House Bill Would Give FDA 18 Months to Finalize "One-Click Rule" Guidance: ROFLMAOYSST

On May 20, 2015, Rep. Billy Long (R-Mo.) introduced to the U.S. House of Representatives a bill (H.R. 2479) that would "direct the FDA to clearly regulate meaningful, truthful and non-misleading communication of product information on social media."

Specifically, the draft of the bill (find it here) states that the FDA should revise its regulations and guidances to "recognize that [sponsors of medical products] may use the Internet to:

• "disseminate, in character-limited applications, truthful, introductory information about medical products, including the name of such products and their approved uses; and 


• "provide additional information about the safety and effectiveness of the medical products using information that is hyperlinked to such introductory information; and for regulatory purposes, treat hyperlinked information ... as if the information appeared in introductory information [i.e., the original character-limited text, meaning tweet]."

This, of course, is the "one-click rule," which has been hotly debated for years in pharma marketing circles. In fact, I was among the first observers to point out that the "one-click rule" as described above should be allowed. Let me explain...

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