DTC is, and has been, big business for all of the stakeholders involved, including the sponsors, the agencies, the media and the FDA. And it has demonstrably changed consumer health behavior. Even David Kessler, the FDA Commissioner during a period of rapid growth for DTC (1990 to 1997), and a fierce opponent during that time because he feared the ads would spark misinformation and confusion among consumers, eventually relented. In a famous speech at the DTC National in Boston in April 2002, he told the assembled industry advocates, “You've had a pretty good track record with DTC. I guess I was wrong"— a conclusion Dr. Kessler later rethought. But the promotion of prescription drugs to consumers has had a long and interesting history both before that speech and since. Many observers and analysts believe that the era of DTC advertising dawned in the summer of 1997, when the FDA lifted restrictions on broadcast advertising of branded commercials—clearly a watershed event, but not the first milestone in a long journey that actually began in the early 1980s. DTC: The Early Days The idea of stimulating consumer demand for prescription drugs through marketing promotion was barely a notion at the start of the 1980s. There were some minor but notable exceptions, such as Merck, Sharp and Dohme's FDA-approved ad for Pneumovax in 1981. It conveyed a message about the risks of pneumonia, encouraged consumers to go to their doctor for the vaccine, and let them know it was covered by Medicare. Boots Pharmaceuticals, the manufacturer of Rufen (ibuprofen), also began to do some consumer outreach around that time, initially with price-based print ads in
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