FDA regulators published a pair of new draft guidances this week to provide clarity on its stance regarding online communication in challenging situations, especially via character-constrained channels such as Twitter or when responding to misinformation posted online.
The 1st guidance offers recommendations on communicating through mediums that have character space limits, referencing Twitter’s 140-character Tweets and paid search links offered by web browsers, but also attempting to look to future channels. The guidance doesn’t impose any enforceable standards, but reflects “the Agency’s current thinking on a topic.”
Restricted online channels pose a particular challenge when medical device and drug makers attempt to talk about new products, especially where companies are required to give equal space to risk and benefit communication alike. The FDA left it up to companies to decide what online media to opt into, but cautioned that device makers may do best to shy away from constrained platforms if they can’t find a way to balance both risk and benefit in their messages. Indeed, it cannot be denied that the Internet plays a vital role in getting healthcare to more people. With the help of an online marketing agency or, in Asia, an SEO Singapore, health providers can certainly expand their reach.
“Regardless of the platform, truthful, accurate, non-misleading, and balanced product promotion best serves the public health. For some products, particularly those with complex indications or extensive serious risks, character space limitations imposed by platform providers may not enable meaningful presentations of both benefit and risk,”according to the FDA. “If an accurate and balanced presentation of both risks and benefits of a specific product is not possible within the constraints of the platform, then the firm should reconsider using that platform for the intended promotional message.”
The FDA’s 2nd new draft guidance looks at ways in which companies can respond to “user-generated content” posted online by independent 3rd parties. Companies are not required to respond to misinformation, whether positive or negative, generated by users, but “FDA has determined it may benefit the public health for firms to correct misinformation about their products,” the agency said.
Given constraints in avenues for response, depending on the type of online forum where the misinformation is posted, the FDA offered to loosen some of the regulatory requirements regarding usual medical product communication.
“If a firm voluntarily corrects misinformation in a truthful and non-misleading manner and as described in this draft guidance, FDA does not intend to object if the corrective information voluntarily provided by the firm does not satisfy otherwise applicable regulatory requirements regarding labeling or advertising, if any,” according to the draft guidance document. “If a firm chooses to respond to misinformation about its products using non-truthful or misleading information or in a manner other than that recommended in this draft guidance, however, FDA may object if the information provided by the firm does not comply with applicable regulatory requirements related to labeling or advertising, if any.”
Both guidances are open until September 16, 2014, for public comment before the FDA issues a final version of its recommendations.
