BIO Submits Comments on Presenting Benefit and Risk Information Via Social Media Platforms with Character Space Limitations

In general, we find the Draft Guidance imposes broad speaker based restrictions on manufacturer communications made via Internet and social media platforms associated with character-space and formatting limitations. As BIO has commented previously, the provision by a manufacturer of truthful and not misleading information about a manufacturer’s products has constitutional protection under the First Amendment. A manufacturer should have flexibility to participate in the scientific and medical dialogue that is occurring constantly via Internet and social media platforms, and to share information about its products on these platforms, so long as it does so in a manner that is truthful and not misleading, even if the precise content may be inconsistent with the FDA recommendations contained in this Draft Guidance.

As BIO has commented previously to FDA, the Internet and social media 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. Because of the uniqueness and rapid evolution of this platform, it is important to apply a practical, flexible 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. BIO is concerned that the Draft Guidance does not fully provide such flexibility, and therefore encourages the Agency to take a more practical approach when issuing any final guidance.