benefits this additional funding will provide for Alzheimer’s research:

Currently, there are more than 80 compounds in various stages of clinical development for Alzheimer’s disease. Unfortunately, because of the current drug development paradigm, many of the discoveries made today cannot provide relief in time to reach the 16 million Americans expected to suffer from the devastating effects of Alzheimer’s disease by the middle of this century. FDA must sustain the level of focus and expertise needed to continue to serve as an active partner in the fight against Alzheimer’s disease.

In recent years the FDA has undertaken crucial resource-intensive initiatives like
issuing draft guidance for industry further clarifying requirements for testing early-stage
Alzheimer’s treatments and expressing the conditions under which they would consider the use of Accelerated Approval for AD treatments. Representatives from the agency also routinely participate in important national and international meetings with patient advocates, researchers, and industry focused on improving AD clinical trials.

Their participation in these discussions is essential. We cannot afford to let the FDA abandon
these ongoing activities. In fact, the agency has made finalizing its draft guidance on early
Alzheimer’s disease a priority for 2015. Having this final guidance will provide transparency and stability for those developing drugs to intervene in the earliest stages of the disease when they may have the greatest impact.

Your strong support of the FDA in FY 2016 would acknowledge the important role it plays in ensuring that we are better prepared to meet the challenges posed by Alzheimer’s disease.

To read the entire letter, please go here.