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FDA Blasts Company for Sleep Drug Ad

Promotional claims omit risk information

The FDA’s 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 scrutiny.

In a letter to New Jersey-based Sciecure Pharma, the FDA’s Office of Prescription Drug Promotion (OPDP) said it takes issue with the company’s sales material promoting Doral (quazepam), a drug approved 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 the 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 drugs.

Further, although the company’s sales piece asks readers to “see accompanying full prescribing information” located at the company’s website, the OPDP said this information did not “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,” the OPDP wrote.

The 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.

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

Specifically, the FDA made the following comments:

  • “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 [digit–symbol substitution test] in nine healthy subjects that lacks adequate statistical power and an appropriate patient population to draw any conclusions.”

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

The agency’s letter goes on to chide Sciecure for omitting “material information” about the drug, including information from the approved labeling, and for failing to submit the ad for review.

The company was asked to stop distributing the sales materials immediately and to respond to the FDA regarding its proposed course of action.

Sources: Regulatory Affairs Professionals Society; November 6, 2014; and FDA; November 6, 2014.

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