BIO Submits Comments on Correcting Independent 3rd Party Misinformation Via Social Media
<p>
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Internet Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices.”</p>
In general, the Draft Guidance provides comprehensive information about FDA’s proposed recommendations for companies seeking to correct misinformation on the Internet and social media platforms generated by independent third parties. There are, however, several points on which BIO requests further consideration or elaboration.
We appreciate FDA’s recognition that public health may benefit when firms correct misinformation about their products. Indeed, conversations purporting to contain accurate information about biopharmaceutical products are already happening and prevalent on social media platforms. BIO members seek assurance of FDA’s flexibility regarding manufacturer participation in these already-existing conversations, in order to provide balanced, researched, and accurate information regarding their products. Without flexibility, the alternative is a potential continuation of the chilling effect on manufacturer participation, despite the fact that firms likely have the most accurate and up-to-date information and resources for the public at large. It is in the best interest of the public for FDA to assure firms of flexibility, given the realities of the platforms on which these conversations are already taking place.
We further note that, 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’s participation in the scientific and medical dialogue, by communicating truthful and not misleading corrective content about its products, is entitled to broad protection even if the content or distribution method may be inconsistent with this Draft Guidance.
Nonetheless, we also appreciate the recommendations provided in this guidance for firms to exercise this right to voluntarily correct misinformation created or disseminated by independent third parties.