Switzerland-based IBSA Institut Biochimique SA recently got a thumbs-down from the Food and Drug Administration over a Facebook ad for its hypothyroidism drug, Tirosint, that the agency deemed false and misleading.
The page featured a logo and a statement that “If you have just been diagnosed with hypothyroidism or are having difficulty controlling your levothyroxine blood levels, talk to your doctor about prescription Tirosint, a unique liquid gel cap form of levothyroxine.”
Despite the fact that the drug requires a black box warning against taking Tirosint for weight loss or obesity and is contraindicated for use by children and those with adrenal gland problems, the company failed to mention any information about possible side effects.
Writing in an “untitled letter” that “Tirosint is associated with a number of serious risks,” the FDA declared the ad “misleading because it makes representations about the efficacy of Tirosint, but fails to communicate any of the risks associated with its use. . . . By omitting the most serious and frequently occurring risks associated with Tirosint, the Facebook webpage misleadingly suggests that Tirosint is safer than has been demonstrated.” IBSA also failed to mention that the drug isn’t always the right choice for transient hypothyroidism.
Accordingly, the letter ordered an immediate halt to IBSA’s Facebook marketing, that would in any way violate the Food, Drug and Cosmetic Act.
To read the FDA’s letter, click here.
Why it matters: The FDA has dipped its toe into regulating drug companies that advertise on social media, but could be wading in as the weather warms up. The letter to IBSA follows the agency’s first enforcement effort when it warned AMARC Enterprises about its Facebook activity. The dietary supplement maker ran afoul of the FDA when it “liked” a consumer testimonial about one of its products. The user wrote that AMARC’s supplement “enabled me to keep cancer at bay without the use of chemo and radiation.” Drug companies should prepare for an increase in agency action following the release of proposed social media guidelines earlier this year.