FDA Teams With WebMD For Wider Dissemination Of Product Safety Info
Full article reprinted from "The Gray Sheet" - December 8, 2008
Find out how FDA will reach a vastly larger audience for product safety alerts through a new partnership with the popular health information Web site WebMD, announced Dec. 3.
The agreement calls for WebMD to feature at least 50 FDA-written articles on its Web site during the coming year, plus provide a link to FDA's full catalog of consumer updates.
WebMD will also publish FDA consumer health information in at least three issues of WebMD the Magazine. The bimonthly print publication is distributed to 85% of U.S. doctors' offices.
FDA currently uses a 1Consumer Health Information page on its Web site to publicize information about safety concerns with specific devices, drugs and foods. The site currently includes, for example, a warning that unapproved decorative contact lenses can injure the eyes, and a notice that Advanced Bionics' HiRes90k implantable hearing aid contains a defective component and poses a health risk.
While the agency's consumer information page receives about 130,000 views per month, WebMD.com has nearly 50 million unique users each month, the firm says. The WebMD magazine, meanwhile, reaches roughly 9 million.
In a Dec. 3 press conference, FDA Commissioner Andrew von Eschenbach heralded the partnership as enabling greatly expanded dissemination of "material we believe is extremely important for consumers to be aware of as they are making critically important decisions for themselves and for their families about their health."
The agency's articles will appear in an exclusive FDA section of the WebMD.com site and will be clearly identified as coming from FDA, WebMD CEO Wayne Gattinella said. Pages containing FDA material will be free of advertisements to avoid any suggestion of product endorsements.
While FDA's postings are expected to address recalls and safety issues, they will not be limited to product problems. For example, articles also may alert consumers to the availability of new, innovative solutions to disease processes, von Eschenbach said.
Harvard cardiologist and director of the Medical Device Safety Institute William Maisel praised the effort. "It's nice to see the FDA getting the message that they need to do a better job of communicating with consumers," he said in an interview.
But, Maisel added, "reaching consumers is only the first step in educating consumers." To be effective, FDA's articles should go beyond merely stating that there is a potential problem with a product and advising patients to consult their doctor, he said.
Rather, FDA should explain the precise hazards and adverse events it has seen and the types of patients most at risk, so that the reader understands not just general user population risks, but whether he or she as an individual is at risk.
"Patients don't want to be treated like infants, where the information goes to their physician and if they're lucky their physician might call or give them some version of the information. They're smart and educated and proactive, and they want to hear the information" directly, Maisel said.
"Well-written statements that contain factual information can accomplish that goal."
First Of Many Expected Collaborations
The partnership grew out of FDA's ongoing exploration of ways to enhance communications with the public, von Eschenbach said, adding that there are likely to be similar collaborations with other outlets in the future (2"The Gray Sheet" Aug. 18, 2008, p. 10).
"I've been carrying on conversations with a whole host of organizations and entities that are engaged in information technologies and communications, and this just happens to have ... matured to the point where we actually have an initiative," he said. "Hopefully others will take note of this and come forward with their enthusiastic interest in creating a similar kind of relationship with the FDA."
Details of the partnership are laid out in a 3memorandum of understanding signed by WebMD and FDA Oct. 10.
- Mary Houghton
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Full article reprinted from "The Gray Sheet" - December 8, 2008
