The long-awaited US Food and Drug Administration guidance on social media for drug companies has arrived, and it includes information on how to discuss the risks and benefits of drugs on a social media platform like Twitter and how to correct misinformation present on websites like Wikipedia, Pharmalot's Ed Silverman writes.
A tweet promoting the benefit of a drug — the brand and generic name of which must be included — needs to also incorporate the top risk associated with it as well as a link to a site that describes all possible harms, Bloomberg reports. FDA offered this as an example of such a tweet: "NoFocus (rememberine HCl) for mild to moderate memory loss-May cause seizures in patients with a seizure disorder www.nofocus.com/risk." This tweet, which refers to a fictional drug, Bloomberg notes, uses 134 of the 140 characters allowed by Twitter.
"I think this is clear enough guidance you'll start seeing more tweets," Lori Leskin, a partner at the New York law firm Kaye Scholer, tells Bloomberg. "It's the more significant drugs that do have black box warnings, that do have more significant risk, that are used in limited populations that this won't be appropriate for."
The guidance also suggests that drug companies may also correct misinformation on third-party sites, provided they provide balance information and credits the company, company employee, or contractor with the fix, Silverman says.
"The information should not be promotional and should be factually correct. This is not an opportunity for a company to tout its drugs," Tom Abrams, from the Office of Prescription Drug Promotion at FDA, tells Pharmalot. "The information [being added or revised] should be consistent with the FDA-approved [product] labeling and for it to be effective, you want it posted right by the misinformation."