The FDA sent an untitled letter to QOL Medical regarding the Sklyde emails, accusing the company of misleading the impression about the indications for its rare disease drugs.
FDA officials sent a letter (PDF) to QOL after reviewing two promotional emails from Scryed. One letter is intended for use in children and the other letter is intended for use in adults. The FDA approved Sucraid, an oral sucrase replacement therapy, in 1998 for the treatment of congenital sucrase isomaltase deficiency (CSID). QOL acquired this product in 2003.
The email challenged by the FDA included the following text: “Try Scryde” and “Do you have patients suffering from unresolved IBS-like symptoms such as gas, bloating, diarrhea, and nausea?” “Maybe CSID?”
The quality of life claims suggest that Scryde can be used to treat irritable bowel syndrome (IBS) because of symptoms that overlap with CSID, the FDA said. The agency also accused QOL of implying that Scryed can treat all causes of CSID, specifically because information about indications such as target age and focus on treating sucrase deficiency was missing from the body of the email.
The FDA noted that the full display at the bottom of the email includes information about quality of life. But the information is presented in a small, plain font after “intervening text or eye-catching graphics or color,” which is not enough to reduce the misleading impression, the agency said.
By focusing on eye-catching graphics and the impact of color, Untitled Letter echoes previous notices of other forms of advertising. In recent months, the FDA has sent untitled letters to companies including Argenx and Bayer over “attention-grabbing visuals” in direct-to-consumer television ads. The letter to QOL reflects the application of a similar regulatory approach to promotional email.
The FDA also reprimanded QOL for omitting important facts about the risks associated with Scryde. Not only did QOL omit some details from the prescribing information, it also allegedly presented the information in a different order. The FDA said the risks associated with Scryed were minimized by sorting out misleading information.
In 2024, QOL and the company’s CEO Frederick Cooper agreed to pay $47 million to resolve false claims claims. Prosecutors accused QOL of working to “expand the use of Scryed to off-label diseases like IBS” (PDF).
