The big debate about drug promotion may focus on DTC advertising, but a pair of UCLA medical school professors believes product placement should be considered a distinct form of promotion that requires new FDA guidelines.

After all, there may well be more restrictions on DTC after the presidential elections, and consumers are increasingly using TiVo and remote controls to ignore commericals. In general, the UCLA researchers note that the overall market for product placement rose 30.5 percent to $3.5 billion in 2004, according to their paper in The Journal of Public Policy & Marketing. And in 2006, there were 462 mentions of prescription meds on TV shows.

So far, placements haven’t been widely used. Examples include Pfizer’s Zoloft antidepressant showing up in The Sixth Sense and Organon’s NuvaRing contraceptive on Scrubs. Why not more often? The researchers suggest drugmakers are conservative; pharma has concerns about trivializing meds and illness by association with entertainment, and difficulties in translating meds into popular culture.

Nonetheless, they analyzed medical-themed network TV shows in 2005. For the most part, they wrote it was “impossible” to determine whether any med was a deliberate placement, except “one brand seemed unusually suspicious as a commercial drug placement” - TAP Pharmaceuticals’ Lupron, which decreases hormone production.

The drug was mentioned four times in an episode of House, and was used by the show’s docs to treat hypogonadism, which is not an FDA-approved indication. At the same time, they note that a newer version was being tested for hypogonadism for FDA approval. “”The off-label use of this product in this show and the concurrent FDA trial appear more than coincidental,” they wrote.

Spokespeople at TAP and Fox TV were contacted, but declined to comment to the UCLA reearchers. Such episodes prompts them to suggest new guidelines, especially since the FDA doesn’t have a specific policy for overseeing the way drugs are oromoted outside of traditional commercial advertising, such as in placements in fictional shows.

“The concern with placements as a form of drug promotion is that, at its most benign, it may skirt FDA regulations, such as the need for a balanced discussion on effectiveness and risks and, at its worst, may violate FDA marketing policies altogether,” they write.

“Because television shows and cinema are fictional and do not claim to reflect reality, any subtle mention of a medication may be protected from FDA regulations by the First Amendment,” they continue. “Distilling ‘creative license’ with a drug inclusion from promotional placements is difficult for viewers and potentially for regulators as well. Such murkiness makes policy making difficult.

Without new regs, they contend, “product placement may be limited only by the industry’s reticence or consumer backlash if deemed egregious.”