Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The FDA has judged that an advert made by MGI Pharma to promote its brain cancer product Gliadel Wafer is misleading, according to a letter released by the health authority.
Subscribe to our email newsletter
Gliadel Wafer contains the cancer chemotherapeutic drug carmustine and is implanted directly into the tumor as an adjunct to surgery and radiation.
The FDA said that the two-page promotional piece is misleading because it fails to disclose the full indication and presents unsubstantiated claims regarding the product.
The FDA said that the advert states “take the path to avoid treatment delays,” and “Gliadel works at day one,” suggesting that early use of Gliadel Wafers provides clinical benefit during the 14 days from implantation to the start of radiation therapy, and represents the basis for effectiveness. The US regulator said that it was not aware of any evidence that the efficacy of Gliadel Wafer results from the ability to use the product at the time of surgery.
MGI Pharma was also criticised for failing to disclose that the product was approved for use in addition to surgery and radiation.
The agency requested that MGI Pharma immediately stop using the ad or any others that are similar. It also requested a written response from the company by February 9, 2007.