Dear Sir/Madam:
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the FDA Draft Guidance on “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional
Media for Prescription Human and Animal Drugs and Biologics” (Draft Guidance). BIO represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products, thereby expanding the boundaries of science to benefit humanity by providing better healthcare, enhanced agriculture, and a cleaner and safer environment.
I. General Comments
Social media and the internet represent a unique and rapidly evolving platform for not only communicating significant health information to the public, but also providing an important resource for people to discuss and seek out information about their health,
diseases and treatments. Social media and the internet provide users with a greater ability to control, alter, and respond to promotional messages and other information, often in the form of user generated content (UGC) that frequently occurs in real-time. As FDA acknowledged in the Draft Guidance, “although some interactive promotional media are substantially similar in presentation and content to certain traditional promotional media, such as print media, FDA recognizes that in other cases they possess certain unique technological features and offer novel presentation and content features.” Because of the uniqueness and rapid evolution of this media, it is important to apply flexibility in the regulatory approach to enable companies to participate more fully and develop responsible policies and practices to help advance and encourage the safe use of their products.
We welcome FDA’s acknowledgement of the unique characteristics and logistical considerations presented by content available through the internet and social media. In addition, BIO appreciates the FDA’s general proposition in this Draft Guidance that companies are “not responsible for UGC that is truly independent of the firm;”and also FDA’s flexibility in proposing practical approaches to fulfilling the regulatory requirements, such as how to meet post-marketing reporting requirements.
We look forward to FDA’s planned release of additional guidance concerning internet promotion, including guidance on the use of links and the correction of third-party misinformation on internet and social media platforms. It is important for firms to have the regulatory clarity needed not only to accurately and responsibly fulfill their regulatory reporting requirements, but also to be able to appropriately utilize all available media platforms on which medical professionals and the public seek and receive health information.
