The creative agencies that produce marketing materials for pharmaceutical companies must stick to the truth, the whole truth, and nothing but the truth. “We can never say things like ‘it’s the best’ — things you see all the time in consumer advertising,” says Gregory Gross, copy supervisor at DDB Rx, a New York advertising firm that serves the healthcare industry. “Our claims must be supported by hard data.”

To ensure that everything said is a “defensible true claim,” the marketing process for the pharmaceutical industry is elongated, requiring that materials jump through several hoops before entering the marketplace. This means precision during the creative process, with artists and writers sticking to the facts, as well as submitting to multiple reviews — informal and formal.

Gross speaks on “Pharm Fresh: Producing Great Creative in a Regulated Industry” at the third annual Thinking Creatively conference, a two-day event beginning on Friday, March 24, at 9:30 a.m. at the University Center of Kean University. The conference is co-sponsored by Kean University’s Office of University Relations and Design Center and by the Art Directors’ Club of New Jersey. Cost: $150. For full details visit www.adcnj.org.

The tight control of pharmaceutical marketing materials is part of the general regulation of the pharmaceutical industry. Although regulation contributes to the cost of medications and lengthens the time to market, most consumers wouldn’t have it any other way. Yet for most of modern history, the public did not have an agency and laws to protect it from tainted food, destructive drugs, and poorly designed medical devices. Regulation of drugs and drug marketing came only in the wake of three medical catastrophes.

First, in the 19th century, companies were marketing morphine as a “soothing syrup” for teething babies and for people with persistent coughs and other ailments. The result was widespread addiction to cocaine and morphine. Not until the beginning of the 20th century was there a wave of reform efforts to control these “secret-recipe” patent medicines — medicines that could be extraordinarily dangerous. The American Medical Association led the forces of reform, pressuring drug makers to abide by the AMA’s “rules for ethical medicines” in drug marketing. Eventually the Pure Food and Drug Act of 1906 codified some of these regulations.

A second disaster occurred in 1937 when sulfanilamide, a drug whose powder and tablet formulations had been successfully used to treat streptococcal infections, came out in elixir form. An untested ingredient in the solution was diethylene glycol, a chemical normally used as antifreeze. This deadly poison killed over 100 people in 15 states, most of whom were children, and the chemist who formulated it committed suicide. The consequence of this second tragedy was the passage of the 1938 Food, Drug, and Cosmetic Act, which gave the Food and Drug Administration authority over product safety.

The most recent tragedy, at its worst in the late 1950s and early 1960s, struck children whose mothers had taken thalidomide during pregnancy to relieve morning sickness and to induce sleep. A number of these women gave birth to children with birth defects, including malformed or missing limbs as well as internal deformities that led to early deaths. Gross says that the crisis was worst in Germany, where the drug was invented, and where there were about 10,000 victims, only half of whom survived.

At about the same time, says Gross, growing public concern with drug companies as “profiteers” had led to an effort to tighten restrictions. But as Senator Estes Kefauver of Tennessee pressed for reform in the late 1950s, his efforts were considered “antibusiness,” and he got little support. “But as soon as thalidomide hit, the opposition evaporated,” says Gross, and the Kefauver-Harrison amendment of 1964 was supported by President Kennedy and passed unanimously by both houses of Congress. This established FDA control over pharmaceutical advertising and gave the FDA the responsibility to judge the truthfulness and scientific accuracy of all promotional drug messages.

Gross, previously an English professor at Roosevelt University in Chicago, had started to think about changing careers because of the improbability of finding a tenure-track position in a city where he might want to live.

He managed to parlay a summer job experience in advertising and his expertise in writing and language — he knows Latin, French, and German — into an entry-level job with an advertising agency in Chicago, where he grew up. He worked there on employee recruitment campaigns for corporations. “It was a remarkably good fit,” he says. “A lot of the skills I developed in academia transferred nicely into my work in advertising.”

Finding himself unemployed after massive layoffs in Chicago’s advertising sector during the 2001 recession, he spent the summer looking for work. Then came 9/11 and things got worse. “I was on the cusp of getting hired,” he says. “Then there was a new hiring freeze because of the uncertainty, and it seemed that pharmaceuticals was the one area in advertising still growing and unaffected by the recession.”

Following a lead in New York, he got a job with Cline, Davis, and Mann in November, 2001. Just a year ago DDB Rx was spun off from Cline “to better serve the needs of a growing client.” Both companies are held by Omnicom.

At Cline and DDB Rx Gross has done pharmaceutical marketing and advertising, which is similar to standard product marketing, but which differs in the review process. “What you learn when you join this industry is that you have to have a long development timeline, with a round of internal and external reviews,” he says.

Gross describes the extended process that his materials — including direct-to-professional materials, ads in journals, and a battery of sales materials — undergo from creation through review:

Concepting the campaign. “The creative side is not much different from the rest of the advertising world,” says Gross. They look at product features and benefits, consider the audience, and do the same kind of conceptual brainstorming, “but with the caveat that it has to be a defendable true claim.” For Femara, a breast cancer drug, his team developed a campaign that “married” hope from the patient’s perspective and good science from the doctor’s perspective.

One central image is a woman wearing a “ribbon” — with the shape of the familiar pink ribbon for breast cancer, but with writing on it from a landmark cancer study in a prestigious medical journal. “For doctors, what’s motivating is the data,” he says. “What we think of in our neck of the woods as a sexy message includes a percentage and a study end point.”

Creating the ad. The ad is the centerpiece from which all of the marketing pieces are derived. These materials must legally have what is termed “fair balance.” Gross explains: “Whenever you make a claim about what the drug does, you have to balance it with statements about what it doesn’t do, so well or any adverse side effects. The materials must include all pertinent safety information.”’

Creating corollary materials. Concurrently with the ad, the creative team must develop the primary sales tool that sales reps will take into a doctor’s office — an 8-to-10-page booklet that tells the complete story of the drug, including the clinical trial design and all the data about efficacy, safety, and tolerability. “These are all designed to work as a set,” says Gross. “We want them all to be consistent for maximum recognition.”

Testing the materials with doctors. During market testing of the materials, the creative teams goes through several iterations of graphics and copy until they develop the most compelling message possible. A key test is how doctors react.

Running it by the client. Pharmaceutical companies have their own review committees, consisting of a lawyer, a medical expert, and a regulatory expert. Each must review and revise every piece of marketing for legality, medical accuracy, and regulatory adherence.

Submitting ads to the FDA. During this last step, the FDA “goes through the materials with a fine-tooth comb,” says Gross, and sends out a formal letter with mandates for revision if necessary.

Despite Gross’s long detour into academe, he suggests that pharmaceutical marketing may have always been his destiny.

“For a while I thought I wanted to go to art school,” he says, “then I decided I wanted a classic liberal arts education.” He says he didn’t have sufficient confidence in his artistic talents, even though he “loved doing art.” He ended up studying English, “because it was less intimidating.” He earned a bachelor’s degree in English from Tulane University in 1986 and a Ph.D. in English from Brown University, with a dissertation on 14th-century literature.

But when he was a kid and people asked him what he wanted to be, Gross says his answer was “either a poet or an artist or a chemist.” Perhaps, then, being a copywriter in healthcare marketing combines these two aspects of his childhood aspirations. As Gross concludes, “So maybe it does make sense that I am doing pharmaceutical advertising.”

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