One such letter to General Mills admonished the cereal company that health claims printed on Cheerios boxes essentially make the cereal a drug to FDA. The notice went on to note that it “may not be legally marketed with the above claims in the United States without an approved new drug application.” The FDA did not dispute the science or validity of the claims; but decreed that General Mills could not put the health information in advertisements without agency approval to market the cereal as a drug.

 

In late March, 2009 strong warning letters were sent to 14 pharmaceutical companies about online search advertisements. Search ads are sponsored links above or in the right margin of search results on a Google (or other search engine) page, similar in appearance to search result entries. Search ads are limited to 95 characters, and the link redirects to a brand web site or sales page where product information, including risk warnings, is displayed.

 

The letters from the FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) sternly warned that the search ads for prescribed drugs did not include the paragraphs of precautions required by the agency. Prior to receipt of the letters, pharma and advertising companies had followed an informal “one click” rule, believing that if risk information was furnished on the page the search ad linked to -- one click away -- the material was in compliance. Not so, according to the new FDA determination.

 

Companies have changed their search ads to comply with the letters, but industry spokesmen say the solution is a problem, and that the FDA’s guidance is now confusing and misleading. Their concern is that regulators are enforcing standards created for print and broadcast, rather than devising rules that are compatible with the way Internet advertising works.

 

 

Bowing to requests by consumers, drug firms, marketing agencies and others, the Food and Drug Administration held a public hearing on human and animal drug promtion using Web 2.0 and social media tools.  The hearing took place on November 12-13, 2009.  According to the FDA, the hearing was designed to: "help guide FDA in making policy decisions on the promotion of human and animal prescription drugs and biologics and medical devices using the Internet and social media tools. FDA [received] input on a number of specific questions but [was] interested in any other pertinent information participants in the hearing shared."
 

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