The FDA's ad watchdog, the Office of Prescription Drug Promotion (OPDP), sent untitled letters to Nascent Biotech and Rockwell Medical in November, bringing the total issued for the year to nine. That’s already an uptick from last year’s seven letters and five total for 2017.
The first letter last month went to Nascent Biotech regarding its investigational cancer drug pritumumab. OPDP dinged the biotech for its website, on which Nascent promoted the drug as safe and effective even though it has not yet been approved.
The agency took issue with some of Nascent’s statements, including, “Pritumumab has cured a rare form of brain cancer” and, “After 5 years, patients treated with pritumumab have an overall survival rate of 25-30%, compared to 3% standard therapy, demonstrating antibodies are safe and effective.”
OPDP’s letter says the cure statement is “especially troubling given that brain cancer in general is a disease associated with a poor prognosis.”
The second letter went to Rockwell Medical regarding its iron replacement product Triferic and misleading webpage information. OPDP says that the Rockwell digital site included the benefits of the drug but “fails to include any risk information.”
The agency also disputes several claims on the website that mislead by suggesting Triferic is safer and more effective than other IV iron replacement products, which has not been shown. Comparing the FDA’s snapshot of the misleading pages with Rockwell’s current information, the page is now changed with the named claims removed.
OPDP’s nine letters in 2019 is no record—that would be the 156 letters sent in 1998—but rather is a modest increase, keeping pace with the past few years.