FDASM: Initial Draft Guidelines Focus on Social Media Requests for Off-Label Uses

Continuing to update you on progress in this arena. While I was on vacation, FDA finally released their initial partial social media guidelines for comment. Comments are due mid-March.

Here are the files and links to the official documents.

Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices, Draft Guidance (PDF): http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM285145.pdf
Dated December 27, Linked from here: http://www.fda.gov/Drugs/NewsEvents/ucm130958.htm
Comments can be made here: http://www.regulations.gov/#!documentDetail;D=FDA-2011-D-0868-0001

Here are the main takeaways.

1. Draft guidance was released December 27 (not December 30 as some say). Open for public comment for 90 days. Focus of guidance is on off-label use, NOT social media, but includes social media as a component of the communication process.

2. Information on off-label use (use of a drug or device not officially approved by the FDA) cannot be provided at the initiative of the company, but must be specifically and explicitly asked for by the public or consumer.

3. Information must be provided privately (this could be a problem in social media).

4. Information provided must be scientific: “truthful, non-misleading, accurate, and balanced.”

5. Response must be limited to information about the firm’s own products, and must include the FDA-required labeling, clarification about the use not being approved, what are approved uses, safety information & warnings, a bibliography & citations.

6. Public responses should give only contact information and request to discuss privately.

7. Person responding must clearly identify their affiliation, and should be associated with the medical or scientific unit within the company, NOT the marketing or PR folks.

8. What is considered solicited or unsolicited could be tricky.
– One example given is that in the popular crowdsourced video competitions, if someone mentioned an off-label use that will be considered SOLICITED.
– Likewise, reviews by bloggers could be considered solicited if information is provided by the company.

9. Keep a record of all communications.

In short:
Explicit request. Private response. Response must be: FASAD (pronounced “facade”)
* Focused
* Accurate
* Scientific
* Appropriate
* Documented

More information from other sources.

Translating the FDA’s draft guidance
http://www.slideshare.net/paliosaratoga/translating-the-fdas-draft-guidance-10909734

Legal overview

Corporate Law: FDA Proposes Social Media Guidance on Off-Label Drug Use
http://corporatelaw.jdsupra.com/post/15625202908/fda-social-media-guidance-off-label-use

Positive view from pharma marketing

ePharma Rx: My Pollyanna View of Recent FDA Guidance (Wendy Blackburn, Tuesday, January 10, 2012):
http://blog.intouchsol.com/2012/01/my-pollyanna-view-of-recent-fda.html

Small selection of important views & concerns

Storify: Fabio Gratton: FDA Guidance and Social Media:
http://storify.com/skypen/fda-draft-guidance-and-social-media

FDA Issues Draft Guidance on Responding to Unsolicited Requests for Off-Label Information:
http://www.intouchsol.com/insights/articles/01-04-12/FDA_Issues_Draft_Guidance_on_Responding_to_Unsolicited_Requests_for_Off-Label_Information.aspx

FDA Guidance on Responding to Unsolicited Requests for Off-Label Information Via Social Media:
http://pharmamkting.blogspot.com/2011/12/fda-guidance-on-responding-to.html

FDA Guidance on Off-Label Unsolicited Requests:
http://sirensong.sireninteractive.com/compliance/fda-guidance-on-off-label-unsolicited-requests/

WEB EXCLUSIVE: FDA says “Pharma, guide thyself”
http://www.mmm-online.com/web-exclusive-fda-says-pharma-guide-thyself/article/221528/

WEB EXCLUSIVE: Pharmas must step up and lead on off-label, online communications:
http://www.mmm-online.com/web-exclusive-pharmas-must-step-up-and-lead-on-off-label-online-communications/article/221580/

The FDA’s First Social Media Guideline: Off-Label Is On The Mark
http://smhcop.wordpress.com/2012/01/05/the-fdas-first-social-media-guideline-off-label-is-on-the-mark/

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