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.
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