November 10, 2014
By Mark Terry, BioSpace.com Breaking News Staff
Controversy over how much information about risk is included when a drugmaker distributes sales aids swirled Monday, after The Wall Street Journal said that the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) has been taking increasing aim at companies that engage in misrepresentative advertising.
In one case, the FDA sent a lengthy and pointed letter October 29 to Monmouth Junction, N.J.-based Sciecure Pharma Inc. regarding misrepresentation in its advertising. The letter focuses on the company’s advertisements for sleep medical Doral (quazepam).
In part the letter states, “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. The sales aid also omits the warnings and precautions regarding benzodiazepine withdrawal syndrome, the need to evaluate for co-morbid diagnoses, severe anaphylactic or anaphylactoid reactions, abnormal thinking and behavior changes, and worsening of depression. The omission of these serious risks associated with the drug is further exacerbated by the claims on pages two and four characterizing Doral as having a ‘favorable safety profile.’”
Unfortunately, drug marketing information has a history of overstating efficacy or not fully providing risk information. In The Wall Street Journal article today, pharmaceutical marketing consultant John Mack says that more than 40 percent of letters the FDA send similar to the one to Sciecure focus on those two factors.
What makes this particular letter more unusual is a focus on the actual veracity and accuracy of the studies cited in the advertisements. The letter specifically points to four references cited in the product descriptions to support their marketing claims. Two of the references were review articles, rather than clinical studies; one of the articles cited an algorithm that “lacks actual abuse data in human subjects and has not been validated.” The fourth reference was based on nine healthy subjects and “lacks adequate statistical power and an appropriate patient population to draw any conclusions.”
The letter went on to say, “The four cited references do not describe adequate and well-controlled head-to-head clinical trials comparing appropriate doses and dose regimens for Doral and the comparator drugs in an appropriate patient population that would be necessary to support claims of efficacy or safety superiority for Doral. Therefore, the references cited do not constitute substantial evidence to support the suggestion that Doral is safer or more effective than other products for the treatment of insomnia.”
At least part of the issue is that the marketing materials were aimed at physicians and misrepresented the scientific basis for the medication. The FDA requested that Sciecure immediately stop violating the FD&C Act with specific citations, and respond in writing on or before Nov. 13, 2014.
