February 2008

AD Ally/FDA Scientific Workshop to Take Place March 13

On March 13, ACT-AD, together with the FDA, the Alzheimer’s Association and
the Alzheimer’s Study Group, will host Measures of Clinical Meaningfulness: An
AD Ally/Scientific Workshop. The workshop will serve to advance the dialogue
regarding how best to measure the clinical effectiveness of emerging therapies
while opening the door to future discussions with the FDA on the state of AD
therapies. The AD Ally/FDA Scientific Workshop will gather scientists,
regulators, drug developers and AD advocates to discuss key topics that
include:

  • Current FDA Standards for Defining Clinical Meaningfulness in
  • Alzheimer’s Disease Treatments
  • Issues and Challenges in the Context of the Current Standards for
  • Defining Clinical Meaningfulness in Alzheimer’s Disease
  • Options and Alternatives for Defining Clinical Meaningfulness in
  • Alzheimer’s Disease
  • Meaningful Changes as Viewed by the Clinician, Patient and Caregiver
  • Challenges Facing Stakeholders, Regulators and Industry

An electronic invitation for the workshop was sent to ACT-AD members on
February 13. If you plan to attend, we ask that you RSVP to
[email protected] as soon as possible to ensure that seats are
reserved.

FDA Advocacy Groups Call for Increase in FY09 Budgets

On February 4, President Bush released a proposd budget for FY 2009 which
would provide $2.4 billion in total funding for the U.S. Food and Drug
Administration starting on October 1, 2008.

If approved by Congress, the FDA’s budget would increase by 5.7%, or 2.9%
exclusive of user fees. Several concerned Members of Congress and a number
of advocacy groups are calling for additional Congressional appropriations to
strengthen areas of the Agency affected by insufficient resources.

The Alliance for a Stronger FDA seeks to increase the Agency’s appropriated
funding by approximately $380 million over the President’s proposal,
suggesting that these funds are necessary to rebuild FDA infrastructure and
fund vital programs that ensure the safety and efficacy of food, cosmetics, drugs
fund vital programs that ensure the safety and efficacy of food, cosmetics, drugs
and medical devices.

Alliance spokesperson and former FDA associate commissioner William
Hubbard has joined other former FDA officials urging a doubling of the Agency’s
budget over the next five years. Citing startling findings from the FDA Science
Advisory Board’s November report, which determined that the FDA is in critical
need of significant new resources, Hubbard noted that the Administration’s
proposed budget is only half of what the FDA needs to keep pace with inflation.

As a member of the Alliance for Stronger FDA, ACT-AD works to support the
FDA’s mission as a scientifically-based regulatory agency and advocates for
increased funding so it can better protect and help improve the health of our
country.