Spectrum

FDA and FTC: Enter at Your Own Risk

Summers are normally quiet in Washington. Traffic thins out. Cabs are more available, and Capitol Hill can feel like a ghost town. But this summer, the story was different.

Health care reform kept the government and the media buzzing with details about the proposed overhaul – debate over a public option, discussion of non-profit coops, and concerns over access and quality of care.  While the conversation on Capitol Hill focused on one angle of health care reform, the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) chiseled away on another. Quietly, each released new proposals that portend major changes for how pharmaceutical and medical device companies advertise, interact with the consumer, the patient, in the future.

Risk Disclosure

In May, the FDA released “Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion.” The 27-page document described new factors the FDA could consider when evaluating how companies disclose side effects of prescription drugs. Under the new guidance, labels and promotional materials would be under new scrutiny in the FDA’s effort to protect consumers against false or misleading information. Add into the mix the new emerging modes of media – blogs, social networks, Pay Per Click (PPC) ads – and you get an entirely new maze for communication professionals to navigate for their pharma clients.

Endorsements, Testimonials

In similar fashion, the FTC released proposed rule revisions that would require that companies/marketers/bloggers provide full disclosure of relationships with advertisers and product companies.  As John Bell, President of the Word of Mouth Marketing Association (WOMMA) said, “That’s how we preserve the integrity of social media communications.”

While the FTC rules aren’t targeted at drug companies, the message for communication and marketing professionals couldn’t be clearer: Proposed FTC guidelines are a sign of what’s to come – a major sweep of changes in the way drug companies and communication professionals can use endorsements and testimonials to market products.

This is an industry that tends to be reluctant to try new things in the media world, and there are clear reasons why. Regulatory rules create unique challenges in the Web 2.0 environment. We also know that if the proposed FTC rules are put into place, pharma will no longer be able to buy or subsidize endorsements. It would appear the industry just lost one more tool in their tool box. Or did it? If you want to join us in looking at the glass half full, think of it this way. It presents us with a chance to find new and better ways to get messages out.

At least that’s our story, and we’re sticking to it.

Erica Anderson, Senior Digital Strategist

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