The QMN Weekly Bulletin
Pharmaceuticals / Inspections and Audits

Imprimis Hit With Warning Letter Amidst Lawsuit

Jan. 19, 2018

The FDA issued Imprimis Pharmaceuticals a warning letter after finding the firm made misleading claims about its eye care products on its website and social media, saying the violations created a public health concern.

Imprimis is currently embroiled in a false advertising lawsuit spearheaded by Allergan, manufacturer of the dry-eye drug Restasis. Allergan claimed the San Diego, California-based company made four misleading statements and unlawfully manufactured drugs under the guise of compounding.

The FDA warning letter targeted Imprimis for misbranding its Dropless, LessDrops, SimpleDrops and Klarity C-Drops products through promotional materials, stating that the violations created public health concerns regarding their safety and effectiveness.

The company’s website made claims of product effectiveness regarding its SimpleDrops product without providing data supporting the claims, the agency said. The website suggested the drops can be used to treat elevated intraocular pressure, but did not mention that an effective treatment regimen using the product would require additional doses of other products — despite the product’s slogan, “One Simple Drop, One Simple Regimen.”

In addition, the agency said the products contained active ingredients with many known risks — such as hemorrhagic occlusive retinal vasculitis and ciliary body hemorrhage — but the firm’s website included no associated risk information.

Healthcare providers are unable to make informed decisions about the products for patients due to the lack of information, the agency said.

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