FDA Rules for using Social Media for Marketing Prescription Products

Duration: 90 Minutes
Social media offers an excellent opportunity for a company to get the word out about its drugs, biologics, medical devices and diagnostic kits. However, FDA regulated products need to follow strict information control; any information distributed to consumers must be approved by FDA.
Marketing Prescription Products
Instructor: Mukesh Kumar
Product ID: 500126
This is hard with social media outlets where information can quickly get out of hand and lead to violation of FDA regulations, and possible penalties on the manufacturers.

The FDA recently held hearings addressing drug companies' use of social media and other online platforms to advertise. FDA also released a guidance document about manufacturers' obligation regarding off-label information available about their products. Another guidance document about use of social media in marketing is expected soon. In addition, FDA issued several letters to manufacturers indicating the rules for using social media.

But there is still much confusion among FDA regulated companies 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 and LinkedIn to get their message out in a way that is compliant with advertising and promotion regulations found in the Food Drug & Cosmetic Act? This presentation 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.

Why Should you Attend:
The seminar 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.

Objectives of the Presentation:
  • 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.
Learning objectives:
At the end of the seminar, the attendees will be familiar with the following:
  • Recent FDA guidance on controlling dissemination of information via social media
  • Common practices for using social media such as Facebook, Youtube, and Twitter
  • Meeting with FDA to discuss social media submissions
  • Trends in FDA review of social media information
  • Do's and Don'ts for managing social media for marketing your product
Who can Benefit:
The following individuals or disciplines will benefit from attending this Webinar:
  • 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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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
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Instructor Profile:
Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex Clinical Research, a full service CRO based in Germantown, MD. His key expertise is in developing Global Regulatory Business Strategies for biomedical product development and his passion is to bring traditional therapies for India, China and the Latin-America to the Western markets. In addition to regulatory expertise, Mukesh is an experienced auditor and a trainer in regulatory and business processes.

Mukesh started his professional career as a research scientist at the NIH, Baylor College of Medicine, Houston, and several premier institutions in India. With more than 11 years of experience in virology, gene therapy, and molecular biology, Mukesh has expertise in biological and combination products. He has been a global Regulatory Affairs Specialist (US, EU, and India) for the last 5 years. He has filed several new-INDs for drugs, biologics and combinations products, NDAs, 510K, PMAs, etc. He has made several hundred FDA submissions, and arranged a number of meetings and responses to FDA comments. In addition, he has had made regulatory submission in the EU and India. Mukesh has reviewed/compiled more than 100 clinical trial protocols and has supervised more than 60 multi-national clinical trials (both under IND and non-IND trials), in the US, Canada, Latin America, Africa, and Asia. In addition to drugs and Biologics, he has extensive experience in medical device and diagnostic product regulatory filings and safety monitoring.

Specialties: Technology transfer, global regulatory strategy, global clinical trials, safety reporting, training, and GLP/GCP audits.

Honors and Awards: US patent awarded "Gene Therapy vectors derived from Sendai virus".

Education: Education: Delhi University - Ph.D., Biochemistry - 1993 – 1997
National Dairy Research Institute - MS, Biochemistry - 1990 – 1993
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