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The FDA wants you!

April 23, 2013|By Melissa Healy
  • The Food and Drug Administration, headed by Commissioner Margaret Hamburg, is opening its processes for more consumer scrutiny. A new website offers a portal for that.
The Food and Drug Administration, headed by Commissioner Margaret Hamburg,… (Michael Reynolds / EPA )

The Food and Drug Administration, acting on a law signed by President Obama in 2012, has launched the third phase of an initiative to increase patient participation in the regulation of drugs and medical devices. On Wednesday, the agency went live with a new website aimed at demystifying the regulatory process for consumers and patient advocates.

The new FDA website, called FDA Patient Network, is designed to educate consumers on the process of getting medical devices and drugs from the idea stage to pharmacy and hospital shelves. Along with the FDA Commissioner's blog, this is the agency's bid to be more transparent.

The new website is also a recruiting device of sorts: The FDA says it is looking for patient representatives to "share ideas" about the drugs and medical devices. The FDA Patient Network will be a gateway for caregivers, patients and patient advocates to email their views and hear live chats, webinars and open meetings, including those of the scientific advisory panels that meet to recommend for or against new drugs' approval by the agency. Consumers can also sign up to testify before or participate in some of the FDA's meetings.

FDA officials are now organizing the second annual meeting of the newly formed Patient Network, to take place this summer. That meeting will focus on helping advocates and consumers understand the often fiendishly complex decision-making process. "Medical product development isn't just a simple 1-2-3 recipe," said Richard Klein, director of the FDA's Patient Liaison Program.

This is also a one-stop shop for checking out clinical trials that may be of interest, for learning about drugs or devices that FDA has approved or recalled, and to understand the limits of FDA's powers -- say, to restrict "off-label" use of medications it approves, or to proactively regulate dietary supplements.

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