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Merck & co.'s October 1981 ad launch for Pneumovax, at the time a new pneumonia vaccine, may not have been beautiful creative, but it is credited with launching today's nearly $1 billion direct-to-consumer advertising business.

While other pharmaceutical marketers later spent more money for campaigns that ran longer, Merck's copy-intensive b&w ad in Reader's Digest appears to be the first.

The effort was remarkable at the time, given a lack of Food & Drug Administration guidelines for marketing prescription drugs to consumers. Until then, pharmaceutical companies only reached out to doctors through medical journals.


The FDA remained dubious of DTC pharmaceutical advertising and tried to shoehorn its original 1969 rules for medical journal advertising onto TV and print ads for nearly 28 years, as it debated what to do.

The crafters of those first rules didn't envision consumer advertising, and the guidelines were difficult at best and impractical at worst to apply in consumer media.

As a result, the three-month campaign for Pneumovax was not followed by a flood of similar advertising.

Prescription drug marketers and FDA have traveled a long and twisted road to arrive to a time when it is sanctioned to use TV commercials to advertise both the brands and ailments they treat to consumers.


Not all of the resistance came from FDA.

"There was an enormous fear of advertising by the drug company people," remembers Steve Barrett, now senior VP at Lowe McAdams Healthcare, New York, and one of the early agency activists pushing DTC advertising.

"You are talking about pharmaceutical company people who grew up in medical research," he says. "In consumer marketing, there is an inherent faith in the value of spending aggressively on brand building. But the pharmaceutical industry, which never questioned spending millions on doctors' samples, saw advertising as a `cost' and wanted immediate return on investment."

Those early days are replete with examples of agencies being hired and then fired -- without any ads ever running -- as pharmaceutical companies experimented with the idea of consumer advertising.


Further, Washington Legal Foundation says drug companies desperate to get their drugs through an already slow FDA approval process feared challenging the agency on its advertising policy or the perceived conflict of the FDA's powers in both areas.

In February 1983, when then-FDA Commissioner Arthur Hull Hayes ordered a moratorium on DTC advertising so the government agency could review its rules, there weren't many DTC ads but there were some exceptions.

In May, Boots Pharmaceuticals ran a six-week test of TV advertising in Tampa, Fla. The ads compared the cost of Boots' Rufen ibuprofen (then a prescription drug) with Upjohn Co.'s Motrin.

The ads boosted Rufen's share, but FDA ordered Boots to remove any mention of the drug's use to treat a disease.


The federal agency still had not created any new rules by September 1985. Under some congressional pressure, however, FDA noted it was lifting the moratorium in part because few drug companies indicated an intention to enter DTC advertising.

A few months later, CBS was eager to take advantage of the new potential. It issued its own broadcast ad guidelines to avoid commercials that "tend to frighten or are overly emotional."

It was four more years before a broadcast ad was aired.

Meanwhile, prescription drug marketers didn't hesitate to experiment with print advertising. Print ads, according to FDA guidelines, could mention a product's brand name and the disease it treats as long as they included side effects warnings and dosage information, just like in medical journals. That meant a page of image advertising had to be accompanied by a page or more of disclosures.

Merrell Dow broke unbranded print efforts in October 1985 for Seldane and Nicorette. The effort, with an initially small schedule, was created by Medicus Intercon, New York.


Unbranded ads -- those that did not mention the drug's name -- were clearly an easy way to avoid trouble with the FDA.

But in September 1987, Sandoz Corp.'s pharmaceutical division ran newspaper ads for Tavist-1 antihistamine from Romann & Tannenholz, New York that included the brand's name -- while it was still a prescription product.

FDA required Sandoz to change the ad, which claimed that the brand was better than others on the market, because it contained "outdated" information, as other brands had since come out.


Finally, in December 1987, Merrell Dow broke the TV barrier when it pumped $3 million into TV spending for Nicorette, a nicotine replacement gum.

Broadcast advertising was more difficult to develop than print.

To avoid disclosure requirements -- entailing three minutes or so of scrolling type -- drug makers had a choice. They could either present information about a disease without ever mentioning the drug's name (so called "condition" ads) or they could advertise a drug brand alone ("reminder" advertising). The FDA didn't allow running both kinds of broadcast advertisements at the same time.

Unbranded ads could include a pharmaceutical company's name and a toll-free direct response telephone number.

The Nicorette TV campaign was created by Medicus Consumer Communications, New York, and later switched to Gross Townsend Frank Hoffman, New York. The commercial urged smokers to keep their pledges to stop smoking and to see their doctors for a program to fight nicotine addiction.

In early 1988, TV commercials from Medicus for Seldane featured a nurse suggesting there was finally a product to provide relief for hay fever. The commercials didn't mention the product's name, but print ads at the time featured the same nurse and the product's name.


Although Seldane and Nicorette were on TV first, Upjohn was the first heavyweight spender. It's decision to support Rogaine, a potential answer to male baldness, with up to $35 million in 1993 set an example for DTC advertising to follow.

Frank Hone, exec VP at DTC agency Rubin Ehrenthal & Associates, New York, says Upjohn's heavy consumer spending on Rogaine certainly made more drug companies examine consumer advertising.

But Rogaine's situation was widely viewed as unique. There was little risk of incurring doctors' wrath in advertising Rogaine, because doctors weren't previously consulted about hair loss.

"The problem we had was that hair loss was not perceived as a medical condition. It wasn't something men thought of going to a doctor to see about," says Bruce Houtman, then a DTC pharmaceutical communications specialist at Upjohn and now manager of DTC communications for urology products at Pharmacia & Upjohn.

Consumer advertising was clearly needed to explain Rogaine.

Upjohn's TV advertising for Rogaine from Saatchi & Saatchi's Klemtner Advertising, New York, broke in November 1988. It featured a man sitting by the beach and suggesting that maybe hair loss wasn't as inevitable as the tides.

"We negotiated with the FDA and they had to think long and hard about it," says Mr. Houtman. Rogaine's well-known infomercials came later, in 1994.

"Rogaine was an anomaly," says Mr. Hone.


Still, TV advertising continued to grow slowly.

In 1992, Marion Merrell Dow's agency Fort Lee, N.J.-based Lewis & Gace, recommended running a 15-second commercial on the Super Bowl to improve name recognition for Nicoderm, the nicotine patch system.

"Our research showed that when people came in and asked for a patch, doctors would generally give them the patch they specified," says Mr. Barrett. "So our thought was this was an awareness game."

Rival drug Habitrol from Novartis, was receiving more support, with $10.5 million on TV, but it was Nicoderm's ad -- showing two men at an airport and naming the drug without saying what it was for -- that ran on the Super Bowl. The wall had been broken.

Finally, in August 1997, the new FDA TV rules came down, already prompting a major increase in spending for new products whose names are not yet household words. FDA also began allowing print advertising disclosures to be written in consumer-friendly language early last year.


FDA maintains a close watch so that DTC advertisers don't stray too far from its guidelines. Schering-Plough Corp.'s Claritin received a warning letter for its new TV ad in August, days after the rule relaxation. And Searle Co. ran into trouble for a Spanish-language ad in Puerto Rico for Covera-HS that lacked risk information, balance or "adequate provision" for those things.

John Kamp, American Association of Advertising Agencies senior VP, predicts marketers whose products are already known may decide to continue to use the old rules.

"The new rules require long spots and confusing messages," he says. "In some ways, the old rules are a simpler straightforward ad. But for new drugs where the name is not known, TV will become the way to get the name across."

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