Pinnacle cited by FDA for failing to balance risks and benefits in video ads
The US Food and Drug Administration (FDA) says two marketing videos submitted by Pinnacle Biologics make misleading statements about the company's cancer drug Photofrin (porfimer sodium), noting that the lack of details about the drug's full indication and limitations, especially insufficient statements about its risks, could mislead healthcare providers.
The Office of Prescription Drug Promotion (OPDP) issued an untitled letter to Illinois-based Pinnacle, stating that the advertisements failed to provide complete information in Photofrin’s prescription information section about the FDA-approved indications. The agency said that while the videos explained that the drug is intended to treat esophageal cancer, high-grade dysplasia in Barrett’s esophagus, and endobronchial non-small-cell lung cancer, it did not specify the patient populations the drug is intended for, nor its limitations.
"We acknowledge that the indications are presented in the 'INDICATIONS FOR USE' section at the end of the video; however, this is not sufficient to mitigate the misleading impression," according to the untitled letter. "The indications are also presented in small, plain font, for approximately five seconds, in conjunction with the risk presentation, which competes for the healthcare provider’s attention. As a result, it is difficult for healthcare providers to adequately process and comprehend the full indications associated with Photofrin.”
The videos failed to mention the drug’s serious potential risks, including its contraindication in patients with porphyria, according to FDA. More broadly, the agency noted that the company also failed to warn that photodynamic therapy is contraindicated for patients with tumors eroding into a major blood vessel. Regulators added that the ads did not mention that the drug can increase risk for gastroesophageal fistula and perforation, pulmonary and gastroesophageal hemorrhage, photosensitivity, airway obstruction and respiratory distress, and embryo-fetal toxicity.
While the videos included risks about treatment-induced inflammation and photosensitivity, FDA said only about 10 seconds were spent cautioning viewers, which was too brief and failed to elaborate that all patients will be photosensitive or that treatment-induced inflammation may lead to airway obstruction and respiratory distress. The agency said that omitting such risk statements creates a misleading impression of the drug, especially when compared with how the benefits were presented.
"These videos are also misleading because they fail to present information relating to the serious risks and side effects associated with Photofrin with a prominence and readability reasonably comparable with the presentation of information relating to the benefits of the drug," said FDA.
"Specifically, the 'IMPORTANT WARNINGS AND PRECAUTIONS,' which include the serious risks regarding Photofrin therapy, are presented as static, onscreen text, in small, plain font, over approximately five seconds at the end of the video, in conjunction with the indications and most common adverse reactions," the agency added. "In contrast, benefit claims for Photofrin are prominently presented on the screen in large print with colorful animated graphics."
Additionally, FDA noted that in one of the videos, Pinnacle minimized the risk of Photofrin by suggesting that debridement is optional when treating endobronchial tumors, which is not true. The untitled letter is dated 22 June, and the company has 15 days to respond to the agency.
