OPDP letter criticizes drug company for failing to disclose risk info online
The FDA Office of Prescription Drug Promotion (OPDP) on Monday unveiled a new untitled letter sent last week to Michigan-based Rockwell Medical for a webpage that only presents information about the benefits of its drug Triferic (ferric pyrophosphate citrate).
In OPDP’s 7th untitled letter of the year (two warning letters were also issued), the office explains how the company omitted the risks associated with Triferic on its website, which means it failed to provide material information about the consequences that may result from the use of the drug and created a misleading impression about the safety of Triferic.
OPDP also took issue with three claims that the company made that suggest Triferic is safer and more effective than other IV iron replacement products.
“No references were cited to support these claims, and FDA is not aware of data to support claims that Triferic is safer or more effective compared to other IV iron replacement products. While we acknowledge that Triferic is the only FDA-approved iron replacement product administered via hemodialysate, once inside the blood stream, iron delivered by Triferic is used by the body in the same manner as other currently approved iron replacement products,” the letter says.
The company also did not disclose the full indication and limitations of use associated with Triferic.
“This is particularly concerning given claims made on the webpage such as ‘Triferic improves the effectiveness of iron delivery for the majority of dialysis patients. . .’ (emphasis added). This broad claim suggests that Triferic is indicated for patients receiving any type of dialysis, when it is not intended for use in patients receiving peritoneal dialysis and its safety and effectiveness for use in patients receiving home hemodialysis have not been studied,” the agency adds.
The FDA also notes that patients taking Triferic may be at an increased risk of complications, which means the company’s violations are even more concerning from a public health perspective.
RAPS: First published in Regulatory Focus™ by the Regulatory Affairs Professionals Society, the largest global organization of and for those involved with the regulation of healthcare products. Click here for more information.