What do our pharmaceutical product advertisements indicate about our national ideals, given the myriad of advertisements seen on the Internet, TV, in magazines, or heard on the radio here in the United States?
Interestingly, the United States and New Zealand are the only developed nations that allow direct -to-consumer (DTC) advertising (Liang & Mackey, 2011). Our DTC advertising practice has a rich history beginning with the 1962 amendments to the Food, Drug, and Cosmetic Act which transferred responsibility of regulating product promotion to the Federal Trade Commission (FTC). This amendment did not explicitly prohibit the marketing of pharmaceutical products to consumers.
In the early 1980s, a few pharmaceutical companies experimented with DTC advertising. In 1982, the FDA instituted a moratorium on this practice until 1985 when the FDA indicated that all DTC advertising must meet the same advertising requirements aimed at health care professionals (Calfee, 2002). It was in 1997 that the FDA issued a guidance document that essentially reinterpreted the regulations without rewriting them (Calfee, 2002). Since 1997, DTC advertising has steadily increased by some accounts over fourfold between 1998 and 2009 (Liang & Mackey, 2011).
Critics of this practice indicate that DTC advertising contains limited information about the risk and benefit of products, and may often be misleading or inaccurate (Wolfe, 2002). Vioxx (rofecoxib) is an example of how aggressive DTC advertising of blockbuster products, where the comprehensive safety profile is not well-established, can result in their use beyond the label (Vastag, 2007). Does this type of DTC advertising example indicate that our American capitalism outweighs our concern for public health? If so, is this the message we want to send in the industry? By most accounts, a full reversal of the DTC advertising allowance would not be easy given our propensity to protect free speech (Liang & Mackey, 2011).
So if a full ban is not the answer, what is? In an article by Liang and Mackey (2011), they suggest that a reformed DTC advertising policy and regulation focusing on the risk/benefit disclosure, among other things, may have the advantage of ensuring safe and effective advertising, while allowing pharmaceutical companies the opportunity to recoup the high development costs of product development.
References
Calfee, J.E. (2002). Public Policy Issues in Direct-to-consumer Advertising of Prescription Drugs.
Liang, B.A., and Mackey, T. (2011). Reforming direct-to-consumer advertising. Nature Biotechnology, 29(5), pp. 397-400
Vastag, B. (2007). The policy outlook from the Hill. Nature Biotechnology, 25, 267
Wolfe, S. (2002). Direct-to-Consumer Advertising — Education or Emotion Promotion? New England Journal of Medicine. 346, pp. 524–526
Follow Perficient’s Life Sciences blog on Twitter via @Perficient_LS.
Connect with Perficient on LinkedIn here.
