MARION CARDIZEM SR VIDEO NEWS RELEASE SPOTLIGHTED

MARION CARDIZEM SR VIDEO NEWS RELEASE SPOTLIGHTED as an example of disguised consumer promotion in a short segment on a recent CBS "This Morning" program. In an April 17 segment narrated by CBS health commentator Dr. Bob Arnot, a Marion VNR on the recent January approval for the sustained release version of diltiazem was used to portray concerns about the promotional/eductional messages expressed on camera by Health Research Group Director Sidney Wolfe. The consumer advocate declared that "in almost every instance, where we've seen TV advertising or these TV Video News Releases, it's a drug which really doesn't have a distinct advantage over other drugs." FDA Drug Advertising and Labeling Division Director Kenneth Feather told CBS that FDA is aware that the VNRs may be a form of hidden promotion. "We are concerned," Feather said, that viewers of TV news may "not know that these messages are, in fact, promotional messages by the company on behalf of the company." Commenting on a description in the Marion VNR of Cardizem SR as "a new and different drug," Feather said that "it is not necessarily new, nor is it different." Noting that only the dosage form is different, Feather remarked: "It is not a new product, and Cardizem [SR] is not all that different than the other calcium channel blockers." An advertising executive speaking to a recent conference aimed at biotechnology companies commented on the growing use of video materials for drug launches. Lisa Burns advised a Vector Securities seminar earlier this year that "one of things that is very important" in the preparation for the launch of a product is the preparation of "the video, what we call the B-roll." She said "this is something that I would encourage all of you to do, who are in the therapuetic drug area." The science media, Burns pointed out, "loves to be able to get at how a drug works." She said her firm has prepared a 20-minute tape on interferon including interviews with the investigators, coverage of the drug being manufactured and animated mechanism of action. She pointed out that the video materials provide media an alternative to footage of an FDA press conference at launch. Video news releases, however, do not appear to be at the top of FDA's list of offending promotion techniques. Currently, FDA's advertising division is working on a guidance for company-sponsored education programs lacking "fair and balanced" treatment of new therapies. That guidance may be out by June.