OPDP cites drugmaker for misleading email claims
The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) sent an untitled letter to QOL Medical to “false or misleading” claims made in promotional emails for its congenital sucrase-isomaltase deficiency (CSID) treatment Sucraid (sacrosidase) oral solution.
The untitled letter continues a surge in advertising and promotion enforcement by FDA that began last year, when the agency sent more than 100 warning and untitled letters to drugmakers citing them for false or misleading promotional claims about their products. The increase in activity follows a protracted lull in OPDP enforcement activity; for most of the past decade, the office has sent 10 or fewer enforcement letters per year.
FDA accused the Vero Beach, FL-based company of making a “misleading impression” about the drug’s indication, which is to treat sucrase deficiency in adults and children 5 months or older with CSID. The drug works by helping patients who lack the sucrase enzyme digest table sugar, which reduces gastrointestinal symptoms like watery diarrhea, abdominal pain, and bloating.
FDA challenged some claims in the emails such as “Do you have patients suffering with unresolved IBS-like symptoms, including gas, bloating, diarrhea, and/or nausea?” and “Could it be CSID?”
The agency said these claims and presentations suggest that due to overlapping symptoms with CSID, Sucraid can be used to treat irritable bowel syndrome (IBS), which is not true. Additionally, the emails suggest that Sucraid can address all the contributing factors of CSID, but this is also incorrect.
FDA noted that while the company provided the full indication of the drug, this information was displayed in “small plain font” at the bottom of the email. In contrast, the preceding text featured “eye-catching graphics and/or colors.” FDA concluded that this presentation of information was “not sufficient to mitigate the misleading impression.”
QOL also failed to disclose important information about the risks associated with Sucraid. The company downplayed or omitted severe hypersensitivity reactions related to the drug, such as rash and itching (pruritus). Additionally, the precautions section did not mention that blood glucose levels should be monitored and adjusted for patients with diabetes mellitus.
FDA added that the manner in which the company ordered the risk information “misleadingly minimizes the risks” associated with the drug. “Specifically, risk information pertaining to the ADVERSE REACTIONS section of the PI is presented prior to the risk information pertaining to the PRECAUTION section of the PI (i.e., Increased Blood Glucose Concentrations in Patients with Diabetes Mellitus), thereby framing the subsequent risk information as less serious,” FDA said.
As a result, FDA requests that the company cease any further misleading promotional communications for Sucraid and to notify the agency of any actions the company takes to address any promotional violations.
