In addition to criticizing the pharmaceutical company for leaving out risk information from its sales materials and making unsupported superiority claims, the regulator unusually disputed the accuracy of the sources Sciecure used to bolster its assertions.

The regulator’s advertising oversight division warned Sciecure Pharma about materials used to promote its Doral sleeping tablets, writing in a warning letter that by omitting risks associated with Doral, Sciecure’s sales aid deceptively suggests that the product is safer than has been shown. The Office of Prescription Drug Promotion (OPDP) also found the materials contained claims about the drug’s superiority that failed to hold up to the FDA’s close scrutiny.

While the FDA sending a warning letter citing the omission of risk information or the exaggeration of the efficacy of a product in advertising isn’t unusual, the FDA rarely challenges the accuracy of studies referenced in ads. What makes this letter unusual is the focus on the actual reliability of the studies cited in Sciecure’s ads.

The FDA’s letter also addresses a number of “unsubstantiated superiority claims” made by Sciecure, including the characterization of Doral as “unique” and the claims “Discover a surprisingly unique sleep agent” and that the drug is “uniquely selective.”

The regulator contends that the issue is that the drug hasn’t been proven to be safer or more effective than other insomnia treatments, even though the company claims it has a “unique mechanism of action,” which the OPDP notes “had not been demonstrated by substantial evidence,” the key word being “substantial.” Though Sciecure provided evidence of this claim, the FDA contested the accuracy of its sources.

The OPDP wrote that two of the four references were review articles that contained pharmacokinetic information and information about quazepam’s efficacy but didn’t include information on controlled clinical trials. Therefore, there wasn’t anything explicitly supporting that Doral sleeping tablets are superior.  Additionally, the FDA found that one reference was an algorithm that lacked actual abuse data in human subjects and wasn’t validated, and the fourth consisted of a study of the drug in nine healthy volunteers, the main issues being that they didn’t suffer from insomnia and the sample size was too low.

The FDA wrote that the studies don’t account for “substantial evidence” to support that Doral is safer or more effective than other drugs for treating insomnia. The letter states that the studies fail to describe acceptable and well-controlled thorough clinical trials that compare appropriate doses for the drug and comparable products in an appropriate patient population.