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Regulatory Focus™ > News Articles > In Unusual Letter, FDA Dismantles Company's Drug Superiority Claims

In Unusual Letter, FDA Dismantles Company's Drug Superiority Claims

Posted 06 November 2014 | By Alexander Gaffney, RAC

In Unusual Letter, FDA Dismantles Company's Drug Superiority Claims

The US Food and Drug Administration's (FDA) drug advertising oversight division has sent a warning to a pharmaceutical company regarding materials used to promote a drug, saying the materials omitted "important risk information" and contained claims about the drug's superiority that did not hold up to the agency's close scrutiny.

The Letter

In its so-called "Untitled Letter" to New Jersey-based Sciecure Pharma, FDA's Office of Prescription Drug Promotion (OPDP) said it takes issue with the company's sales material promoting Doral (quazepam), a drug approved by FDA for the treatment of insomnia.

In particular, OPDP said the sales materials failed to include risk information that consumers might find important. "The four page sales aid includes numerous claims and presentations regarding the benefits of using Doral for the treatment of insomnia, yet omits all of the contraindications for the use of Doral," agency regulators wrote. That conflicts with FDA's standard requirement that companies include a "fair balance" of benefits and risks in all promotional advertising and materials.

The ad also included a statement characterizing the drug as having a "favorable safety profile," but did not include any mention of Doral's potential to cause withdrawal symptoms, severe anaphylactic reactions, changes in behavior or worsening depression—symptoms commonly associated with many benzodiazepines and other central nervous system (CNS) drugs.

Though the company's sales piece asks readers to "see accompanying full prescribing information" located at the company's website, OPDP said this information did not serve to "mitigate the omission" of important risk information in the advertisement.

"By omitting serious and common risks associated with the drug, the sales aid misleadingly suggests that Doral is safer than has been demonstrated," OPDP wrote.

FDA's letter also takes notice of several "unsubstantiated superiority claims" made by Sciecure. The company characterizes Doral as "unique" several times in its advertising. "Discover a surprisingly unique sleep agent," it claims on one page. The drug is "uniquely selective," it claims on other pages. Even the sales piece's use of imagery—a white sheep representing Doral standing among four other black sheep—served to advance this point.

FDA Disputes Evidence of Superiority

The problem, FDA said, is that the drug hasn't been shown to be any safer or more effective than other approved treatments for insomnia, despite its "unique mechanism of action," which OPDP notes "had not been demonstrated by substantial evidence." The key word there is "substantial." While evidence of this claim was provided, FDA disputed the accuracy of those sources—an unusual action for the regulator.

FDA's evidentiary take-down is worth reading in full:

"Four references are cited to support these claims. Two of the references cited are review articles which provide general descriptions of the pharmacodynamics, pharmacokinetics, and efficacy of quazepam and other benzodiazepines rather than descriptions of well-controlled clinical studies.

A third reference … provides an algorithm that purportedly differentiates the likelihood of abuse and relative toxicity among 19 compounds, including quazepam. However, the “algorithm” lacks actual abuse data in human subjects and has not been validated.

Finally, the fourth reference … is a study evaluating cognitive- neuromotor performance based on a DSST in nine healthy subjects that lacks adequate statistical power and an appropriate patient population to draw any conclusions.

The studies, FDA concluded, were not sufficient "to support claims of efficacy or safety superiority for Doral."

FDA's letter goes on to also chide the company for omitting "material information" about the drug, including information from the FDA-approved labeling, and for failing to submit the ad for review using Form FDA-2253. The company was asked to stop distributing the sales materials immediately and respond to FDA regarding its proposed course of action.


FDA Untitled Letter

Sales Aid

Doral Medication Guide


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