April 2008

ACT-AD Urges Congress to Increase Funds for FDA

At a Senate Agriculture, Rural Development, FDA and Related Agencies Appropriations Subcommittee hearing on April 15, FDA Commissioner Andrew von Eschenbach testified on the Agency’s proposed budget for fiscal year 2009.  During this hearing, senators from both parties, including Subcommittee Chairman Herb Kohl (D-WI), publicly recognized that the FDA is seriously under funded.

In a March 31 letter to the chairs of both the House and Senate Appropriations Subcommittees with jurisdiction over FDA funding, ACT-AD called for an increase in funding for FDA drug review and safety activities in fiscal year 2009. The Coalition supports an $80 million increase for the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research’s (CBER) (over and above the fiscal year 2008 level).  The Coalition’s hope is that the additional resources will strengthen CDER and CBER’s ability to review new Alzheimer’s disease therapies.

ACT-AD member organizations that endorsed the letter include: Alliance for Aging Research, Alzheimer’s Drug Discovery Foundation, Alzheimer’s Foundation of America, American Association for Geriatric Psychiatry, American Federation for Aging Research, American Health Assistance Foundation, FasterCures, International Longevity Center-USA, National Council on Patient Information and Education, RetireSafe, Society for Women’s Health Research, and Strategic Health Policy International.

Read the full ACT-AD letter here.

Alzheimer Research Forum Highlights AD Allies/FDA Scientific Workshop

The Alzheimer Research Forum, a prominent online resource for understanding all aspects of Alzheimer’s disease, released an article summarizing highlights of the ACT-AD sponsored AD Allies/FDA Scientific Workshop held on March 13, 2008 inRockville,MD.

The article, titled “Alzheimer Activism: How to Modernize Clinical Trials?”, details the events of the March 13th workshop in light of the central theme, what constitutes a clinically meaningful outcome for a new generation of Alzheimer’s therapies and how they will garner FDA’s support.  The article credits the Coalition for this key dialogue on clinical meaningfulness between the FDA, the scientific community, AD advocates, and industry.

Read the article here.

IOM Focuses on Science at FDA and Patient Access to Treatments

On April 21, the Institute of Medicine hosted a policy forum to examine the FDA’s current capacity and explore opportunities and challenges posed by the rapidly shifting scientific landscape. Experts from academia, industry, and government discussed emerging fields such as genomics, nanotechnology, regenerative medicine, and information technology. It was apparent from this discussion that their applications in the treatment of disease are endless. However, these experts expressed concern over whether or not FDA is fully equipped to adapt to them.

During the forum, representatives from cancer and juvenile diabetes organizations also participated in discussions focused on FDA’s mission and responsibilities. Each spoke about their organization’s interaction with the FDA and the important role the Agency plays in patient access to therapies.  Their experiences mirror those of the Alzheimer’s advocacy community. Both echoed the Coalition’s desire for FDA to embrace innovations that will speed the delivery of more effective treatments to patients.

View related slides, Sigal and Goldstein.