The latest proof that the FDA is not giving social media outreach wiggle room, even though communications guidelines are not due out until this summer: an untitled letter to Institute Biochimique and US partner Akrimax Pharmaceuticals over a Facebook page for its hypothyroidism drug Tirosint.
The agency’s advertising watchdog unit, the Office of Prescription Drug Promotion, slapped the company in its February reprimand for failure to “communicate risk information,” and omission of material facts. This combination qualifies the page as being false and misleading.
Exacerbating the regulator’s displeasure is that this is a drug with a boxed warning, a format the FDA sometimes requires to highlight adverse events, contraindications or matters that require a prescriber’s additional attention.
In this case, the drug is not indicated for transient hypothyroidism during recovery of subacute thyroditis, should not be used to treat obesity or for weight loss, and should be avoided by patients with acute myocardial infarction or uncorrected adrenal insufficiency.
OPDP says leaving this information out “misleadingly suggests that Tirosint is safer than has been demonstrated.”
Online surveillance is not a new gig for the bad-ad watchdog, and recent analysis by regulatory consultancy Porzio Life Sciences indicates that these two pharmaceutical companies hit the sweet spot of transgressions, in that omission of material facts was a major focus of the unit’s 2013 list of violations, as were online communications.
Searching for the Tirosint Facebook page on Google turned up a page with purported patient conversations about the drug at press time, while an in-Facebook search for this page generated a list of drug information from sources including WebMD and the FDA.
Don’t miss a free webinar on Thursday, March 13 at 2PM on what the FDA’s recent draft guidance means for social media in pharma. Register HERE.