Last month, the FDA released draft guidance on social media and internet platforms with character space limitations and a separate draft guidance for correcting misinformation posted online. Some of us had been waiting for these guidelines for five years or more.

I discussed these guidance documents with Kathi Browne in a Google+ Hangout on Air:

FDA Social Media Changes that May Affect Healthcare

Key takeaways:

  • The draft guidance makes use of Twitter and platforms like Google Ads extremely unattractive, because the vast majority of the "real estate" must be given over to brand and generic names, indications for use, benefits, risks, and a link to fuller information about risks.
  • The FDA addressed itself to short-form communication without considering the way in which it is used most effectively – not as a canvas for ads, but as a forum for conversation.
  • Unbranded tweetchats, Facebook pages, and the like were OK before the draft guidance was issued, and they still are.
  • The correction of misinformation guidance lowers the regulatory bar for corrections (vs. marketing messages that must meet higher standards and may be subject to pre-review).
  • The misinformation guidance does not require a drug or device manufacturer to address all misinformation online about its products. Corrections must be focused responses to what others put out there on line, and should link to fuller information where appropriate, but corrections should not include or link to promotional material.
  • The misinformation guidance delineates an area of opportunity for drug and device manufacturers.

Please take the time to watch the whole video if you are interested in this subject, and let's continue the conversation in the comments section or in another online forum.

Interestingly, the FDA has already taken action based on its subregulatory draft interpretations of the statutes and regulations that are applicable in this arena. Specifically, it has sanctioned two companies – one, for branded use of Google Ad Words that did not comply with relevant requirements (the drug in question was being promoted as a cure for a condition, when in fact it has been approved only as a treatment for symptoms; the ad omitted risk information; the established name for the drug was not used; and the ad was not submitted to the FDA), and the other, for website, Twitter and Facebook claims about products sold over the counter that have never been subject to FDA review; and liking Facebook posts endorsing one or more of its products — which the FDA views as "misbranded" "new drugs" since the seller is making claims as to efficacy in treating certain conditions even though they had never been approved by the FDA.

The FDA is accepting comments on the draft guidance through mid-September.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting