Perspective on FDA regulation of direct-to-consumer pharmaceutical marketing

OTOi, Life Sciences Team | One to One Interactive
November 4, 2005

The US Food and Drug Administration has primary responsibility for overseeing the promotion of regulated medical products to consumers and healthcare professionals. In September 2005, they announced their intention to hold a series of public hearings on various topics related to the direct-to-consumer (DTC) promotion of pharmaceuticals and devices.

Amongst several topics, the hearings examined the rapid emergence of the Internet and other non-traditional direct-to-consumer communication channels and explored potential regulatory implications. The hearings are expected to serve as a critical input for the FDA and legislators as they evaluate DTC promotion and potential changes to the current regulatory environment.

On November 1, 2005, One to One Interactive joined with representatives from Pfizer, the American Medical Association (AMA), the American Society of Health-System Pharmacists (ASHP), Kaiser Permanente, the American Advertising Federation (AAF), the Pharmaceutical Research and Manufacturers of America (PhRMA), and other leading organizations in Washington to address the hearings.

Click here to access a PDF version of the firm's presentation which summarizes James Gardner's testimony and highlights our belief that the interactive channel is a critical tool for millions of Americans and that any additional DTC regulation by the FDA must reflect its unique differences versus conventional media.

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