Making the switch

For pharma companies looking to launch an over-the-counter version of a prescription drug, education needs to be a crucial component of communications efforts.

For pharma companies looking to launch an over-the-counter version of a prescription drug, education needs to be a crucial component of communications efforts.

When GlaxoSmithKline (GSK) prepared to launch its over-the-counter (OTC) version of its highly successful weight-loss drug orlistat earlier this year, the company's first step was to emphasize education in its communications efforts to ensure the new product, to be called Alli, was understood by consumers.

That effort began well before Food and Drug Administration approval for OTC use. Web site www.questioneverything.com was launched without mentioning the Alli brand (per FDA requirements) and attempted to address the weight-loss issue honestly. Included on the site was a "readiness quiz" to determine whether the interested party was a candidate for the drug, as well as recipes to help consumers diet healthfully.

That site eventually transitioned into http://www.myalli.com/ after FDA approval. A message board on the site allows consumers to discuss how the Alli diet works and pose physical activity questions to the company's fitness specialist.

Steve Burton, VP of weight control for GSK consumer healthcare, and the marketing team wanted a space separate from the main site where they could interact with consumers more broadly on the issue of weight loss and discuss important points amongst themselves. So they created the blog http://www.alliconnect.com/.

"It was a part of our overall communications plan," Burton says of the blog. "We just felt we wanted a place for myself and the rest of the team to talk to consumers directly about some of the largest issues in the weight-loss category."

Beyond one site

But the effort went further than the Web site to encourage word of mouth on the benefits of the new product. GSK created a book called Are You Losing It? Losing weight without losing your mind. Instead of being sold in bookstores, the 100-page book intended to greet consumers where they were looking for solutions to their weight problems - in the aisles where they eventually would find Alli, says Brian Jones, VP of communications for GSK consumer healthcare. In addition to recipes, the book discussed exercise, with limited space devoted to the drug itself.

In New York's Union Square, the communications team, which included HealthSTAR PR, turned a former bank into a prelaunch pop-up retail site. The space was an exhibit showing the confusion over dietary supplements and the opportunity Alli presented. The team ran several of its prelaunch media conferences from the location, as well, and hosted demonstrations from a chef who created low-fat variations of popular recipes.

Initially, the drug was chosen by GSK as a good candidate for the Rx-to-OTC switch for a number of reasons. First, there was little question about its safety. Unlike fen-phen, the anti-obesity drug from Wyeth that was pulled from the market in 1997, Alli didn't affect the heart. The drug works non-systemically, inhibiting an enzyme that breaks down triglycerides in the intestine.

But there was a second, equally important, reason the drug was chosen as an ideal candidate to go OTC - the timing couldn't have been better. "Over the past seven years, obesity has gone from a minor issue to one where you can't pick up a paper and not read about it," says Jones.

Obesity as a public health concern has indeed surged in recent years. According to research published in the Journal of the American Medical Association, obesity in adults doubled from 1980 to 2002. American taxpayers were paying the price, too. In 1998, costs related to overweight or obesity issues reached $78.5 billion, according to the Centers for Disease Control and Prevention. Approximately half of those costs were paid by Medicaid and Medicare.

In 2004, in an attempt to address the growing attention surrounding the problem, President Bush charged then-Health and Human Services Secretary Tommy Thompson with finding a solution. In March of that year, Thompson launched the Healthy Lifestyles and Disease Prevention campaign, which sought to address the country's expanding waistline through a multimedia education campaign.

With the interest in obesity as a public health concern surging, key opinion leaders began to look for a way to steer consumers away from the misinformation of the supplement aisles. GSK's campaign came at just the right moment to address those concerns, especially for doctors, who have long resisted going beyond the "be active, improve your diet" talk in dealing with the issue.

"The communications challenges we had were directly related to the status of dietary supplements," Burton says. "A lot of people believe those supplements had been approved by the FDA."

Supplemental education

And so, with a safe drug, a marketplace clamoring for such a product, and key opinion leaders looking for any option that wasn't a supplement, GSK saw its opportunity. Those involved in the communications efforts for the OTC switch say that's why the focus was put on education - specifically dispelling myths surrounding supplements and weight loss.

"There was really a natural need in the market that was recognized by all the stakeholders, which was when you go into the drug store and walk down that aisle in the drug store, it has supplements with no clinical data behind them," notes Erinn White, EVP and GM of HealthSTAR PR. "When you talk to key opinion leaders in the obesity space, you can see them get physically angry and agitated about it."

"It was a good example of a market that had not really existed in a medical mindset before," adds Helene Ellison, president and CEO of HealthSTAR.

GSK had experience in the motivational therapy arena. Many working on orlistat/Alli had been heavily involved with GSK's smoking-cessation products, and the education efforts surrounding Nicorette gum and Nicoderm CQ informed some of the strategy that would shape the backbone of the Alli launch.

"It was that experience in nicotine-replacement therapy that I think, eventually, when we were looking around for the next major opportunity to bring another brand or product over the counter, we naturally looked to weight control," says Burton. "Our communication has not been focused on driving sales as much as helping to educate people."

HealthSTAR won the business for Alli in September 2004, but Ellison's history with the compound goes back a few years. While still at Straus Communications, she worked on the product when it was still in Phase III and was marketed by Roche Pharmaceuticals as Xenical. Upon winning the business this time around, the agency set out to evaluate the market, aiming to tap into a multi-disciplinary group.

It conducted an in-depth survey, covering 3,500 people who completed 25-minute phone interviews about their weight-loss efforts. Armed with evidence that people could benefit from an OTC product that was both safe and effective, the team set out to speak to professional groups, patient groups, policy experts, and employers. GSK also formed an association with the American Pharmacists Association, providing the group with education toolkits on weight loss to supply their members with.

Ellison and White felt confident that GSK understood the need to be up-front with consumers, especially when it came to a market with so much misinformation out there. "Glaxo, to its credit, really understood that because of the history of the product, it really had to let people understand how it was going to approach it differently, with honesty and with the fact that there needed to be a change in consumer behavior for this to be successful," White says.

On January 23, 2006, an FDA advisory panel voted to recommend the OTC switch, with final approval granted in February 2007. It was the first weight-loss drug approved by the FDA to be sold OTC.

As with many OTC switches, the success in Alli was sown before it ever hit the market. With the communications team focusing on education efforts and media outreach, the drug was widely discussed in the media, even before final approval. The tidal wave of coverage helped spread the word that there were currently no regulated weight-loss drugs and that Alli sought to fill that void.

"By the time a drug gets to an OTC switch situation, you're fairly comfortable about its safety and side-effect profile," says Debra Gaynor, chief creative officer and MD of healthcare for Burson-Marsteller, who has worked on OTC switches in the past. She says the difference between working for OTC and prescription approval is simple: A lot more information is available when a drug has already been on the market for a significant amount of time.

A switch in focus

And for that reason, education tends to outweigh other aspects of the communication efforts. One of the most high-profile OTC switches in recent years was that of Barr Pharmaceuticals' Plan B. Despite some substantial political issues, Plan B was another drug whose switch made sense, Gaynor says. With no safety issues and a significant void in the marketplace, the company felt FDA approval was within reach and that education efforts would spur sales.

Carol Cox, VP for IR and corporate communications at Barr, says the challenge was to reach women and help them understand how to get the emergency contraceptive and how to effectively use it.

If taken within 72 hours of unprotected intercourse, Plan B has been shown to reduce the risk of pregnancy by 89%. But it is more effective if taken in the first 24 hours after intercourse, and OTC availability helps reduce the potential time lag that resulted from the need to obtain a prescription.

"We have been consistent in emphasizing this," Cox notes. "As a result of the FDA's decision to make Plan B available OTC to consumers 18 and older, we needed to explain that the product was available as both a prescription and OTC product."

She adds that given its message points, the company engaged in extensive education efforts to physicians, pharmacists, and healthcare providers, along with reaching out to consumers to ensure they understood the product and its availability.

As part of the OTC approval, the company reached an agreement with the FDA on its CARE (Convenient Access, Responsible Education) program that was intended to support efforts to ensure the product was used responsibly and appropriately. Cox says the program was designed to limit the availability of Plan B only to pharmacies and clinics with professional healthcare supervision, as well as to educate healthcare professionals and consumers.

"We've done a number of continuing education programs to pharmacists and pharmacist assistants who would then be able to answer the frequently asked questions a woman might have," Cox says. The team not only addressed consumers via the Plan B Web site, but also sent one-page information sheets to pharmacists nationwide.

There was one hurdle for communications surrounding Plan B that other OTC switches do not face. Despite its approval for OTC use, the drug is sold behind the counter, and the company found that some women were intimidated to request the product.

"We have addressed this issue in a unique way, creating a patient request card that allows women to ask for it discreetly," Cox explains. "Patients just hand the card to pharmacists to purchase the product without having to ask for it out loud." The card debuted in the September issue of Glamour and will also be available on the Plan B Web site in the fall.

Cox says the company's efforts to reach out to both consumers and pharmacists continue, a year after FDA OTC approval. General media interest in the product continues, but Barr hopes to communicate additionally through its Web site, professional materials it continues to develop, and other marketing initiatives, Cox says.

A more general challenge

The Rx to OTC switch presents an interesting challenge to communicators: Can the company conduct a dialogue with the general public and, in the end, educate them on the benefits of both the product and the void that product is filling?

In one sense it's awfully similar to efforts made for products awaiting FDA approval for prescription use. But there are crucial differences. As Gaynor points out, much more is known about the product. So instead of convincing the FDA that safety issues are essentially non-existent, the challenge often becomes dealing with the general public and pharmacists instead of a niche group that would take a prescription drug.

With both Alli and Plan B, the companies behind the products were under pressure to provide accurate messages to consumers in areas that were muddied with misinformation. In both instances, the communicators addressed the larger need for the product and engaged consumers with education efforts aimed at a greater understanding of the product.

And, ultimately, it's that education that can make a launch successful.

"I think one of the significant achievements of this launch - and owing in large part to the assistance we received from HealthSTAR and our other agency partners, as well as the intense interest of the media and the public health community in having a safe and effective option available to consumers - is that even before we had FDA approval, there was a lot of attention and interest focused on this opportunity," GSK's Burton says.

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