For Industry: Using Social Media
The Internet and various social media platforms have increasingly enabled drug and device manufacturers to more actively engage with consumers and healthcare providers.
In November 2009, FDA held a Part 15 public hearing to gather comments and questions from our stakeholders (e.g., industry, health care providers, consumers, patient groups, Internet vendors, advertising agencies, and other interested parties) on how FDA can best provide guidance on the promotion of FDA-regulated medical products (including prescription drugs for humans and animals, prescription biologics, and medical devices) using the Internet and social media tools.
The public hearing was instrumental in providing an opportunity for our stakeholders to comment. In addition to the 77 live presentations, we received 72 comments to the docket—a major collaborative effort by both the Agency and our stakeholders.
OPDP carefully considered input received both from outside and within the Agency and has since released four draft guidances that address various topics related to the public hearing. We look to continue our work in this ever-evolving landscape.
Guidances
- Internet/Social Media Platforms with Character Space Limitations Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices
- Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices
- Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics
- Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices
FR Notices
- Internet/Social Media Platforms with Character Space Limitations: Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices; Reopening of the Comment Period
- Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices; Reopening of the Comment Period
- Draft Guidance for Industry and Staff: Internet/Social Media Platforms with Character Space Limitations; Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices
- Draft Guidance for Industry and Staff: Internet/Social Media Platforms; Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices
- Draft Guidance for Industry on Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics; Availability
- Draft Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices; Availability
Additional Resources
- Social Media Guidance Webinar - July 10, 2014
- Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools
- FDA Voice Blog: FDA Issues Draft Guidances for Industry on Social Media and Internet Communications About Medical Products: Designed with Patients in Mind