What Happened on Day 1 of the FDA Hearings – Our Quick and Easy Summary

By Kimberley Irish

Interesting information presented at the FDAs public hearing regarding the promotion of FDA-regulated medical products using the Internet and social media tools.

Day 1, Thursday, November 12: The FDA listened to a parade of pharmaceutical manufacturers, marketers, Internet companies, and nonprofit health advocacy groups. There were many presentations loaded with survey data and many different opinions expressed regarding what the new guidelines should look like. The following are some of the key takeaway facts and opinions:

  1. The ultimate goal of everyone involved is that the promotion of medicine is truthful, scientifically accurate, and meaningful (with a balance of benefits and risks). This is not new but the medium is and it comes with its own unique set of challenges.
  2. Transparency is key and will help determine who is accountable for all information presented. All those who work for or are paid by a pharmaceutical company should disclose such information prominently and early on, not at the end of a Web site.
  3. There is a real need for accountability for content and guidelines. Rohit Bhargava presented a model for accountability called the 3 Cs model (creation, collaboration, and compensation). If the pharmaceutical manufacturer created the content, worked in collaboration with a third party on the content, or offered compensation to the person creating the content, then the pharma manufacturer is responsible for monitoring the content, ensuring it meets the current regulatory guidelines, and ensuring that it is accurate.
  4. Pharma manufacturers should not be responsible for policing the entire Internet. See accountability above, it would be impossible to monitor every bit of information on the Internet regarding a single product.
  5. Most people would like to see the return of the “one-click rule. Some advocates felt that “one click was too far away for important safety information (ISI). David Zinman of Yahoo! suggested that rich media with ISI scrolls satisfy present criteria for fair balance. The consensus was that patients understood links and how to access them. In addition, the ability to point and click is a unique and a superior method for making the connection to important risk information. For a 60-second television ad, a company does not need to include all of the risks of a product but must present the risks relative to the claims and provide adequate provision for getting the complete risk information (eg, 1-800 number or an ad in a nationally circulated magazine). This way of getting risk information is more difficult than clicking on a prominent link and being brought to the information.
  6. There are many people getting information about their health from many different online sources. Ninety-one million Americans use the Internet monthly, accessing 1,700 health sites. Fifty percent of people are using social media for health information, but only 46% are finding it useful and only 35% believed the information was truthful.

Some interesting suggestions from the speakers

  1. PhRMA suggested the development of an FDA symbol and universal language on all online advertising as a consistent way of linking to important safety information.
  2. John Mack from Pharma Marketing News suggested using brand-specific hashtags on all pharma company micro-blog posts about a product as a way for the FDA to monitor adherence to the new guidelines regarding social media.
  3. Google implied that new sponsored links following the FDAs crackdown on sponsored links actually have less transparency and relevance and, therefore, are worse than they were before the FDA warning letters. They went as far as to suggest a new standardized format for sponsored links that would include brand, generic name, indication, one line for benefit information, one line for risk information, and “one-click to important risk information. They even suggested a way to do sponsored links for products with a boxed warning, which I think has a snowballs chance in¢‚Ǩ¬¶. Well you know where I am going with that.



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