The U.S. Food and Drug Administration on Tuesday issued proposed guidelines for the pharmaceutical and medical device industries for posting information on social media networks and correcting misinformation posted by others.
The long-awaited guidance would effectively limit the amount of product advertising a company can do on sites where character space is limited, such as Twitter.
The proposal would require companies to post both the benefits and the main risks associated with a product, potentially with a hyperlink taking the reader directly to a more detailed list of risks.
To illustrate, the FDA provided the example of a hypothetical memory loss drug, NoFocus.
An acceptable tweet could read: "NoFocus for mild to moderate memory loss; may cause seizures in patients with a seizure disorder www.nofocus.com/risk"
The FDA would require that companies spell out the exact indication for the product. In the case of NoFocus, for example, the drug is for "mild to moderate memory loss." It would not be sufficient to describe NoFocus as a "memory loss" drug.
"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," the proposed guidance states.
Simple "reminder" promotions in which only the name of the product is displayed would be allowed.
The FDA also outlined proposed guidance for companies seeking to correct misinformation posted by independent third parties and in chat rooms.
The agency said it would not require a full balancing of risks and benefits that are normally required as long as the corrections are clearly defined, accurate and not misleading.
"The FDA does not intend to object if the corrective information does not satisfy otherwise applicable regulatory requirements regarding labeling or advertising," the guidance states.
Such leeway would not be granted if an incorrect posting was made by an employee of the firm or by an affiliate firm. Neither could a company monitor a discussion on its own website and remove or edit postings that portray a drug in a negative light while adding comments that portray it in a positive light.
A company may either correct legitimate misinformation directly on the forum or it may submit the correction to an individual blogger or author of a web page.
The FDA said it would not hold a company accountable if a particular author or website failed to correct the misinformation.
If an author disputes the company's correction about, for example, a product's side effects, a company may respond with specific information from the label. But if it were to respond with slogans and examples of patient profiles from its marketing campaign, the slogans and patient examples would "go beyond providing corrective information."