FDA Embarks on Unprecedented Initiative for Transparency in Patient Communications


The Food and Drug Administration (FDA) has launched its long awaited website called FDA Patient Network. The FDA Patient Network is part of the Office of Health and Constituent Affairs (OHCA) and seeks to help patients, patient advocates, and their health professionals connect with FDA during the drug approval and commercialization process.  This marks the entrance of a critical new voice in the conversation on patient care and transparency. Conversations between patients and doctors and patients and drug developers that were once held behind closed doors will now be held in an open public dialogue.

Patients can interact with the FDA officials through open meetings, email, and webinars and have opportunities to comment on FDA regulations. The FDA is also using the website to recruit patient advocates that could in turn help the FDA make more informed decisions on certain treatments. Most importantly, the Patient Network represents a place for clarity for those patients who are confused on how FDA operates, what the organization actually does, and how the drug approval process works.

Margaret A. Hamburg, M.D., Commissioner of the FDA, writes in her blog regarding the website launch, “When patients better understand the intricacies of how medical products are studied, reviewed, assessed and brought to market, their input will be that much more focused and valuable.” This statement addresses the growing sentiment of many today. Patients want more transparency – in healthcare costs, in their drugs and treatments, the quality of the service they are receiving – and as producers of the good and services they buy, the healthcare community owes them that much.

The FDA, the regulating body of U.S. healthcare, has made a small but very significant step in creating an environment where patients can freely ask the questions they want on the status of new drugs treatments – Why is it taking so long to get to market? Why has one drug been approved over another? Has the FDA taken into consideration the implications of adding a new narcotic into the market and how the availability of these medicines affects American families?

A key question is how will pharma, biotech, medical device and health services companies drive the conversation when they are no longer the only players in a room but instead joining a roundtable discussion? As healthcare communication professionals, we advise our clients to engage with patients in multiple educational formats, such as unbranded websites to provide unbiased educational information on the therapeutic area of interest to them; it demonstrates their long-term commitment to patient communities. In the future, we may advise to go a few steps further and create a venue where patients are allowed to ask the “whys” – why this drug, why this indication, why is it taking so long? We need to work with our clients to become more comfortable in participating in conversations online, even when we know the questions won’t be easy to address, and help them build a community, just like the FDA Patient Network, where patients feel at ease asking the tough questions and where they trust they will get an honest answer.

Photo courtesy of  Brandon Giesbrecht on Flickr

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: Victoria Aguiar