FDA Seeks To Include Those Most Affected By Alzheimer's Disease In The Drug Review Process

The U.S. Food and Drug Administration (FDA) has expanded its Patient Consultant and Patient Representative programs to include individuals in the early stages of Alzheimer's disease and their caregivers. The FDA made the change in response to a request by the Alzheimer's Association encouraging the agency to give people directly affected by Alzheimer's a more active role in the review and approval of new Alzheimer drugs.

"People who are living with this terrible disease have much to offer to the pharmaceutical industry, researchers and government regulators, and their voices must be heard," said Harry Johns, president and CEO of the Alzheimer's Association. "We are pleased that the FDA understands the value of involving Alzheimer families in regulatory decisions that affect them and appreciate that the agency was so responsive in expanding their patient consultant program."