FDA warns Imprimis for false, misleading promotional claims

The FDA issued a warning to Imprimis Pharmaceuticals regarding false or misleading information in promotional materials for its Dropless, LessDrops, Simple Drops and Klarity C-Drops products.

The website and Twitter account for Imprimis include information claiming Simple Drops and Klarity C-Drops are made with FDA-approved components or are FDA approved, which is incorrect, while omitting risk information about the Dropless, LessDrops and Simple Drops products, according to a warning letter dated Dec. 21, 2017, and addressed to Imprimis CEO Mark Baum.

“These violations are concerning from a public health perspective because they create a false or misleading impression about the safety and effectiveness of these products,” the letter, which is signed by Steven E. Porter Jr., director of the FDA’s Division of Pharmaceutical Quality Operations IV, reads.

Tri-Moxi-Vanc, one of the Dropless products, contains triamcinolone, moxifloxacin and vancomycin, a drug that has recently been associated with a risk for hemorrhagic occlusive retinal vasculitis, yet the company’s promotional materials include no mention of this and other risks associated with the compounded formulas.

“Because these risks are not described, the website does not enable healthcare providers to make informed decisions about whether the benefits of your products outweigh the risks for their patients or to inform patients of appropriate monitoring that could minimize consequences of these potential adverse events,” the letter said.

In addition, the promotional materials mislead prescribers regarding the treatment regimen of the Simple Drops products with claims that include “One Simple Drop. One Simple Regimen” and “Simple Drops include multiple medications into one drop bottle for your patient’s convenience.”

These claims fail to disclose the fact that an effective treatment program using the Simple Drops products would require additional doses of certain products, according to the FDA.

The company was told to take “prompt action” to correct the violations discussed in the letter and to notify the office in writing within 15 days of Dec. 21 of the specific steps taken to do so.

A statement from Imprimis to Healio.com/OSN said the company has responded to the FDA’s warning and intends to fully comply.

“Ophthalmologists are very sophisticated consumers and use Imprimis because we help them produce exceptional outcomes for their patients. That said, we have responded to the FDA and intend to fully comply,” the statement reads. “We do not expect our response to affect our ability to serve our nearly 2,000 ophthalmologist customers, continuing to provide them with affordable, innovative and high-quality compounded formulations made to the highest federal standards.” – by Rebecca L. Forand

Reference: www.fda.gov