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Sciecure Rebuked by FDA over Faulty Evidence in Doral Sleeping Pill Ads

Nov 12, 2014

A recent advertisement for Sciecure's Doral sleeping pills sparked concerns by the U.S. Food and Drug Administration. According to the Wall Street Journal, the agency took issue with evidence cited in the ad.

WSJ reports that it is not uncommon for the agency to chastise companies over misleading advertisements. A pharmaceutical marketing consultant told WSJ that more than 40 percent of FDA drug promotion's letters are for overstating the benefits while downplaying the risks. Taking issue with the accuracy of studies referenced in ads however, is unusual, according to Regulatory Focus.

In a letter dated October 29th, the FDA Office of Prescription Drug Promotion noted that the advertisement claimed Doral was superior to other sleeping aids and cited several studies to support this point. However, the FDA said the studies referenced lacked “substantial evidence” to back this claim. In particular, the letter stated that “two of the references cited are review articles which provide general descriptions of the pharmacodynamics, pharmacokinetics, and efficacy [of the drug] and other benzodiazepines, rather than descriptions of well-controlled clinical studies.” These sources do not lend actual evidence to show that Doral is superior.

The agency also criticized the algorithm in a third study, which “purportedly differentiates the likelihood of abuse and relative toxicity among 19 compounds,” including Doral. The FDA said the algorithm is not validated and does not contain actual abuse data in human subjects, WSJ reports. There was inadequate statistical power in a fourth study, which also lacked an appropriate patient population.

According to the letter, the ad cites studies that “do not describe adequate and well-controlled head-to-head clinical trials comparing appropriate doses” for Doral and similar products in an appropriate patient population to support claims. For these reasons, the FDA says, they do not count as “substantial evidence” that Doral is safer or more effective than other sleep aids.

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