The FDA has accused Pinnacle Biologics of creating videos that make it hard for healthcare professionals to “adequately process and comprehend the full indications” for a cancer drug.
Officials sent (PDF) Pinnacle an untitled letter after reviewing the company’s videos on the use of Photofrin, a photodynamic therapy. Physicians inject the treatment and, 40 to 50 hours later, apply a red laser light to the tumor area to activate the therapy. Activation releases oxygen radicals that can kill tumor cells.
Pinnacle sent the FDA two Photofrin videos for review. The videos introduce Photofrin as a treatment for esophageal cancer, high-grade dysplasia in Barrett’s esophagus and non-small cell lung cancer (NSCLC), the FDA said, but omit specific patient populations and limitations.
The FDA ruled that the omission created a misleading impression about the drug’s approved indications. The agency acknowledged that the indications are presented at the end of the video and as part of the risk presentation. However, the reviewers concluded that the information failed to mitigate the misleading impression created at the start of the videos.
That conclusion partly reflects the use of a “small, plain font” to present the information for about five seconds during the risk presentation. With the risk presentation competing for healthcare professionals’ attention, the FDA ruled that it is difficult for viewers to adequately process and comprehend the text.
The untitled letter indicates healthcare professionals were the target audience for videos, but otherwise contains little information on the intent of the content. The FDA referred to the materials as “Esophageal Cancer_MOA Video” and “NSCLC_MOA Video.” In medicine, “MOA” is an abbreviation of “mechanism of action,” a term describing how a drug acts on the body.
The Photofrin website features a page titled “3D Mechanism of Action” that only lists safety information. An archived version of the website shows the page featured the subheadings “Esophageal Cancer” and “Non-Small-Cell Lung Cancer (NSCLC)” as of mid-February. The subheadings are followed by white space with similar dimensions to a landscape-orientated video.