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FDA Expands Patient Consultation Program to Include Parkinsonís Disease

On February 8, Dr. Lester Crawford, the Acting Commissioner of the U.S. Food and Drug Administration, announced that the agencyís Patient Consultant Program will be expanded to include Parkinsonís disease. The FDA Patient Consultant Program was designed to incorporate the perspective of patient advocates into drug development, and began (in 2001) with the cancer community. The HIV/AIDS patient advocates were the next group to be added and, and Parkinsonís advocates will be the third.

FDA will recruit, select and train Parkinsonís disease patient advocates for the program. Those selected will serve as patient consultants primarily on the research phase of such development that precedes approval and general release of the treatment. The patient consultants will provide advice to FDA and to the drug sponsor on such topics as clinical trial design, endpoint determination, expanded-access protocol development and clinical trial patient recruitment strategies. FDA will arrange for patient consultants to participate via telephone in FDA in-house meetings and meetings with sponsors.

The advocate selection process will be managed by the Office of Special Health Issues (OSHI) in collaboration with the Division of Neuropharmacological Drug Products (DNDP) and the Center for Drug Evaluation and Research. Once selected, the consultants will be hired as Special Government Employees and will be subject to FDAís same conflict of interest and confidentiality regulations that govern all other employees, consultants and advisors to the FDA. Each new consultant will receive training at FDAís Rockville, MD facilities, at the agencyís expense.

Dr. Perry Cohen, founder of the Parkinson Pipeline Project, a patient-centered group that is affiliated with PDF, described the move as a ďdecisive and thrilling step towards recognizing the necessary role of patients in drug and treatment development.Ē Dr. Cohen, who has lived with Parkinsonís for almost a decade, was instrumental in conceiving and bringing the development to fruition.

Information regarding how to apply, FDAís selection criteria and processes, training and consulting is available from the FDA Office of Special Health Issues at www.fda.gov/oashi/cancer/pconback.html. For further information, please contact JoAnn Minor or David Banks at (301) 827-4460.

Source Date: Mar 02 2005