By using this site, you agree to the Privacy Policy and Terms of Use.
Accept
Health Works CollectiveHealth Works CollectiveHealth Works Collective
  • Health
    • Mental Health
    Health
    Healthcare organizations are operating on slimmer profit margins than ever. One report in August showed that they are even lower than the beginning of the…
    Show More
    Top News
    improving patient experience
    6 Ways to Improve Patient Satisfaction Within Hospitals
    December 1, 2021
    degree for healthcare job
    What Are The Health Benefits Of Having A Degree?
    March 9, 2022
    custom software development is changing healthcare
    Digital Customer Journey Mapping and its Importance for Healthcare
    July 21, 2022
    Latest News
    Grounded Healing: A Natural Ally for Sustainable Healthcare Systems
    May 16, 2025
    Learn how to Renew your Medical Card in West Virginia
    May 16, 2025
    Choosing the Right Supplement Manufacturer for Your Brand
    May 1, 2025
    Engineering Temporary Hospitals for Extreme Weather
    April 24, 2025
  • Policy and Law
    • Global Healthcare
    • Medical Ethics
    Policy and Law
    Get the latest updates about Insurance policies and Laws in the Healthcare industry for different geographical locations.
    Show More
    Top News
    Can Thinking Younger Make You Live Longer?
    April 20, 2011
    Image
    Obesity’s Outlook Unchanged
    June 13, 2011
    When It’s An Emergency Elderly Not Treated As Well in Hospitals
    July 16, 2011
    Latest News
    Building Smarter Care Teams: Aligning Roles, Structure, and Clinical Expertise
    May 18, 2025
    The Critical Role of Healthcare in Personal Injury Recovery: A Comprehensive Guide for Victims
    May 14, 2025
    The Backbone of Successful Trials: Clinical Data Management
    April 28, 2025
    Advancing Your Healthcare Career through Education and Specialization
    April 16, 2025
  • Medical Innovations
  • News
  • Wellness
  • Tech
Search
© 2023 HealthWorks Collective. All Rights Reserved.
Reading: Double Trouble: Two New FDA Draft Guidances on Social Media
Share
Notification Show More
Font ResizerAa
Health Works CollectiveHealth Works Collective
Font ResizerAa
Search
Follow US
  • About
  • Contact
  • Privacy
© 2023 HealthWorks Collective. All Rights Reserved.
Health Works Collective > eHealth > Social Media > Double Trouble: Two New FDA Draft Guidances on Social Media
Social Media

Double Trouble: Two New FDA Draft Guidances on Social Media

Chen Sirkis
Last updated: June 20, 2014 5:28 am
Chen Sirkis
Share
5 Min Read
Image
SHARE

 

Contents
Two NEW FDA DRAFT Guidances On the Use of Social Media and Online Promotions of Devices and DrugsDraft Guidance I: Correcting independent third-party misinformation about prescription drugs and medical devicesDraft Guidance II: Internet/social media platforms with character space limitations

 

ImageTwo NEW FDA DRAFT Guidances On the Use of Social Media and Online Promotions of Devices and Drugs

After five years in the making, the FDA is on a roll. Following the publication of the previous draft guidance on the use of social media for “post-marketing submissions for post marketing submissions of interactive promotional media“, the agency has published two new guidances of conduct of medical device and pharma companies in social media.

The first seems easier to understand and implement than the second.

More Read

On the Road Again for Cancer Connections
How The Medical Device Industry Lobbies
Health Apps and Real Time Consults
The Future of Medicine: Incredible Innovations to Expect by 2064
Free Physician Rating and Medical Q&A Forum at Avvo.com

Draft Guidance I: Correcting independent third-party misinformation about prescription drugs and medical devices

Imagine the following: You work as a sales representative in a medical device company. It has come to your attention that a blogger wrote a post that contains inaccurate information about your medical device. On the same day, you learn of a patient that has shared personal experiences with your device on a forum and misinformed other patients about the device’s use. You believe that the way that both these stories are represented may be harmful to the public health. You start typing away at your answer, informing the blogger and forum members of their mistakes. FDA guidance suggests that you should stop first and ask yourself: is it worth your while?

The FDA maintains that you have no obligation to correct any information published by a third party who is not under the firm’s control or influence. This is regardless of whether the firm owns or operates the platform on which the communication appears.

The FDA leaves this to the discretion of the pharma company or medical devices company. If the company chooses to engage in the correction of misinformation, it needs to adhere to certain approaches outlined in the guidance – for instance it cannot only correct negative misinformation written about the medical device while ignoring an overstatement of the benefits of the product.

Download complete draft FDA social media guidance on Correcting Independent Third-Party Misinformation about Prescription Drugs and Medical Devices.

 

Draft Guidance II: Internet/social media platforms with character space limitations

This FDA draft guidance is more comprehensive than the first and seems more complicated to execute. The guidance describes the FDA’s current thinking about how medical devices and drug manufacturers and marketers should present benefit and risk information of promotional materials in channels that have “character space limitations” (mainly Twitter, and “sponsored links” on search engines such as Google). The guidance does not include platforms such as Facebook and YouTube where there are no space limitations.

The main takeaway: Risk information must appear alongside risk information. Both must be presented in the same message. The FDA clearly states that having risk information on only a Twitter cover photo is insufficient and that main risk information should be included in the short message as well. If a medical company concludes that adequate benefit and risk information, as well as other required information, cannot all be communicated within the same character-space-limited communication, then the firm should reconsider using that platform for the intended promotional message. To many companies, this will be the case. To make matters more complicated, a link should be should be supplied that brings visitors to a page that is solely dedicated to risk information.

The guidance on how promotional materials should be prepared and presented goes on at length in its recommendation – using the example of a fictional drug they call NoFocus (And some people say that the FDA has no humor….).

The use of so many examples shows how complex this field is and the extent to which the FDA does not have a clear grasp of the way it should be managed.

Download complete draft FDA social media guidance on Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices

The post Double Trouble: Two New FDA Draft Guidances on Social Media appeared first on CadenSee by Chen Sirkis

TAGGED:FDA
Share This Article
Facebook Copy Link Print
Share

Stay Connected

1.5kFollowersLike
4.5kFollowersFollow
2.8kFollowersPin
136kSubscribersSubscribe

Latest News

Clinical Expertise
Building Smarter Care Teams: Aligning Roles, Structure, and Clinical Expertise
Health care
May 18, 2025
Grounded Healing: A Natural Ally for Sustainable Healthcare Systems
Grounded Healing: A Natural Ally for Sustainable Healthcare Systems
Health
May 15, 2025
Learn how to Renew your Medical Card in West Virginia
Learn how to Renew your Medical Card in West Virginia
Health
May 15, 2025
Dr. Klaus Rentrop Shares Acute Myocardial Infarction heart treatment
Dr. Klaus Rentrop Shares Acute Myocardial Infarction
Cardiology
May 13, 2025

You Might also Like

Best Practices During Product Recalls Include Social Media

September 28, 2011
Image
Social Media

Why Knowing Your Audience Is Critical To Healthcare Social Media Marketing

April 15, 2012

Interview with Paul Wicks, PatientsLikeMe, Keynote Speaker at Doctors 2.0 & You Conference

February 16, 2012

GAO: FDA Can’t Monitor Device Recalls

June 22, 2011
Subscribe
Subscribe to our newsletter to get our newest articles instantly!
Follow US
© 2008-2025 HealthWorks Collective. All Rights Reserved.
  • About
  • Contact
  • Privacy
Welcome Back!

Sign in to your account

Username or Email Address
Password

Lost your password?