Arthritis medicine Rufen pushed the envelope on DTC advertising in 1983. The FDA quickly imposed a two-year moratorium on using brand names in DTC ads. Illustration courtesy of MediciGlobal. 

Liz Moench was there at the very beginning. At 23, she joined Boots, a Louisiana-based upstart known to few people outside the pharma universe. She knew relatively little about the industry herself. During her job interview with John Bryer, then Boots’ president, she innocently asked why patients weren’t viewed as the company’s target customers.

That wasn’t the type of question that pharma marketing execs were asking back then, though, in retrospect, it’s the type of question that should’ve been asked far sooner. “It was radical to come in from the outside,” Moench says, referring to her previous gig in TV advertising. “And it was radical to have a senior executive who was really open-minded in his thinking. [Bryer] was a real maverick.”

See also: DTC: The first 10 years

Within months, Moench had played a leading role in creating the healthcare industry’s first DTC TV ad. Here’s her story, as well as those of two other DTC titans, Francis Gace and Steve Andrzejewski.

1983: THE FIRST DTC SPOT

On May 13, 1983, the first broadcast television commercial in the United States for a prescription drug aired for anti-inflammatory drug Rufen featuring then Boots president John Bryer.

Moench’s ad, for Rufen, an anti-inflammatory drug, aired in Tampa on May 19, 1983. It targeted an audience that was a “good representation of the demographics of the U.S. at the time,” Moench recalls: existing patients who already knew about ibuprofen. The spot made no representations that it was intended for treating arthritis.

Per the advice of the Boots legal team, the ad focused on pricing, with Bryer himself noting that Rufen was 20% cheaper than competitor Motrin. “We didn’t say what [Rufen] was for. We didn’t talk about it being better than another drug, or any of its benefits,” Moench continues. “By running a price ad, we didn’t need to go into the issue of the package insert.”

See also: How the FDA Advanced DTC Advertising

Boots timed the Rufen ad to coincide with a front-page marketing feature that ran every Thursday in The Wall Street Journal. The drugmaker gave the newspaper an exclusive interview about the ad, for reasons that transcended marketing.

“That was our way of notifying the FDA,” Moench reveals. “We didn’t tell them the date we were launching. We’d had our meetings with them, but they wouldn’t tell us if they would take action or not. And the law had no specific regulations governing consumer or DTC ­advertising, which is why we ran a newspaper [ad] with the full package insert.”

Within two days of the ad’s airing, the FDA sent Boots a cease and desist letter. It also imposed a two-year moratorium on DTC advertising using brand names. But the cat was out of the bag.

See also: Celebrity pharma ads: Opportunity or PR disaster?

Four years later, as the executive director of public affairs at Ciba-Geigy (today part of Novartis), Moench helped recruit what is thought to be the first celebrity spokesperson for a prescription drug: legendary New York Yankee Mickey Mantle, who spoke on behalf of prescription pain relief drug Voltaren.

“We had to meet Rep. John Dingell, who was part of the oversight committee looking at marketing practices in the pharmaceutical industry, because Mickey got onto Today,” Moench recalls. “When Mickey thought the interview was over, he said, ‘You know, this drug works great for hangovers.’ So millions of people heard this. I’m sitting in the holding room going, ‘My career’s over.’”

1992: THE SUPER BOWL

Marion Merrell Dow’s Super Bowl ad for smoking-cessation patch Nicoderm cost about $1 million for 30 seconds of airtime.

In the wake of the FDA’s two-year moratorium on branded DTC advertising, the industry was skittish. Bold moves were few and far between — until Marion Merrell Dow launched the industry’s first Super Bowl ad, in January 1992, featuring smoking-cessation patch Nicoderm.

“We knew in the Super Bowl audience, which was going to be anywhere between 80 and 100 million eyeballs, there would be a fair number of smokers,” recalls Francis Gace, cofounder of Lewis & Gace, the agency that worked on the ad. “Plus any ad on the Super Bowl got talked about. We could anticipate a fair amount of word of mouth, particularly if we were the first on the market.”

See also: DTC Report 2016: Gut Check

To skirt the requirement of a time-consuming full disclosure, which included warnings, side effects, and benefits, the drugmaker could only name the product and say what it was, not show the patch itself. The spot featured two men taking an escalator at an airport. One man said, “Nicoderm.” The other responded, “Yes, it’s a patch.”

“That’s about all we could say in the entire commercial,” Gace adds. “But we figured that we’d already marketed Nicorette. The name similarity was close enough. We figured it would be clear to anyone who was watching that we were talking about smoking cessation.”

The ad cost about $1 million for 30 seconds of airtime. Habitrol may have outspent Nicoderm in detailing ($34 million to $19 million), sampling ($9.6 million to $4.5 million), and consumer advertising ($34 million to $23 million), yet Nicoderm became the number one prescription brand among smoking-cessation patches.

Schering-Plough broke DTC ground in 1997 with “Ask your doctor about Claritin.” The line still resonates. Photo courtesy of Ogilvy CommonHealth Worldwide. 

1997: DTC BUDGETS SKYROCKET

In 1997, the FDA issued draft guidance allowing pharma companies to advertise on TV without the brief summary that took up so much print space as long as they directed viewers to a magazine ad, a toll-free phone number, or a website for such information.

Schering-Plough, which manufactured allergy treatment Claritin, jumped on the opportunity (Schering was acquired by Merck in 2009).

With its renowned Blue Skies campaign, created by CommonHealth’s Thomas Ferguson Advertising, the marketing team upgraded from unbranded reminder ads to branded spots. Blue Skies evolved into a multichannel campaign that included radio, print, and TV ads, all advising consumers to “ask your doctor about Claritin.”

“A lot of people were ask­ing, ‘Is this something you should do or not?’” says Steve Andrzejewski, who worked on that launch as VP of marketing for S-P. “‘Ask your doctor about Claritin,’ without claims, raised awareness of the name Claritin and the number one question from people seeing the ad was, ‘What is Claritin?’ It ended up educating customers that there are alternatives that wouldn’t make them sleepy.”

2016: THE EVOLUTION OF DTC 

Looking back at the ­evolution of DTC advertising, Moench, now president and CEO of MediciGlobal, reckons that the groundwork for change was laid in the 1980s. “Back in the ’70s, patients did what doctors told them,” Moench quips. “In the 1980s, environmentalists fueled change.”

To help low-income and minority communities situated near factories and landfills, the environmentalist movement pushed for the Emergency Planning and Right to Know Act of 1986, designed to hold corporations accountable for the release of toxic chemicals in populated areas. During the same period, AIDS activists sought to involve patients in the regulatory process, HMOs emerged to allow consumers to choose their health plans, and the notion of a patient’s right to understand gave birth to patient package inserts (PPIs), Moench explains.

See also: 4A’s announces plans to defend DTC

“So you had these four movements — AIDS, DTC, HMOs with choice, and PPIs with understanding,” says Moench. “And that’s now been picked up in the 2000s by rare-disease groups. We talk about patient-centricity now, but it was happening in the ’80s.

“Today’s ads are lifestyle-based and aspirational,” she continues. “There seem to be a lot of themes about being with family, being able to do things that are active, being able to function at your job.” Celebrity spokespeople continue to be widely used, but Andrzejewski, now an adjunct professor of health economics at NYU’s Stern School of Business, notes a recent rise in the use of animation and caricatures.

All three execs point out, with some degree of amazement, how deeply DTC ads are now woven into the fabric of industry marketing.

“In the days of Rufen and Nicoderm, [ads for] Viagra and similar products were probably far from anyone’s mind,” Gace says.

See also: A ranking of 2015’s DTC Ads

Adds Andrzejewski, “Now there’s a higher comfort level on the pharma company side and there’s a clearer path of what to do with the FDA.”

At the same time, the DTC space has gotten crowded. And much to the consternation of TV advertising loyalists, budgets are now spread across a range of channels.

“In the past, there weren’t as many companies involved, especially in TV advertising,” Andrzejewski notes. “Today, getting the message to the intended audience is much more important because there are so many messages out there.”

2017 AND BEYOND

The value of DTC advertising continues to be a contentious topic. The AMA called for a ban on DTC advertising of drugs and devices in late 2015, linking it to inflated costs. More recently, a New York Times op-ed and a JAMA editorial criticized Bristol-Myers Squibb’s DTC ads for cancer med Opdivo, characterizing them as misleading.

DTC boosters say that the ads, along with social media, have helped patients become better informed while allowing them to play a more active role in their health decision-making. But Moench notes that DTC advertising is not as patient-centric as it should be.

Similarly, Andrzejewski says more effective hypertargeting is critical to keep patients engaged. “Healthcare plans are playing a bigger role, and those systems are going to have something to say, so it’s important for people to be very targeted,” he explains. “Once you have the demographics, it makes the advertising spends that much more efficient because you can target them that much more specifically.”