Drugs

False/Misleading Claims for Imprimis Rx Compounded Drugs: FDA

FDA says a review of promotional materials in ophthalmology professional journals for Imprimis Rx’s compounded Pred-Moxi-Brom (prednisolone acetate 1%, moxifloxacin 0.5%, and bromfenac 0.075%) found that they make false or misleading claims about the drug and thus misbrand the drug product. A 6/30 Warning Letter says the violations are concerning from a public health perspective because they create a false or misleading impression about the drug’s safety or effectiveness. “This is especially concerning in light of the many known risks associated with the active ingredients in this drug product, as reflected in Imprimis Rx’s own product information Web site and the prescribing information for FDA-approved drug products containing the same active ingredients, as well as potential safety risks of using these drug products together,” the letter says.

The letter discusses false or misleading claims regarding FDA approval, unsubstantiated superiority claims, and false or misleading risk presentation. The company lists "possible indications" for its drug as postoperative ophthalmic inflammation and postoperative eye pain.

FDA says that in 2017 it sent the firm a Warning Letter based on a company Web site and social media posts that misbranded several of its other products by omitting important risk information and otherwise making false or misleading claims about the products’ safety and efficacy. “We are concerned that Imprimis Rx is continuing to promote its products in a manner that similarly fails to adequately and truthfully convey risk and efficacy information about the products, despite concerns previously expressed by FDA,” the letter says.

Imprimis Rx was told to respond with specific steps it has taken to address the violations, with copies of related documentation that includes a listing of all other promotional communications for Pred-Moxi-Brom that contain representations such as those described in the letter and an explanation of any plan for discontinuing such communications or ceasing distribution of the drug.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome