NEW YORK (AdAge.com) -- David Kessler didn't mince words. "Your companies likely will face lawsuits eventually about the claims they make for their products in television commercials," the former Food and Drug Administration commissioner told a group of pharmaceutical executives. "One day in a courtroom, I assure you, one of you is going to have your DTC ads played."

Prescient speech
It wasn't just hard-hitting; it was prescient: Mr. Kessler's speech came in 1998, a year after the FDA's momentous decision to relax the guidelines regarding direct-to-consumer TV ads from drug companies.

Since that time, DTC drug advertising has emerged from a dawdling $12 million business to a $4.1 billion ad category spanning some 70 advertised drugs. As predicted, it's also become a lightning rod for political and public criticism, subject to charges that it encourages consumers to pressure doctors for drugs they don't need; that it glamorizes drugs that have later been found to have dangerous side effects; and, in the case of erectile-disfunction drugs, that it uses promotes medicinal drugs for recreational uses.

'Got away from us'
"In some ways, DTC got away from us," said Dr. Kessler, now dean of the School of Medicine and vice chancellor of medical affairs at the University of California-San Francisco.

It was in 1996 that the unmistakable sound of Cole Porter came singing through TV sets across the country, ushering in a decade of what has been a watershed for the advertising and pharmaceutical industries.

"Blue skies, shining on me

Nothing but blue skies do I see."

Groundbreaking Claritin spot
The spot, from Schering-Plough for allergy medication Claritin, never mentioned what the product treated, advising viewers instead that "Clear days and nights are here" and to "see your doctor" -- a phrase that would become a veritable tagline for pharmaceutical ads.

While 2006 marks the 10-year anniversary of the Claritin ad, it was actually 24 years ago that the FDA unwittingly opened the door to DTC. Speaking at the American Advertising Federation conference and addressing the Pharmaceutical Advertising Council, then-FDA Commissioner Arthur Hull Hayes Jr. summarized the state of drug advertising, saying it "may be on the brink of the exponential-growth phase of direct-to-consumer promotion of prescription products."

Drug companies jumped on the phrase "exponential growth" and took it to mean the FDA, however tacitly, supported DTC.

'Opening a closed door'
"It was viewed by the industry as FDA opening a closed door," said Kenneth R. Feather, a former associate FDA commissioner.

A year later, in 1983, Boots Pharmaceuticals aired the first direct-to-consumer TV ad when it promoted its prescription ibuprofen medication, Rufen. The company also ran newspaper ads at the same time. That was in May; by September, the FDA asked the industry for a voluntary moratorium on drug advertisements. (Ibuprofen actually went over the counter a year later.)

In 1984, Upjohn sponsored a major conference on DTC advertising in Washington, D.C., where it made no bones about expressing its opposition to the practice. But less than five years later, Upjohn was touting the merits of DTC after its hair-restoration medication, Rogaine, was approved by the FDA and needed to be marketed.

Things were relatively quiet until 1996, when the Claritin ad appeared and all but forced the FDA to make a decision. Before that, the FDA's guidelines for consumer advertising of prescription medications were the same as its guidelines for professional advertising, which called for full disclosure of risk and benefit information-easy to put in small type in a newspaper or magazine ad, but time-consuming to convey in a TV spot. That's why, when Schering-Plough aired the Claritin ad, it did not say what the product was for.

Landmark FDA decision
The FDA issued its landmark decision in 1997, relaxing the earlier guidelines for TV commercials. Instead of including the "brief summary" that took up a full page in magazine ads and would take too long to explain in a TV spot, pharmaceutical companies could direct viewers to a magazine ad, an 800 number or a website.

DTC exploded almost immediately. Spending shot from $12 million in 1989 to $1.17 billion in 1998.

But the explosion, in retrospect, came too quickly. "I was at JWT in 1997 doing global business development, and all of a sudden we had pharma companies calling on us, including this company called Parke-Davis and something called Lipitor," recalled Brian Heffernan, now the chief marketing officer for GWS, a health-care-ad agency in Columbus, Ohio. "We had no capability or knowledge at the time of what was happening."

Mr. Heffernan said the large consumer agencies, though eager to be involved in the burgeoning new industry, were not as developed as shops that already specialized in marketing to physicians.

Ad industry ill-prepared
"It was new, and the agencies and the ad community in general were ill-prepared," he said. "I was not prepared. It was not part of our space. So we didn't really know what to expect. It was a learning curve for many marketers. You just apply the consumer model, and you take it out as far as you can."

Thus were born creepy animated characters representing toenail fungus, Abraham Lincoln look-alikes sharing seesaws with beavers, and talking stomachs. For many, that model went too far. By the 2004 Super Bowl, when two of the three erectile-dysfunction drugs were advertised during the big game, the public had seen enough. Later that year, Merck's Vioxx-which was heavily advertised, with figure-skating queen Dorothy Hamill featured in the first ads in 1999-was pulled from the market after a clinical trial showed the drug increased the risk of heart attacks in some patients.

Some said the ads had become too heavy on imagery and didn't properly convey the risks and benefits. In contrast, internal ad-agency criticism suggests pharma ads have become formulaic and "dumbed down" because of political pressure and a new code of conduct issued last year by the Pharmaceutical Research and Manufacturers of America.

The PhRMA guidelines include a 15-point code of conduct. While falling short of a mandate on the most serious issues-it did not call for a one- or two-year moratorium on ads following FDA approval of a new product, for instance-the PhRMA code did restrict ED advertising to between 10 p.m. and 6 a.m. and banned all 15-second "reminder ads."

'Impacting behavior'
The "dumbed down" charge is "a miscast argument," said John Weyrauch, team leader-consumer strategy and planning for Pfizer's U.S. pharmaceuticals business. "There's new work in the sleep-aid category that's quite relevant. It's a balance between education and entertainment. It's a matter of influencing beliefs and impacting behavior."

DTC advertising remains under fire, though the industry has been proactive in addressing hot-button issues. Some groups, such as Commercial Alert in Portland, Ore., still call for the abolition of all DTC ads. But the industry received a huge boost earlier this summer when the American Medical Association rebuffed an effort by two of its chapter members that asked for a resolution banning DTC ads. Instead, the AMA asked for a temporary moratorium on DTC marketing of newly approved drugs.

"I think in many respects that DTC advertising is still evolving," said Matt Giegrich, president and CEO of WPP Group's CommonHealth, Parsippany, N.J. "After all, it's really only 10 years old."