FDA Rules for Use of Social Media in Marketing Regulated Products

Event Information
Product Format
Prerecorded Event
90 Minutes
Product Description

Social Media Sells like Hot Cake. However, when it is about Marketing Regulated Products, it is always wise to be FDA Compliant.

It is not a surprise that social media is one of the best marketing techniques if you want to get the word out about anything or mint profits. However, if you want to market specific medicines, biologics, medical devices and diagnostic kits you will have to follow the rules prescribed by FDA and get it approved by it before you distribute the information to consumers. This is a challenge with social media outlets where information may quickly get out of hand and may violate the FDA regulations – resulting in possible penalties on manufacturers.

Four guidance documents was recently released by FDA that described it to be best practices for use of Twitter-like services, published material, use of web-sites and other public disclosures for sharing marketing and off-label information, and even how to address misinformation at non-company controlled information outlets. In addition, FDA issued several Warning Letters to manufacturers indicating the rules for using social media in the last few years.

There is significant confusion among FDA regulated companies on how to use social media for marketing effectively and still be compliant with regulations. How can medical device, pharmaceutical and other FDA regulated industries use social media channels like Facebook, Twitter, YouTube, Pintrest, web-sites and other social media tools to get their message out in a way that is compliant with advertising and promotion regulations that are found in the Food Drug & Cosmetic Act? This presentation by Dr. Mukesh Kumar will present ways to use social media that are compliant with FDA regulations. Practical regulatory strategies will be suggested to ensure compliance and balanced social media activity.

The conference will discuss the do’s and don’ts for using social media in marketing FDA-regulated products. Common issues, misconceptions, perceptions, and possible solutions will be discussed. In a social media rich environment, manufacturers cannot avoid information dissemination via social media, hence it is prudent to familiarize with the current processes and plan for developments expected in the near future.

Session Agenda:

  • How Direct-to-consumer-advertising (“DTCA”) guidance impacts the use of social media
  • Common ways companies are currently using social media
  • FDA advertising and promotion issues related to social media
  • A structure for analysis of responsibility for promotion in social media
  • Handling unsolicited requests for off-label information
  • Recent trends in FDA enforcement actions involving social media
  • Recent discussions about social media in marketing of FDA-regulated products

Points to be covered:

  • Two kinds of Marketed Products
  • Regulation of Advertisment
  • Mass media and Social media
  • Sites for reliable medical information
  • Increasing enforcement by FDA
  • Off Label information about products
  • Request for off label information
  • How to respond to Unsolicited request
  • Do’s and Don’ts for responding to Unsolicited request
  • Risk with Soliciting information
  • Common complaints
  • Risk with social media as a recruitment tool
  • Do’s and Don’ts of using social media in recruitment strategy
  • What to expect in the near future

Who Should Attend

  • Compliance Management
  • Regulatory Vice Presidents, Directors and Managers
  • Attorneys – In-house or Outside Counsel
  • Senior executives of pharmaceutical and device firms
  • Marketing Management
  • Sales Vice presidents, Directors and Managers
  • Clinical Management

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About Our Speaker

Dr. Mukesh Kumar - Pharma Regulation Expert

Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD (www.amarexcro.com). His key expertise is in regulatory affairs, clinical trials, and multi-national project management for medicinal and diagnostic products. He has been involved in about 100...   More Info
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