FDA Slams Phoenix Molecular for Promoting Investigational Drug

CDER Office of Prescription Drug Promotion (OPDP) has cited Phoenix Molecular Imaging Center for promoting an investigational drug, 11C-acetate, as safe and effective on a Web page touting prostate cancer imaging. “Your Web page describes 11C-Acetate as a useful PET scan agent for detecting recurrent prostate cancer,” a just-posted 2/15 OPDP untitled letter says. “This use is one for which a prescription would be needed because it requires the supervision of a physician and, thus, adequate directions for lay use cannot be written.”

The letter says that while there is one sentence on the Web page stating that 11C-acetate “is available under expanded access clinical trials at multiple institutions,” this does not convey that the product is investigational, “in light of the repeated suggestions the drug is interchangeable with, or even superior to the approved product 11C-choline.”