Bringing Real Life to the Table: Patient Reps Help FDA Review Products
Meadows, Michelle, FDA Consumer
When Jim Anderson of La Plata, Md., became an FDA patient representative in 1997, he wasn't sure how much help he could be. In preparation for his first advisory committee meeting, the Food and Drug Administration sent him a new drug application (NDA) briefing package, which he describes as "10 pounds of paper."
"I couldn't pronounce half the words," he says, "and I was scared to speak ..."
But the fear didn't last long, says Anderson, who was diagnosed with prostate cancer in 1993. He recalls reviewing a drug that gave "a small chance to provide pain relief and a significant risk of heart failure," in his opinion. He was glad he spoke up about it because his concern prompted a serious discussion among the scientists and doctors.
Anderson was one of about 23 patient representatives who gathered in Rockville, Md. for an FDA training workshop in September. Since 1991, patient representatives have served on FDA advisory committees to help review products. Advisory committees provide a forum through which the FDA seeks advice from outside experts and consumers.
Patient representatives give the FDA and its advisory committees insight on issues and questions important for patients and family members living with serious and life-threatening illnesses. The patient representative program began after Congress passed legislation requiring consumer representation on advisory committees and HIV/AIDS advocates demanded to be included on advisory committees that review products affecting their lives. Over the years, the FDA saw the significant contribution HIV/AIDS patients made to the regulatory review process, and the distinct category of patient representatives was expanded to include other committees.
FDA experts in the areas of drugs, radiological health, medical devices, and biologics briefed those at the workshop on the agency's product review process. Among the workshop agenda topics was how to sift through the hefty NDA applications, which contain results from animal studies, clinical tests, and other drug information. Patient representatives should expect to spend at least 10 hours reviewing the material before an advisory committee meeting.
Patient representatives typically have experience with and are knowledgeable about a specific serious or life-threatening illness. They also typically have a formal affiliation with a patient advocacy organization. About 60 patient representatives now serve on the FDA's 32 advisory committees.
Most patient representatives serve on committees that review products related to HIV/AIDS and cancer. But additional diseases, such as arthritis, diabetes, lupus, and Parkinson's disease, are also included. Patient representatives are reimbursed for travel, lodging, and daily expenses. A modest honorarium is provided for each day of service at the meeting.
During the fall workshop, Steven Hirschfeld, M.D., Ph.D., a medical officer in the FDA's division of oncology drug products, described the challenge of pinpointing the indicators that reasonably predict whether a drug will have a benefit. …