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FDA Patient Consultant Program to Include Parkinson's
On February 8, Dr. Lester Crawford, the Acting Commissioner of the U.S. Food and Drug Administration (FDA), announced that the agency's Patient Consultant Program will be expanded to include Parkinson's 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. Advocates from the HIV/AIDS patient community were the next group to be added, and Parkinson's advocates will be the third.
FDA will recruit, select and train Parkinson's 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 a 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 the 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 FDA's Rockville, MD facilities, at the agency's expense.
Perry Cohen, Ph.D., founder of the Parkinson Pipeline Project - a grassroots patient-centered group that is dedicated to involving patients in the treatment development process, and that is affiliated with PDF - described the move as a "decisive and thrilling step towards recognizing the necessary role of patients in drug and treatment development." Dr. Cohen, who has lived with PD for almost a decade, was instrumental in conceiving and bringing the Parkinson's component of the program to fruition.
Information regarding how to apply, FDA's 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 FDA employees JoAnn Minor or David Banks at (301) 827-4460.