Food and Drug Administration (FDA) is a Department of Health and Human Services agency and has eight centers/offices. The agency grew from a single chemist in the U.S. Department of Agriculture in 1862 to a staff of around 9,100 employees and a budget of $1.294 billion in 2001 (History of the FDA). According to its Web site, the FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation (FDA's mission statement). And, the FDA is responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health. The agency's impact on the commercial market is enormous; it oversees items accounting for one fourth of every dollar spent by consumers (History of the FDA). Direct-to-consumer (DTC) advertisement rules established by the FDA illustrate just how much this agency's regulations influence markets and that the agency doesn't always do its job.

             Pharmaceutical companies began direct-to-consumer (DTC) advertisements in 1985 after the FDA lifted its ban on them and the FDA has continued to relax its regulations (Macias and Stavchansky, 2003/2004). DTC advertising began to appear after the initial ban was lifted, but it was minimal because of requirements to add a lengthy brief summary detailing information regarding the prescription drug. In 1997, the FDA removed the requirement to include the "brief summary" in broadcast advertising, and drug manufacturers began to expand their television campaigns. In 1999, the FDA outlined an approach "that the FDA believes can fulfill the requirement for adequate provision in connection with consumer-directed broadcast advertisements for prescription drug and biological products.