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June FDA Warning Letter Updates
The FDA has been hard at work this month, having released an ‘Untitled Letter’ (also known as a Warning Letter) to Citius Pharmaceuticals as well as new FDA social guidelines, which the I&I department has been reading with a fine-tooth comb this past week. Below is a quick summary of the Warning Letter that was released this week. The actual letter and violating promotional materials can be found here.
What we are seeing:
• One pharmaceutical company’s webpage violated three FDA regulations: omission of risk information, unsubstantiated efficacy claims, and omission of material facts.
• The FDA does not consider the statement “Click here for full Prescribing Information” as a ‘catch-all’ for promotional materials that are considered risky when it comes to omission of risk.
• This is a trend that the FDA has been noting a good amount recently.
Medication: Suprenza (phentermine hydrochloride) orally disintegrating tablet
Company: Citius Pharmaceuticals
Indication: Suprenza is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modificationm and caloric restriction in the management of exogenous obesity for patients with an initial body mass index greater than or equal to 30 kg/m2, or greater than or equal to 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).
Materials: Webpage’s homepage
Date: 6/18/14
Violations: Omission of Risk Information, Unsubstantiated Efficacy Claims, and Omission of Material Fact
Summary:
• Omission of Risk Information: Suprenza’s webpage was misleading because it included numerous efficacy claims and presentations for the drug, but it omitted all of the contraindications and adverse reactions associated with its use. This webpage did contain information about the risk of co-administration with other weight loss drug products, but it failed to disclose any of the other warnings and precautions associated with the drug. Furthermore, even though it stated “Click here for full Prescribing Information,” this does not mitigate the misleading omission of risk information.
• Unsubstantiated Efficacy Claims: This webpage uses imagery and language surrounding the word “LEAN,” such as a woman squeezing together lettered blocks that spell “LEAN” and claims like “Stay on course for success with the Suprenza LEAN Program” or “It’s time to take control … and get LEAN.” The use and presentation with the word “LEAN” results in an unsubstantiated efficacy claim because it misleadingly suggests that patients will become “LEAN” as a result of taking Suprenza. However, there are no substantial evidence or clinical trials that support this implication. “LEAN” is commonly understood to mean thin, slim, or slender, which is not associated with any of the clinical endpoint in Suprenza’s studies.
• Omission of Material Facts: Suprenza’s webpage makes representations about Suprenza’s use for weight loss, but it misleadingly omits material information regarding the FDA-approved indication for the drug. Specifically, this webpage failed to disclose the minimum initial body mass index (BMI) that is required for treatment with Suprenza.
Stay tuned for more from the Insights & Innovation department on the FDA’s most recent social guidelines!
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