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FDA Wants YOU (to Get Involved)

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Watch this video to learn more about FDA's Patient Network initiative, then visit the Patient Network website.

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You may know that the Food and Drug Administration (FDA) is responsible for protecting your health by ensuring that the food you eat is safe, and that the drugs and medical products you and your family use are safe and effective.

But did you also know that FDA needs your help?

"It's true," says Richard Klein, director of FDA's Patient Liaison Program within the Office of Health and Constituent Affairs. "We invite consumers to get involved in the process of helping FDA make the decisions that affect their lives."

And thanks to FDA's Patient Network initiative, it's easy.

According to Klein, FDA has a long history of working with patients and patient advocates representing specific groups, beginning with the AIDS crisis of the 1980s. Since then, FDA has reached out to advocacy groups, such as the National Council of Rare Health Disorders and other disease-specific groups, to ask for their input on proposed regulations and guidance documents.

More recently, in July 2012, President Obama signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA) which calls for the agency to increase patient participation in the regulation of medical products.

According to project manager James Valentine, M.H.S., the Patient Network helps to bring the unique perspective of patients, family members, caregivers and patient advocates to the decision-making processes of the FDA. There are a number of ways to become involved, including becoming a patient representative on a committee that advises FDA on key issues.

Valentine explains that the three-phase program began in 2011 with the launch of the twice-monthly newsletter Patient Network News. A recent issue includes information on a product that has been linked to potentially serious eye infections; an upcoming public meeting on breast cancer; a story on active ingredients in children's medicines; and information on pet health. "It's a good way to find out just what FDA is up to—and in ways that are relevant to you, the individual," Valentine says.


The annual Patient Network meeting, the second of which will take place this summer, is the second phase. "We're gearing up for it now," Klein notes.

By popular demand from patient organizations, Klein says, the meeting will focus on "demystifying the FDA, by providing a basic primer about medical product regulation." "We need to demonstrate that from both FDA's and industry perspectives medical product development isn't a simple 1-2-3 recipe," he adds.

Phase 3 is the FDA Patient Network website, to launch the week of April 22, 2013. The website is an interactive tool for educating patients, patient advocates and consumers on how their medications and medical devices go from idea to the shelf.

FDA launched the site to engage patients and consumers as partners, and encourage them to share ideas and concerns about the medical product development process.

"When it comes to FDA's regulatory process, we feel very strongly patients should have a say," notes Klein. "The new website provides an excellent place to start."

According to Klein, consumers have complained that they find it difficult to locate the information they need on the agency's website, and when they do, it is targeted for industry use.

"This website provides a concentrated, one-stop forum from which we can reach patients and vice versa," Valentine says. The website connects patients, caregivers, and advocacy groups to the agency through e-mail, webinars, live chats, open meetings and announcements of opportunities for patients to comment on FDA regulations.

There are sections on what FDA does, FDA advisory committees, FDA initiatives, and frequently asked questions. The website also helps patients, caregivers, and advocacy groups find information on:

  • getting involved in the regulatory process;
  • finding relevant clinical trials;
  • finding additional treatment options;
  • getting information about diseases; and
  • getting information about their medications, including whether they have been issued a warning label or recalled from the market, whether there are other, off-label uses of the drug, or if anyone has had an adverse reaction to their medication.

"We've worked hard to make it easily navigable and user friendly," Valentine says.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

April 23, 2013


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