Regulatory Focus™ > News Articles > LEAN In? Please Don't, FDA Tells Company in Letter Citing Double Meaning of Ad Campaign

LEAN In? Please Don't, FDA Tells Company in Letter Citing Double Meaning of Ad Campaign

Posted 13 June 2014 | By Alexander Gaffney, RAC

LEAN In? Please Don't, FDA Tells Company in Letter Citing Double Meaning of Ad Campaign

The US Food and Drug Administration (FDA) has issued an Untitled Letter to Citius Pharmaceuticals alleging that the company's website contains materials which create a misleading impression about the safety and efficacy of the company's weight loss drug, Suprenza.

The letter, authored by FDA's Office of Prescription Drug Promotion (OPDP), is only the fourth sent by the agency this year for advertising-related allegations.

But allegations contained within are largely consistent with other Untitled Letters sent in the last several years. OPDP contends, for example, that Citius and its agent, Akrimax, omitted "all of the contraindications and adverse reactions associated with its use" on the product's webpage.

"Furthermore, while the webpage does contain information regarding the risk of co-administration of Suprenza with other drug products for weight loss, it fails to disclose any of the other warnings and precautions associated with the drug," FDA wrote in the letter.

As has been the case in other Untitled Letters, FDA noted that while Citius/Akrimax had added a statement indicating that visitors to the website should click through a link to view the full prescribing information, this addition "does not mitigate the misleading omission of risk information."

OPDP said this omission had, in its eyes, created the impression that Suprenza was safer than it actually is.

FDA Would Rather You Not LEAN In

Elsewhere on the site, the company was promoting the drug using a patient support program it called LEAN, which provides enrolled patients with diet and exercise tips, as well as medication adherence reminders. The site URL (LEANonSuprenza.com) also mentions the program.

But to FDA, the word "LEAN" has two meaning. While the first evokes imagery of a person relying on Suprenza (e.g. leaning against a wall) for support, the second evokes imagery of a person who is "lean" (e.g. "thin"). "It's time to take control … and get LEAN," the website reads.

To FDA, this implication was without merit. "The totality of these claims and presentations misleadingly suggests that patients will become 'LEAN' as a result of therapy with Suprenza," the agency wrote. "However, FDA is not aware of substantial evidence or substantial clinical experience to support this implication."

The letter goes on to also allege that the webpage omits information indicating that the drug is only intended for use in patients with a BMI equal to or greater than 27 (with other risk factors) or 30 (without other risk factors).

FDA has called on Citius to "immediately cease violating" federal regulations and to submit a written response indicating if it intends to comply with FDA's request. The Untitled Letter does not, unlike a Warning Letter, threaten immediate enforcement action against the company.

 

FDA Untitled Letter to Citius

FDA Cached Version of Website


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