FDA offers industry guidance on product info on social media
"Ongoing challenges in technology transform medical products," which is why the FDA has proposed two draft guidances for industry with recommendations on how manufacturers can accurately communicate online about drugs and medical devices, according to a blog post by Thomas Abrams, director of the Office of Prescription Drug Promotion in the agency's Center for Drug Evaluation and Research.
The goal is to make sure that information provided by drug and device companies is accurate and wil help patients make well-informed decisions, he wrote.
One guidance includes recommendations for the presentation of risk and benefit information using internet and social media sources with character space limitations. Despite the limitations, "benefit claims in product promotions should be balanced with risk information. And companies should provide a way for consumers to gain direct access to a more complete discussion of risks associated with their products."
The other guidance relates to companies that choose to correct third-party information related to their own prescription drugs and medical devices. Manufacturers that want to correct misinformation should do so "in a clearly defined portion of a forum on the internet or social media, whether the misinformation is positive or negative."
The guidances are a response to requests for best practices from companies and other stakeholders, wrote Abrams. "FDA sees social media as an important resource for industry and is committed to developing additional guidance for drug and device manufacturers that outline the agency's current thinking."
Read the guidance and how to submit comments by the Sept. 16 deadline.
proposed two draft guidances for industry with recommendations to help manufacturers and their representatives accurately communicate online about prescription drugs and medical devices. - See more at: http://blogs.fda.gov/#sthash.4rnr0reX.dpuf