FDA Input On Medical E-Marketing Sought

An advocacy group wants digital marketers of medical products to comply with Food and Drug Administration rules on healthcare advertising.

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As people increasingly turn to the Internet for medical advice, the Center for Digital Democracy has requested that the Food and Drug Administration work with the Federal Trade Commission on development of rules regarding digital media marketing of pharmaceutical products.

In a letter sent to FDA commissioner Margaret Hamburg and deputy commissioner Josh Sharfstein, the CDD commended the FDA for conducting a recent inquiry into social media and the digital marketing of drugs, but said these avenues for medical marketing present consumer protection concerns.

Currently, the FTC is mulling over the distinctions between personal and non-personal information in the online context, and is developing best practices on how to protect consumer privacy online with a report expected to be released this summer.

"We urge the FDA to integrate the issues raised by the forthcoming FTC report and comments into its own recommendations on social media," said Jeff Chester, the CDD's executive director and author of the letter.

Once established, the FDA's guidelines could have far-reaching effects on how prescription drugs are presented online, and how online health information sites interact with consumers.

These issues have raised several concerns that the CDD outlined in its letter as well as offering several recommendations. These include:

  • Current FDA guidance on the presentation of risk information for medical products should not be compromised. If an e-marketing tool is unable to satisfy basic consumer-protective measures it should be considered inappropriate for the promotion of pharmaceutical products.

  • Individuals seeking sensitive health-related information for themselves or members of their families may now be exposed to covert online data collection designed to identify, track, profile, and target consumers. Data-driven forms of personalized interactive marketing require the FDA to assess whether new safeguards are required for the promotion of pharmaceuticals and other products.

  • Drug or device companies should not be engaged in any promotion of their products via direct e-mail, text messaging to consumers, blast e-mail, or e-mail listservs, chat rooms, or social networking bulletin boards that are operated by third parties.

  • Disease or condition-specific channels that consumers turn to for information about their personal health matters should clearly disclose any relationships they have with health advertisers. The FDA needs to evaluate the relationship between these online health information portals and their advertisers.

Last November, the FDA held a two-day public hearing, followed by a public comment period, on the use of the Internet and social media tools to promote FDA-regulated medical products which include prescription drugs for humans and animals, prescription biologics, and medical devices.