‘One-Click' Rule Is Not Good Regulatory Policy
by Mark Tosh, Editor-in-Chief, DTC Perspectives

Diana Zuckerman, Ph.D., president of the National Research Center for Women & Families, told the FDA that the regulatory bar should be set higher for all DTC promotion by pharma companies, not just the promotion using new media channels. She also asked FDA to be more aggressive in monitoring online promotion and noted that her non-profit group would push for increased industry user-fees next year to give FDA added resources for the monitoring efforts.

• “DTC regulations need to be improved and enforced, and those regulations should be the minimum requirement for ads on the Internet and other media,” Zuckerman said.

Speaking on the opening day of the hearings, Zuckerman acknowledged that companies face higher costs to include additional fair balance in TV, radio and print ads. “That isn't true for the Internet, smart phones or other digital hardware,” she added. “FDA should demand much better information about risks in all media, but especially the Internet and other new media. Risk information and other caveats about safety or effectiveness should be as prominent and persuasive as the information about benefits. It should be as accessible – not hidden behind or below the more positive promotional information—and should not require clicking other links. One click away is one click too many. If the information about benefits doesn't require a click, the information about risks shouldn't require a click either.”

To ensure the balance and accuracy of advertising online or via other new media “will require substantially more resources for the FDA. Realistically, that money will need to come from new industry user fees. We will join Consumers Union and other consumer groups to advocate for that as part of the PDUFA 5 negotiations next year,” she explained.

Zuckerman was among just a few speakers critical of direct-to-consumer advertising at the two-day hearings. She told the FDA that she believes “direct-to-consumer advertising is persuasion, not information.” She said she would support the idea of requiring a direct link to FDA's online content on a medical product for any Web site that is owned by or supported with funds from the manufacturer (rather than an FDA seal, as has been suggested by PhRMA) and that this link should be in a very noticeable location.

 

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