Imprimis Pharmaceuticals FDA Warning (2017)

Detailed Analysis

False Claims and Regulatory Violations

The claims on your website and other promotional materials establish that these products are drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 321(g)(1), because they are intended for use in the cure, mitigation, treatment or prevention of disease.  As explained further below, your firm’s website and twitter account make false or misleading claims regarding “Simple Drops” and “Klarity C-Drops” – specifically, they represent that these products are made with FDA approved components or are FDA-approved, when that is not the case.  In addition, your firm’s website makes false or misleading claims about your “Dropless,” “LessDrops,” and “Simple Drops” products by omitting important risk information, including side effects, contraindications, or

In addition, your website and other promotional materials contain claims  regarding the effectiveness of your “Simple Drops” products that are not supported by the effectiveness data for the active ingredients in certain “Simple Drops” products.  The claims on your website and in other promotional materials suggest  that patients can treat elevated intraocular pressure with “One Simple Drop” according to “One Simple Regimen,” but fail to disclose that a patient would need to take more than one eye drop product pursuant to multiple, different dosing regimens in order for the active ingredients in those “Simple Drops” to be effective throughout the day.  This is concerning because patients can lose vision in the form of visual field loss (also known as glaucoma) if elevated intraocular press

False or Misleading Claims

Potential Health Risks

Mark BaumImprimis Pharmaceuticals Inc.12264 El Camino Real, Suite 350San Diego, CA 92130

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.  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 ingredients3,  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.  Appendix I to this Warning Letter includes descriptions of these and other known risks associated with the active ingredients in your products and the techniqu

Your “Simple Drops” brochure states that your products are “Compounded with FDA-approved drug components.” In addition, a press release, “Imprimis Pharmaceuticals to Launch its Simple Drops Combination Glaucoma Drops at Leading Cataract & Refractive Surgery Medical Meeting,” May 4, 2017, states, “Simple Drops consist of high-quality sterile FDA-approved components that are made and dispensed from Imprimis’ PCAB-accredited and FDA-inspected facilities.” Furthermore, on October 25, 2017, you tweeted the following on your Twitter account, @markbaum4:  “EyewireTV – Compounded Cyclosporine Introduced eyewiretoday.com/?v=mwloh #bauch lomb #dryeye #fdaapproval/clearance #imprmispharmaceuticals,” suggesting your compounded cyclosporine product – “Klarity-C drops” -- is FDA approved. Because your “

Regulatory Context

Thus, the webpage and other promotional materials misbrand your “Dropless,” “LessDrops,” “Simple Drops,” and “Klarity C-Drops” products within the meaning of the FD&C Act and make their distribution violative.  21 U.S.C. 352(a), (bb); 321(n); 331(a).

A drug is misbranded if its labeling, including promotional labeling, is false or misleading in any particular.  21 U.S.C. 352(a).  In addition, a compounded drug is misbranded if its advertising or promotion is false or misleading in any particular.  21 U.S.C. 352(bb).  In determining whether labeling or advertising is misleading, section 201(n) of the FD&C Act requires that it be taken into account whether the labeling or advertising fails to reveal facts that are material in light of representations made or with respect to consequences that may result from the use of the drug as recommended or suggested by the labeling or advertising or under such conditions of use as are customary or usual.

For the reasons discussed above, your webpage and other promotional materials misbrand the “Dropless,” “LessDrops,” “Simple Drops,” and “Klarity-C drops” products within the meaning of the FD&C Act, which makes their distribution violative. 21 U.S.C. 352(a), (bb); 321(n); and 331(a).