7-Eleven has partnered with “X-Men Origins: Wolverine” for a month-long promotion that will include life-size standees of Wolverine, Sabretooth and Gambit watching over the shops.

Slurpee cups feature the three, especially notable since the beverage makes a brief appearance in the film starring Hugh Jackman. The character Blob is seen with one of the drinks in a size colossally bigger than any human has ever sipped.

Roche Laboratories mapped new territory with the first mall tour for a prescription drug. This could be habit-forming.

Cooking demos and pedometers. That’s the latest prescription for drug marketers, written by Roche Laboratories.

In fact, the Nutley, NJ, pharmaceuticals company is still writing the script began in January when it tested a mall tour for Xenical, a weight-loss drug.

Roche hosted weekend-long events in eight cities, choosing upscale malls to reach women 25 to 54. Themed “X out one-third of the fat,” the tour included cooking demos, fashion shows, and one-on-one consultations with dietitians and doctors.

Roche and its agency, DVCActiveCare, Morristown, NJ, wanted to see how consumers and the FDA would react to “something so overtly promotional as a mall tour,” explains Cheryl Nigro, vp-management supervisor at DVCA. Roche may roll out or extend its test next year.

Drug companies spent nearly $1.5 billion on direct-to-consumer advertising in 1999. Consumer promotion could grow to be a $150 million endeavor by 2003.

It’s a tricky task to promote prescription drugs. Weight loss is an especially tough segment, given past problems with Phen Fen and the resultant FDA scrutiny.

For Xenical – a fat-blocker that works in the intestines, not on the nervous system like other drugs – Roche balanced product education with lifestyle activities.

“We were very careful about balancing the promotion message with the education message,” Nigro says. “We didn’t want to misrepresent this as a miracle cure. People understood right away that this was a prescription, and weight loss also requires diet changes and exercise.”

Chefs gave low-fat cooking demonstrations, and large-sized models gave 15-minute talks on image and weight loss, covering how to dress while gradually slimming down and how to play up best features. Doctors and dietitians lectured on obesity, diabetes, and drugs.

There was more traffic at lifestyle events, Nigro says, but one education station featuring a body-morphing kiosk drew crowds. Visitors posed for digital photos, then watched as the computer showed how they’d look with 10 percent less (or more) body weight.

A tie-in with the American Diabetes Association gave away Xenical-branded pedometers to mall-walkers who participated in an ADA fundraiser.

Consumers also could consult with a doctor to learn how to approach their own physician. Those consultations complied with very strict FDA guidelines prohibiting doctors in those situations from giving direct patient advice. DVCA helped train docs and dietitians on event protocol, while Roche trained them on Xenical itself. Self-serve kiosks let shoppers get information privately. Initial markets included Kansas City, Portland, Milwaukee, St. Louis, Baltimore, and Pittsburgh – cities with a high incidence of obesity and central to Xenical’s introductory ads. Contemporary Marketing, Inc., Totowa, NJ, helped execute the tour.

UNDER FDA SCRUTINY

The FDA doesn’t distinguish between promotion and media advertising, which exploded in 1997 when the FDA clarified its regulations and marketers realized they didn’t have to present all risk information in TV and radio spots. As for a rise in promotion, “we’ve been expecting this, because more people are going to health fairs and other events that are outlets for promotional activity,” says FDA branch chief Nancy Ostrove.

For ads and promos alike, the agency requires marketers to balance information on a drug’s effectiveness and risks. “We have regulatory authority over ads and promotional labeling, which includes brochures, direct marketing, and materials distributed at events,” Ostrove says.

Fourteen reviewers check thousands of marketing pieces each year; fewer than 15 direct-to-consumer pieces prompted a letter to the manufacturer in ’99. “Some manufacturers don’t want a letter. Others consider it a badge of honor,” Ostrove says.

Manufacturers must submit materials when they are distributed, but many ask for FDA advice in advance. “It’s not good for their cause to anger the populace or Congress,” Ostrove says. “A lot of people don’t like direct-to-consumer advertising because they think it increases the cost of healthcare.”

In August 1999, the FDA issued final guidelines for broadcast ads. Like its 1997 draft, the final guidelines require marketers to disclose product information via four venues: a toll-free number; referral to a current print ad or brochures at convenient outlets; referral to a doctor or pharmacist; or a Web site. But the August draft also encourages marketers to “consider the benefits of providing consumers with non-promotional, consumer-friendly product information in addition to the required product labeling,” the FDA says.

The FDA is especially wary of press releases; company-funded journals, reports, and seminars; lecture tours promoting one product or disparaging a competitor; celebrity endorsements; and videos or CD-ROMs disguised as educational information. The concern is that “surreptitious sponsorships of media materials and events” blurs the line between medical research and marketing, according to FDA material.

While reviewing the Xenical campaign, the FDA was so scrupulous it even asked Roche to revise its original tagline, “X out the fat.” Since Xenical blocks one-third of fat from being absorbed, FDA didn’t want consumers thinking it would “X out” all the fat they ate.

“The creative team wasn’t thrilled about adding a fraction to their [tagline], but they had to be flexible,” Nigro says. “It took a lot of discipline on the creative side to stick with the idea and make it work within all the constraints.”

That includes disclosure of side effects (which sound pretty gruesome in Xenical’s case). The whole campaign came together in an impressive six months: Roche hired DVCA in July and hit malls in January.

Roche is happy with most of its measurements – number of participants and observers, number of premiums distributed – and expects to see sales results kick in this month as prescriptions hit the pipeline. “There are a lot of steps people have to take after our event before it shows up in sales,” Nigro says.

In its fiscal 2001 budget request, the FDA asked for $10 million and 77 full-time staffers to fight illegal online sales of prescription drugs. Here’s its plan:

– Reduce the illegal promotion, sales, and distribution of prescription drugs on the Internet.

– Conduct a public education campaign to help consumers shop for pharmaceuticals from ethical online outlets.

– Use the latest hardware and software to identify the pharmaceutical Internet sites which pose the greatest threat, and support a rapid response team to put them out of business.

– Continue working with the U.S. Customs Service, the Drug Enforcement Administration, and the U. S. Postal Service to monitor drug imports coming into the country from all sources.

– “Patients who buy prescription drugs from such Web sites are at an increased risk of side effects from inappropriately prescribed medications, dangerous drug interactions, contaminated drugs, and impure or unknown ingredients in unapproved medicines,” the FDA reports. The agency spent 30,000 staff hours in the first quarter of fiscal 2000 investigating illegal Internet drug outlets.