Section 1121 of the Prescription Drug User Fee Act (PDUFA) states: “Not later than 2 years after the date of enactment [signed into law on 9-July-2012], FDA shall issue guidance describing FDA policy regarding Internet promotion, including social media, of medical products regulated by FDA” (see here).
I call this the “Social Media Guidance Cliff” because if FDA does not meet this deadline it is technically breaking the law of the land and that would be a first.
On January 14, 2014, the FDA published what appeared to be a hastily-cobbled document titled “Guidance for Industry Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics.”
Although this document is focused on when and how pharma companies should submit forms to the FDA to fulfill regulatory requirements for postmarketing submissions, it does offer some insights regarding FDA’s thinking on regulating “interactive media” and according to Stephen King, a Public Affairs Specialist at FDA’s Center for Drug Evaluation and Research (CDER), it does address some sections of 1121 (see “FDA Publishes First Piece of Long-Awaited Social Media Guidance“).
Section 1121 does NOT specify that the FDA must publish ALL the guidelines it promised after the November, 2009, public hearings by the July 3, 2014, deadline. Consequently, the January, 2014, guidance may be enough to satisfy the non-specific “letter of the law.”
But what about all the other promised guidelines?
FDA’s “Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2014” includes these promised guidances under the “Advertising” category:
- Internet/Social Media Platforms with Character Space Limitations: Presenting Risk and Benefit
Information for Prescription Drugs and Medical Devices - Internet/Social Media Platforms: Correcting Independent-Third Party Misinformation About
Prescription Drugs and Medical Devices - Internet/Social Media Advertising and Promotional Labeling of Prescription Drugs and Medical
Devices – Use of Links
It seems inconceivable that the FDA will be able to address all THREE before Independence Day. But at least it can say it satisfied Section1121.
