Medical device and pharmaceutical companies must include risk information along with benefit claims in all online postings about their products, even when Twitter limits them to 140 characters, according to new draft guidance from the U.S. Food and Drug Administration.
Companies must also provide a way for consumers to obtain more in-depth risk information, according to the guidance.
"FDA recommends that firms first carefully consider the complexity of the indication and risk profiles for each of their products to determine whether a character-space-limited platform is a viable promotional tool for a particular product, and then take the factors, recommendations and hypothetical examples outlined in this guidance document into account when developing benefit and risk presentations," according to the guidelines. "The public health is best served when risk and effectiveness information about drug and device products is clearly and accurately communicated."
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