Vol. 13, Issue No. 4: April 2014 – EXECUTIVE SUMMARY Pharma Finds Little to Like in Recent FDA Social Media Guidance Delete, Limit, & Clarify Says Industry
The comments are in! As usual, the pharma industry waited until the last minute to submit comments to FDA Docket 2013-N-1430 regarding “Guidance for Industry: Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics.”
This article provides highlights from submissions by Novartis, Shire, the Pharmaceutical Research and Manufacturers of America (PhRMA), which represents the country’s leading pharmaceutical research and biotechnology companies, the Biotechnology Industry Organization (BIO), Klick Health, the Social Media Compliance Council (SMCC), the Coalition for Healthcare Communication (CHC), and the Digital Health Coalition (DHC), and other interested parties.
Topics include (partial list):
- Links to All Comments
- Figure: Focus of Comments Submitted
- What Constitutes “Influence?”
- FDA vs. “Journalism Ethics”
- Scope of Control Over 3rd Party Sites
- Off-Label Adjacency
- PhRMA Questions Legality
- Impact on Earned Media Coverage
- Burdensome Paperwork!
- User-Generated Content
- To Moderate or Not Moderate?
- Employee-Generated Content
- A Social Media “Laboratory”
- Possible Real-World Scenarios
- FDA Intern: The Quest for Social Media Guidelines
- What About Pre-Approval Social Media?
Download the full text PDF file here:
www.pharma-mkting.com/news/pmnews1304-article01.pdf The Sorry State of Pharma Mobile Health Apps Lack of Security, Continuity and Platform Standardization, Distribution Challenges, Poor ROI
At a recent eyeforpharma Philadelphia 2014 Summit, Carolyn Gauntlett, Senior Innovation Consultant with IMS Health, gave an interesting presentation titled “How to Make Sure You’re Getting the Most Out of Your mHealth App Development.”
This articles summarizes some major points made in that presentation as well as data from the report “Patient Apps for Improved Healthcare: From Novelty to Mainstream” published by IMS Institute for Healthcare Informatics.
Topics include (partial list):
- Some Docs Prescribe More Apps Than Pills
- So, Why Hasn’t Mobile Health “Exploded?”
- More Apps, Less Meds?
- Few mHealth Apps Are Worthy
- Figure: Health App Functionality Score Distribution
- The Pharma App Black Hole
- Poor ROI
Download the full text PDF file here:
www.pharma-mkting.com/news/pmnews1304-article02.pdf
