FDA hits out at 'particularly concerning' false marketing claims from ImprimisRx

The FDA has raised deep concerns with ImprimisRx over “false and misleading” promotional materials for its eyedrop therapy Pred-Moxi-Brom, which is used to manage pain and inflammation after surgeries.

The U.S. regulator sent a warning letter to the Californian speciality pharma for claims it made in several journals last year. The company claimed that the drug uses FDA-approved meds and has superior efficacy to rivals. ImprimisRx also made questionable safety statements.

Pred-Moxi-Brom is made up of three drug compounds: prednisolone acetate, moxifloxacin and bromfenac. In one journal promotion from last year, ImprimisRx claimed that “unlike off-the-shelf prescription medications made by the major drug manufacturers, compounded prescription drugs are specifically created and ‘made to order’ from two or more existing medications already approved by the U.S. Food and Drug Administration for safety and efficacy.”

The FDA has taken issue with this, saying that while the three drugs do have individual FDA approvals, “it is our understanding that you use bulk drug substances—not approved drug products—in compounding Pred-Moxi-Brom.” These bulk substances are not FDA-approved, so the company cannot make these claims, the FDA said.

On the efficacy side, the company made further misleading statements including that “Pred-Moxi-Brom represents a new and higher standard in the treatment of postsurgical pain and inflammation” and that its drug has “demonstrated quality that is equal to, if not higher than, drugs produced by the major pharmaceutical companies.”

The FDA said, not so fast: “This presentation misleadingly suggests that Pred-Moxi-Brom is superior to multiple individual FDA-approved drug products, but it does not provide support for these claims,” the agency said in the warning letter.

“The FDA is not aware of any data to support the suggestions that Pred-Moxi-Brom increases patient compliance, improves treatment outcomes or is of higher quality compared to other drug products.”

And the misleading claims continued for safety, which were more serious for the FDA. In another journal promotion, the company said: “Although generic medications are available, they can potentially cause unknown adverse effects. Pred-Moxi-Brom virtually eliminates all these challenges with just one drop.”

But the FDA said it was “unaware of any evidence that supports the safety claims” for the drug, and that ImprimisRx failed to communicate any risk information associated with the product. “This is particularly concerning,” the FDA noted, in light of “the many known risks” associated with the active ingredients in the combo drug, which the company knows well, given that it is in fact on its website.  

All these misleading claims violate the FDA’s rules, it said in the letter. As usual in these cases, the company has 15 days to sort out these issues, stop making these claims and tell the FDA exactly how it will do that. If it doesn’t, it will get hit by “further regulatory action.”

This is, in fact, the second time the FDA has raised concerns with the company. Back in 2017, the agency sent a previous warning letter saying the company had been “omitting important risk information” in social media and online posts.