This seminar is intended to help FDA-regulated industry adequately implement FDA-compliant social media practices including direct to consumer (DTC) marketing, advertising and promotional issues including videos to avoid FDA enforcement actions for potential misbranding of prescription drugs (humans and animals), biologics and medical devices.
On June 27, 2014, FDA issued an untitled letter to a pharmaceutical company concerning the firm’s sponsored link on the internet search engine. FDA states:
"The sponsored link provides evidence that the drug is intended for a new use for which it lacks approval, and for which its labeling does not provide adequate directions for use, which renders the drug misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or otherwise makes its distribution violative."
The U.S. Food and Drug Administration (FDA) reviewed the firm’s sponsored link on the Google as part of the FDA’s routine monitoring and surveillance program by the Office of Prescription Drug Promotion (OPDP). The FDA recently sent out various untitled letters to the medical device industry, citing violations for compliance concerning promotion and advertising activities.
It is imperative that firms ensure social media practices under check compliant with the applicable laws and regulations when providing FDA-cleared or approved drug or device information to the public through social media including videos for marketing, advertising or promotional purposes.
In this presentation, the speaker will discuss what to consider and proactively implement applicable elements of requirements while ensuring compliance to the laws and regulations to avoid potential FDA enforcement actions.
This 60 min seminar presentation will provide FDA-regulated industry a great opportunity to understand FDA’s perspectives on social media practices including advertising or promotional videos. You will learn about the various points for compliance that pharmaceutical and medical device firms need to consider when establishing procedures for social media marketing or advertising practices.
- Applicable Laws and Regulations
- FDA’s Current Thinking and Perspectives
- Social Media Guidance(s)
- Advertising and Promotion on Social Media – Twitter, Facebook, Videos (YouTube), WordPress and Blogger
- Considerations for Content and Format
- FDA Enforcements: Recent Cases
- Preventing Non-compliance Marketing or Advertising Practices
- PASS-IT Recommendations: Dos and Don'ts.
Dr David Lim,
President and Principal Consultant ,
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009. Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.
- R&D Scientists, Managers, Directors, and VPs
- Regulatory Affairs and Compliance Professionals
- Clinical Affairs Professionals
- Quality Professionals
- Legal and Compliance Officers
- Marketing Professionals
- Senior Management
- Anyone Interested in the Subject.