January 2008

Letter from the Chairman: Alzheimer’s Scientific
Workshop and the FDA

Dear ACT-AD Member,

In 2007, one of our top priorities was to work with the FDA on opening a broader discussion about Alzheimer’s, working cooperatively with the agency to highlight the critical need for new treatments. We are pleased to announce that FDA leadership is joining ACT-AD on a series of AD Ally meetings designed to build a productive dialogue to help inform the review of transformational therapies for AD.

The first of these ally meetings is being planned for March 13 in Rockville, MD, and we want you to be sure to hold that date on your calendars.  ACT-AD, together with the FDA, the Alzheimer’s Association and the Alzheimer’s Study Group, are in the midst of planning the scientific workshop looking at better ways to identify and measure benefits from therapies that are meaningful to Alzheimer’s patients, caregivers and physicians.

We will be sending a formal invitation in February that includes additional details about the workshop. In the meantime, if you have questions or would like additional information, please call me at 202.293.2856 or via email at [email protected]

Best regards,

Dan Perry

FDA Science Board Calls for Increased Funding at the FDA

In December the FDA Science Board Subcommittee met to discuss the, “FDA Science and Mission at Risk,” a recent report on the state of science at the FDA. The result of a year-long review, the Subcommittee’s 300-page report concluded that the states of the FDA’s scientific and regulatory programs are at risk due to insufficient resources.

The FDA’s chief commissioned the report to assess whether its scientific expertise can support its regulatory mission. The report found that the FDA’s regulatory priorities are reactive, especially in the food safety units.  The report also cited poor retention of critical staff, noting the turnover rate of the science staff is twice that of other government agencies.

After reviewing the report, the Alliance for a Stronger FDA felt that there were key problem areas within the agency that could be bolstered with appropriate resources. As a member of the Alliance, 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 the health of our country.