FDA Issues Warning Letter to Imprimis for False and Misleading Claims

The FDA has issued a warning letter to Imprimis Pharmaceuticals, claiming the maker of compounded drugs made false or misleading claims about its products. The FDA stated that Imprimis made misleading claims regarding its “»Simple Drops” and “»Klarity C-Drops” formulations on the company’s website and Twitter account.

Specifically, the FDA accused Imprimis of claiming that these products are “made with FDA approved components or are FDA-approved,” when that is not the case. In addition, Imprimis’ website makes false or misleading claims about its “»Dropless,” “»LessDrops,” and “Simple Drops” products by omitting important risk information, including side effects, contraindications, or consequences that may result from their use, and by presenting efficacy claims about its “Simple Drops” products while omitting material information, according to the FDA.

“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,” according to the FDA letter. “This is especially concerning in light of the many known risks associated with several of the active ingredients in these products, as reflected in the prescribing information for FDA-approved products containing the same active ingredients, and the technique by which your website indicates your “Dropless” products should be administered. These risks include, but are not limited to, hemorrhagic occlusive retinal vasculitis (HORV) and ciliary body hemorrhage.”

“The omission of risk information suggests that the drugs do not bear the risks that are known to be associated with the active ingredients in these products and the technique by which your website indicates that your “Dropless” products should be administered. The absence of risk information on your website is especially problematic from a public health perspective,” the letter stated.

The FDA told Imprimis it should take prompt action to correct the violations and that failure to do so could result in legal action.

In a statement provided to Eyewiretoday.com, Imprimis said it is complying with the FDA request.

“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. 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.”

To read the full letter, dated December 21, 2017, click here.

In August, Allergan sued Imprimis, accusing the company of unlawfully manufacturing and selling unapproved new drugs and violating the Lanham Act and state (California) law by engaging in false and misleading advertising and promotion of their unapproved new drugs.

“Biopharmaceutical companies like Allergan have a duty to put the safety of their patients first. This commitment is the cornerstone of our manufacturing, marketing and advertising of our FDA-approved products. Today, we have brought suit against companies that we believe stand in stark contrast to that commitment,” according to an Allergan press release.

Imprimis responded by calling Allergan’s lawsuit “frivolous,” claiming the maker of Restasis was trying to squash competition.

Imprimis CEO Mark L. Baum stated in a press release in September, “Allergan’s illegal, abusive, and anticompetitive actions aimed at maintaining its obscenely high drug prices reveal its true socially unconscious values.”

Below is a list of Imprimis’ products named in the FDA letter:

• “Dropless” products

o Tri-Moxi (triamcinolone acetonide, moxifloxacin hydrochloride), 15/1mg/ml
o Tri-Moxi-Vanc (triamcinolone acetonide, moxifloxacin, vancomycin), 15/1mg/10mg/mL
o Moxi (moxifloxacin hydrochloride), 5mg/mL

• “LessDrops” products

o Pred-Gati-Nepaf (prednisolone acetate, gatifloxacin, nepafenac), 1/0.5/0.1%/mL
o Pred-Gati (prednisolone acetate, gatifloxacin), 1/0.5%/mL
o Pred-Nepaf (prednisolone acetate, nepafenac), 1/0.1%/mL

• “Simple Drops” products

o Tim-Brim-Dor PF 2  (timolol/brimonidine/dorzolamide), 0.5/0.15/2%
o Tim-Brim-Dor-Lat PF (timolol/brimonidine/dorzolamide/latanoprost), 0.5/0.15/2/0.005%
o Tim-Dor-Lat PF (timolol/dorzolamide/latanoprost), 0.5/2/0.005%
o Tim-Lat PF (timolol/latanoprost), 0.5%/0.005%

• “Klarity C-Drops” product (cyclosporine 0.1%/chrondroitin sulfate)