Promoting investigational therapies as if they are already approved by FDA may seem like a bright-line violation but even some well-respected companies have crossed it. The latest firm to receive a rebuke on this score from FDA’s Office of Prescription Drug Promotion (OPDP), Burzynski Research Institute, has a more colorful history than most.
In an Oct. 18 “notice of violation” letter, OPDP cites Burzynski for press releases claiming, for example, that in a Phase II trial in inoperable brainstem...