IND Promotion Quandary Again Trips Up Burzynski Research Institute

07 Nov 2012

• By Martin Berman-Gorvine

The institute has come under scrutiny in the past for how it describes its investigational cancer products, but more mainstream oncology companies have also been cited for jumping the gun with promotional claims for products FDA hasn’t yet approved.

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...