As a follow up to our recent note on the FDA’s launch of the Patient Network Web site, Connexion Healthcare attended the inaugural “Live Chat” Town Hall Meeting on May 21, 2013. This 50-minute, real-time, interactive Web event centered on ways the FDA Patient Network Web site can help the FDA Office of Health and Constituent Affairs (OHCA) engage patients in discussions about their disease and elicit patients’ perspectives on their disease in regard to regulatory decision-making. Dr Richard Kline, Director of the Patient Liaison Program of Office of Health and Constituent Affairs (OHCA), who hosted the broadcast, addressed these issues and provided an overview of the new Web site, which was launched on April 23, 2013.
The Web site was developed using patient input, and, as Dr Klein emphasized, patient feedback will be used to “grow the Web site for patients.” One function of the Web site is to serve as a portal to recruit a broader base of much-needed “patient representatives,” who serve as lay consultants to the FDA on regulatory processes. Today, nearly 200 patient reps represent about 100 diseases, but a need exists for patient reps who have a rare disease.
During this Live Chat, participants e-mailed questions about eligibility requirements for being a patient rep. Dr. Klein responded that “the expertise of the patient is their experience [with the disease].” Patient reps are people who have their “finger on the pulse of the larger disease community, who know what drugs are being developed, and who can connect their personal experience with the data.”
The FDA Patient Network Web site itself offers a tremendous opportunity for patients to learn about and voice their opinions on their own disease. It is brimming with ways to take action, get informed, and talk to the FDA—and it’s easy to navigate. Dr. Klein emphasized the large amount of viable, practical patient information on the site, information on drug and device approval, access to MedWatch to report unexpected adverse events related to therapeutic medicinal products, and ways that patients who have exhausted all approved therapies can find other treatments. Patients can make their voices heard about their rare disease or chronic condition as it relates to FDA decision-making, can submit questions to the FDA, and can find out how to attend advisory committee meetings. A calendar of public hearings, which patients can attend, is posted on the Web site. Archival Webinars by FDA experts are also posted, including Webinars on topics for patient reps. Free subscription to an e-mail newsletter is also offered that provides an overview of “Federal Register” (the daily journal of the federal government) Notices, along with safety updates, and updates on drug recalls, drug shortages, and new drug approvals.
According to Dr. Klein, over the next 5 years OHCA will be addressing the inadequately met medical needs of patients. The focus will be on 20 different diseases through interactive meetings and advocacy groups, “but primarily through the voice of patients.” These meetings will focus on the main issues that remain to be addressed for each disease, along with patients’ input about their daily functioning and symptoms and how patients weigh the risks versus the side effects of treatments. Dr. Klein related that the first meeting on chronic fatigue syndrome was a “huge success.” The topic for the next scheduled meeting is HIV treatment and cure.
Live Chats are scheduled to occur quarterly, and audios will be posted on the Web site. The next planned Live Chat Town Hall Meeting will address the issues and complexities of developing products for rare diseases. A member of the Office of Orphan Products Development will be the host.
Office of Health and Constituent Affairs
FDA Patient Network Web site