Meeting Face-to-face Makes All the Difference

By: Heidi C. Marchand, Pharm.D.

While to many, the cherry blossoms in Washington, D.C., signal spring, for my office the season means bountiful opportunities to meet with groups in town for meetings and conventions in our capital city.

Heidi MarchandPatient and health professional advocacy groups that are some of FDA’s key stakeholders come to FDA Headquarters in nearby Maryland —or we go downtown to their meeting sites—for a mutual exchange of information that often has a profound influence on how we do our jobs protecting and promoting the public health.

So far, we have had informative discussions with groups as varied as the American Association of Nurse Anesthetists, the American Academy of Pediatrics, the American Celiac Disease Alliance, the ALS (Amyotrophic lateral sclerosis) Association, and Parent Project Muscular Dystrophy.

Because we are part of the Office of the Commissioner, we’re familiar with the agency across its various centers and are ideally positioned to connect stakeholders with the experts best suited to answer questions and offer assistance.

We hear from individuals on the front lines—parents of patients with heartbreaking childhood diseases, nurses who witness firsthand the consequences of a medical device that fails to work properly, patients who want to know where and how they can participate in clinical trials.

Many are experts in their area of advocacy—they’ve had to be—and their insights are invaluable.

Putting What We Learn To Good Use

For example, as we developed a rule, mandated by Congress, to define the term “gluten-free” for voluntary use in food labeling, we not only opened the proposed regulation up for public comment on two separate occasions, but we also conducted listening sessions with groups representing people with celiac disease, who must avoid consuming gluten but want a diverse and nutritious diet. They talked about the difficulties they face in trying to identify foods that won’t endanger their health, shared information about their understanding of challenges facing the food industry, and discussed the science that underlies this issue. This information helped us to ensure that the final rule was responsive to their needs. Now people with celiac disease can be assured that if they see “gluten-free” on food labels, that term has a specific, nationally uniform (and federally enforceable) definition.

Of course, our outreach efforts extend beyond these meetings. Our staff keeps in close touch with patient and health professional advocacy groups throughout the year, and through our FDA Patient Network website where we provide information on public meetings, current FDA draft guidances, clinical trials, and drug and device approvals. In addition, our patient newsletter keeps our stakeholders apprised of this and other important work FDA is doing.

But there’s nothing like meeting face-to-face across a table.

We listen to what our constituents have to say, we take it to heart, and we share it with our colleagues. What we learn through these conversations informs our work. It becomes part and parcel of the regulations we put into place to promote and protect the public health.

Heidi C. Marchand, Pharm,D., is Assistant Commissioner in FDA’s Office of Health and Constituent Affairs

Help FDA Help Patients Have a Bigger Voice

By: Margaret A. Hamburg, M.D.

Get Informed. Get Involved. Help FDA Help Patients Have a Bigger Voice.  That’s the slogan of a new FDA web site that I’m excited to announce today. The FDA Patient Network has been designed from the ground up to focus entirely on patients.

Margaret Hamburg, M.D.FDA has long been developing ways to increase patients’ interest and participation in the agency’s work, and in the policies and decisions that affect them.

Since the early 1990s, FDA has been working directly with patients and patient advocates to help them learn more about how medical products are developed and regulated. Patient representatives participate in FDA advisory meetings, and contribute the important perspective of their patient community. 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. We hope, with the launch of this new web site, 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.

The FDA Patient Network web site 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. It brings together, in one place, information that is important to patients, making it easier for them to find what they are looking for and to understand the significance of their findings.

This web site will open new channels of communication with the public, such as live chats with senior agency officials. It will help patients and consumers better understand the process for determining whether medical products are safe and effective and encourage them to contribute their ideas and concerns about the development and regulation of these products.

I am excited because this new Patient Network web site provides a new model for FDA to follow in making its inner workings transparent to the public. It ushers in a new era of access and input for patients and consumers that will evolve with the needs of both communities. I encourage you to explore the new site at

Margaret A. Hamburg, M.D., is Commissioner of the Food and Drug Administration

Watch this video to learn more about FDA’s Patient Network initiative: