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© 2015 Venable LLP
June 25, 2015
FDA’s Character Space LimitationsDraft Guidance: What Can You Say to
Keep the Regulators Away?
Kristen R. Klesh
Associate, Venable LLP
202.344.4830
© 2015 Venable LLP
Agenda
• Overview: FDA’s Purpose and Approach to the Draft Guidance
• Setting the Stage: Why this Guidance, Why Now?
• FDA’s Do’s and Don'ts: Draft Guidance Key Points
• Challenges, Options, and Pitfalls: Applying the Draft Guidance toYour Social Media
• Keys to Compliance: Social Media Policies and the Role of thePromotional Review Committee (PRC)
• The Road Ahead: Industry Response and Open Issues
© 2015 Venable LLP
Purpose & Approach to the Draft Guidance
• June 2014 Draft: “Guidance for Industry Internet/SocialMedia Platforms with Character Space Limitations—Presenting Risk and Benefit Information for PrescriptionDrugs and Medical Devices”
• FDA’s “current thinking” on how manufacturers ofprescription drugs and medical devices can:
– provide benefit and risk information consistent with FDA’slabeling & advertising requirements
– when using social media forums with character spacelimitations
– e.g., Twitter, Sponsored Links (Google/Yahoo), etc.
© 2015 Venable LLP
Purpose & Approach to the Draft Guidance (cont.)
In ScopeProducts: Prescription drugs, biologics, and medical devicesSocial Media Platforms:• Only those with character space limitations• Twitter, Sponsored Link Ads—e.g., Google Sitelinks, Others?
Explicitly Out of ScopeSocial Media Platforms:• Product websites, webpages on social media sites (e.g., Facebook
pages), web banners• Mobile AppsPromotions: Reminder ads
© 2015 Venable LLP
Setting the Stage: Why This Guidance, Why Now?
• FDA’s Goal: Apply regulatory requirements in the context of social media
• Long-standing rules & regulations governing drug and device labeling/advertising
– Truthful and non-misleading labeling - FDCA 502(a), 201(n)
– Promotional labeling must include indications for use and risks - 21 CFR 201.100(d),201.105(d) and 801.109(d)
– Prominence and conspicuousness of required labeling – FDCA 502(c)
– Inclusion of certain risk information for advertising of Rx drugs and restricted devices– FDCA 502(n); 21 CFR 202.1; 502(r) and (q)
– “Fair balance” for Rx drug advertisements - 21 CFR 202.1(e)(5)(ii)
© 2015 Venable LLP
Setting the Stage: Why This Guidance, Why Now?
• April 2009 Enforcement – FDA Letters RegardingSponsored Links
– 14 letters issued by DDMAC (OPDP)
– Regarding failure to comply with FDA requirementsin sponsored-link ads
Issues:Issues:• Failure to include established
(generic) name• Broadening of indication• Overstatement of efficacy• Omission of risk information
© 2015 Venable LLP
FDA’s Do’s and Don'ts: Draft Guidance Key Points
• Efficacy
– Benefit information should be truthful and non-misleading
• Risk Information– Include risk information along with any benefit information in the same
communication
• Other Product Information– Brand and generic name
– Dosage information for Rx drugs
© 2015 Venable LLP
FDA’s Do’s and Don'ts: Efficacy
• Accurately describe the indication, including any limitationson patient population/indication
• No broadening!
• No overstatement of efficacy!
• Ex: Headhurtz for severe headache associated with traumatic brain injury in adultsover age 50.
• Ex: NoFocus for mild to moderate memory loss.
• Include risk information with any benefit information
© 2015 Venable LLP
FDA’s Do’s and Don'ts: Risk Information
• If you discuss the product’s benefits, you should adequately convey the risks
• Should be presented with benefit information in each communication
• Most “serious risks” should be included:
– boxed warnings, contraindications, life-threatening or fatal risks
• If none of the above, then the other most significant risks
• Should be comparable to benefit discussion, consider formatting capabilities
• Include link to a landing page providing direct access exclusively to risk information
– Landing page can include hyperlink to PI or brief summary
• Indicate that the landing page is related to risks
• Ex: NoFocus for mild to moderate memory loss; may cause seizures in patients with a seizuredisorder www.nofocus.com/risk
© 2015 Venable LLP
FDA’s Do’s and Don'ts: Other Product Information
• Use of brand name and the established (generic) name of the product
• Established name to the right of, or below, the brand name
• Landing page associated with a hyperlink
• Include the brand/generic name
• For Rx drugs, display at least one dosage form and quantitative ingredient information inconjunction with names
• Common symbols, scientific abbreviations, and punctuation can be used
• FDA-Compliant Example:
– NoFocus for mild to moderate memory loss; may cause seizures in patients with a seizuredisorder www.nofocus.com/risk
SIMPLE ENOUGH, RIGHT?
© 2015 Venable LLP
Challenges: Draft Guidance in Practice
• Can you fit it all in?
• Will consumers get the message?
• Didn’t FDA get it wrong?
• Where is the discussion of pictures?
• Communicating emerging drug safety issues?
• Re-tweets of FDA approvals?
• Are boxed warning drugs out of luck?
Will pharma now lag further behind other industries in terms ofsocial media?
© 2015 Venable LLP
Potential Options, for Now…
• Draft Guidance does not apply to “Reminder Ads” (proprietary name & established name)
• “Disease-awareness ads” outside the scope of FDA’s authority
• “Redirecting” ads?
• “Reminder-like ads” for boxed warning drugs
– proprietary name, established name, “please see” with a link to full prescribing information
© 2015 Venable LLP
Avoiding Potential Pitfalls
Remember….
• “Disease-awareness ads” can become promotional
– Even though “Help-Seeking” guidance was withdrawn in May 2015, FDA’s principles likely stand
– Promotional when used in close proximity or time with a branded ad
– Do not mention product name
– Do not combine with a reminder ad
– Do not link directly to product page
• Reminder ads cannot include indications for use
• Indication must be included for any advertisement, beyond a reminder ad
• Don’t forget to submit drug labeling and advertising using FDA Form-2253 for social mediacommunications that you “own, control, create or influence” ( FDA Post MarketingSubmissions Draft Guidance 2014)
© 2015 Venable LLP
Keys to Compliance: Social Media SOP
• Social Media Policy Considerations:
– Company strategy regarding character space limited social media platforms
o Which platforms? (Twitter, Sitelinks, Pinterest, others)
o Which types of advertisements? (branded vs. unbranded)
– Flexibility to adopt to new technologies
– Use of a “core claims” document (no off-label promotion)
– A “checklist” of requirements for character-space limitation promotions
• All promotional labeling and advertising must be approved
– Made by Company employees
– About Company products
• Addressing challenges with quick turn around/interactive social media
– Expedited process for “pre-approved” promotions by PRC
– Process for elevating unique circumstances/more challenging issues
© 2015 Venable LLP
Keys to Compliance: Role of the PRC
• Tips for a Successful PRC
– Dedicated Roles
– Develop Company risk tolerance
– Concept design for social media
– Process for escalation
– Importance of sticking to deadlines, especially with social media
• Role in Social Media Process
– A PRC member that understands social media platforms
– Timing is everything
– Marketing and Regulatory/Legal on the same page
© 2015 Venable LLP
The Road Ahead
• Industry Reaction
– Challenges with compliance
– First Amendment concerns
– Request for clarity
• FDA Enforcement Trends
– Uptick of FDA enforcement in social media context, even after issuing social media guidance documents
• Open Issues
– When will FDA finalize the draft guidance?
– Impact of the issues raised by stakeholders?
– Are character space limitation communications advertising or labeling (critical for medicaldevices)?
– Can and will FDA-regulated companies continue to shy away from social media?
