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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FDA's 2015 Guidance Agenda - Just Like the 2014 Agenda - Promises Publication of Guidance Regarding Use of Links to 3rd-Party Internet Sites

FDA/CDER has published its 2015 Guidance Agenda (here). Here's what's under the Advertising Category:

• Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs
• Direct-to-Consumer Television Advertisements – DTC Television Ad Pre-Dissemination Review Program for Human Drugs
• Health Care Economic Information in Promotional Labeling and Advertising for Prescription Drugs Under Section 114 of the Food and Drug Administration Modernization Act
• Internet/Social Media Advertising and Promotional Labeling of Prescription Drugs and Medical Devices – Use of Links to Third-Party Sites
• Manufacturer Communications Regarding Unapproved Uses of Approved Medical Products
• Providing Regulatory Submissions in Electronic and Non-Electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs

Some of these guidances -- such as the DTC Television Ad Pre-Dissemination Review Program guidance -- have already been released as draft documents (see, for example, this review). I suppose the FDA is planning on publishing "final" guidance documents based on comments to the draft documents. Or maybe just "revised" draft documents.

I highlighted one item on the list having to do with "Internet/Social Media Advertising" -- Use of Links to Third-Party Sites. This was also on FDA's 2014 Guidance Calendar, but as we know no guidance was issued in 2014.

Perhaps none will be issued in 2015 either. Why not?

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