Claritin the first of the big spenders
Claritin, approved in 1993 and launching DTC in 1995, wasn’t the first big brand advertised to consumers, but it was the first really huge spender of the broadcast DTC era.

The Schering-Plough cash cow ran print ads and unbranded broadcast reminder ads at first, but switched over to branded ads with its “Blue skies” campaign, by CommonHealth’s Thomas Ferguson Advertising, with the FDA’s liberalization of broadcast advertising requirements in 1997. With older competitors like Seldane and Hismanal out of the way and newer drugs Zyrtec and Allegra still in development, Claritin had the market for antihistamines all to itself. Schering committed to a massive, broadcast-heavy multi-channel consumer campaign aimed at establishing universal brand awareness.

“The market kept growing and the brand kept responding,” says Matt Giegerich, then an account manager on Claritin at Thomas Ferguson and now president of CommonHealth. “Their ambition and optimism changed the game.” Claritin DTC spending peaked in 1998, at $142 million in measured media, according to TNS Media Intelligence data, but remained strong over the course of five line extensions and a 2002 OTC switch.

“They set the bar very high for spending,” says Ray Hilton, SVP and senior account director at BBDO. “Allergy was a big category for DTC, since there weren’t really bad side effects, but Claritin was a big brand and a big spender.” Meanwhile, the blue skies motif became one of the longest-running in the history of branded pharmaceuticals, permeating even the packaging and setting the standard for integrated brand communications.

A quarter-century of rewriting the rules

It’s tempting to think of 1997 as being the dawn of DTC advertising. In that year, the FDA released its draft guidance effectively enabling broadcast ads by allowing advertisers to forgo the requirement that they scroll or read the entire brief summary, provided they met an “adequate provision” standard for risk information.

But drug marketers were dipping their toes in the DTC waters long before then—and sometimes finding it a bit choppy. The first print ad, for Merck’s Pneumovax, appeared in Reader’s Digest in 1981. In 1982, the FDA prompted Lilly to retract a press kit for its NSAID Oraflex, citing the “false and misleading” provision of risk information. MM&M wrote at the time, “Many physicians said that they felt pressured by their patients into prescribing a product that they might not otherwise have recommended.”

The following year, the agency made Boots Pharmaceuticals pull TV ads for its Ibuprofen brand Rufen. The ads, featuring dapper Brit CEO John D. Bryer, boasted that Rufen was cheaper than Motrin but made no efficacy claims, and so did not include PI info. Under pressure from doctors, FDA was adamant. “We thought that way we could navigate this quagmire of FDA indecisiveness, but they were really grappling with how to address labeling and issues of communication,” said Liz Moensch, who was then head of marketing at Boots and is now president and CEO of The Medici Group. A brief moratorium on consumer advertising followed, lapsing in 1985.

Undaunted, the makers of products in relatively safe categories such as “cosmeceuticals,” allergy and HRT pushed ahead with print ads and even some experimental early broadcast ads. Marion’s Seldane may have been the first brand after Rufen on-air, running unbranded direct-response ads by Medicus in which a nurse advised viewers to talk to their doctor if their allergies were new. Upjohn’s Rogaine, handled by Klemtner, appeared soon after.

A burst of big campaigns followed in the early ’90s, including work for Ciba-Geigy’s Estraderm, handled by Ogilvy, Wyeth’s Premarin, executed by Rubin, Reid, Noto and Ehrenthal and Associates, and Glaxo Wellcome’s Imitrex, handled by Klemtner.

1997: FDA approves broadcast DTC draft guidance, Aug. 8, effectively enabling broadcast DTC by eliminating requirement that ads present the entire brief summary.

1999: FDA clarifies risk information requirements for broadcast DTC, Aug. 9, allowing for the presentation of a “major statement” of serious risks in lieu of full risk information. Schering-Plough spends $124 million on consumer advertising for Claritin.

2004: Merck withdraws heavily advertised Vioxx on safety concerns, Sept. 30, providing a touchpoint for public ire over drug prices and throwing a shadow over consumer promotion

2005: Sepracor launches Lunesta, April 4, spends $215 million on consumer advertising over the next eight months. Sanofi-Aventis plunks down a cool $88 million defending Ambien’s category leadership

2005: Pharmaceutical Research and Manufacturers of America releases its Guiding Principles on Direct to Consumer Advertisements About Prescription Medicines, Aug. 2, heading off Congressional action with industry self-regulation.