FDA Promotes Transparency and Patient Engagement with New Website

by Nancy Fabozzi 30 May 2013
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The FDA Patient Network

On April 23, FDA Commissioner Margaret Hamburg, M.D. announced the launch of The FDA Patient Network website in a blog post on the FDA site. Hamburg states that the “FDA Patient Network website is an interactive tool for educating patients, patient advocates, and consumers on how their medications—both prescription and over-the-counter—and medical devices move from the realm of idea to the realm of the marketplace.” The objective, according to Hamburg, is for patients to have a bigger voice so they can “get informed and get involved” to help the FDA improve patients lives. The feature rich website is designed to provide a “one stop shop” for patients seeking information about a variety of drug and medical device issues including the safety and effectiveness of new therapies; locating clinical trials; potential warnings and adverse effects; information about the FDA’s process for approving medical products; methods of engaging with FDA representatives; and a variety of other issues. According to a recent article in Healthcare IT News, author David Harlow states that the FDA Patient Network was developed “after nearly four years of research, focus groups, usability testing” and that the “win goals for the website are “promoting the educational mission of the FDA, and promoting opportunities for patient advocacy within the FDA.” In launching the new website, the FDA hopes to “expand the role of patients beyond the select group of patient representatives and to engage a wider audience of patients in new and broader ways.”

FDA's Office of Health and Constitutent Affairs

The new FDA patient portal is a user-friendly way for people to interact with FDA officials through meetings, webinars, chats, email, and other venues so that they can have a more active role in the research and development of essential medical products. The website is an extension of the FDA Patient Network, a program begun in 2011 as part of the FDA’s Office of Health and Constituent Affairs (OHCA). The OHCA was formed in 1987 in response to growing levels of patient activism emanating from the HIV/AIDS community. Since its founding, OHCA has continuously evolved in its efforts to help patients navigate the complexities of the FDA and promote the patient perspective in all FDA activities, especially through its Patient Representative program. FDA Patient Representatives are usually people who have a history of a particular disease and are thus selected as a voice for patients’ concerns. In 1991, the first Patient Representative served on the FDA’s Antiviral Drugs Advisory Committee for HIV, and by the mid 1990’s, Patient Representatives had voting privileges on FDA Advisory Committees for cancer therapeutics. By 2001, the role of Patient Representatives was further expanded to include serving as consultants to medical product review divisions as well as taking part in decision-making at meetings between the FDA and medical product developers. Today, the FDA currently has more than 160 Patient Representatives participating in the program.

Patient Engagment Movement Will Impact All Sectors of the Healthcare Market

The patient engagement movement is shaping up to be a significant cultural shift impacting stakeholders at every level of the healthcare system. The many drivers of this trend include greater consumer access to medical information via the Internet as well as the need for patients to take on increased financial responsibility for their healthcare costs, particularly with the rise of high-deductible health plans. Undoubtedly, a certain lack of trust stemming from the complexity of the U.S. healthcare system plays a role in patients’ demanding more open channels of communication including more information about the arcane mechanisms of the development (and pricing) for products and services. In addition, consumers are increasingly demanding more information about the safety and effectiveness of various healthcare products and services. Manufacturers and providers must recognize that the era of the passive patient is over. Developing new and innovative strategies for engaging patients is a critical survival strategy in today’s highly competitive marketplace. The FDA has been very proactive over the years in their efforts to involve patients and their advocates in the decision-making process. The FDA has been ahead of the curve in anticipating the growing demand of patients seeking more transparency and greater input into their healthcare decisions. Open communication and ease of access to information are the core ingredients to successful patient engagement. The FDA Patient Network website is a valuable resource that will help medical consumers easily access authoritative resources about critical issues concerning their medical treatment. We commend the FDA for this new effort and hope that it will serve as an example to similar patient engagement efforts among government agencies, advocacy organizations, providers, manufacturers, and health IT vendors.



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