The U.S. Food and Drug Administration (FDA) has chastised Sciecure Pharma for weak evidence in their advertisements for Doral sleeping pills, Wall Street Journal reports. In a letter issued on October 29th, the agency took issue with claims that Doral is superior to other sleeping aid tablets.
In touting Doral as better than other sleep aids, the four-page long advertising spread cited various studies to convey this point. The FDA Office of Prescription Drug Promotion, however, highly disapproved of these references because they lack “substantial evidence” to support their claims. The agency also rebuked the ads for failing to mention information about the risks of using Doral.
In particular, the FDA 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 explicitly support the claim that Doral sleeping tablets are better than other sleeping aids.
According to the letter, the algorithm in a third study “purportedly differentiates the likelihood of abuse and relative toxicity among 19 compounds,” including Doral. The FDA, however, points out that this algorithm is not validated and does not involve any data on actual abuse in humans. The ad cited a fourth study that had inadequate statistical power and an appropriate patients population, the FDA said.
The agency stated that the studies “do not describe adequate and well-controlled head-to-head clinical trials comparing appropriate doses” for Doral and other sleep aids in an appropriate patient population to support the claims made in the ad. Because of this, the FDA said, they do not count as “substantial evidence” to claim that Doral is safer or more effective than other products used to treat insomnia.
WSJ reports that it is not uncommon for pharmaceutical advertisements to violate FDA regulations. A pharmaceutical marketing consultant told the WSJ that in 40 percent of letters sent by the FDA drug promotion involve overstating the benefits and omitting the risks.