The United States and New Zealand stand unique in the world as the only two developed nations that permit direct-to-consumer advertising (DTCA) of prescription drugs. This practice is where pharmaceutical companies promote their prescription drug products directly to consumers, as opposed to solely targeting health care professionals.
In the United States, the FDA played a pivotal role in this development. In 1982, the FDA ruled that DTCA did not inherently violate its administrative law and regulations, and by 1985, the FDA announced it could adequately regulate DTCA while protecting public health. A significant turn occurred in 1997 when the FDA eased restrictions, allowing pharmaceutical companies to ramp up advertising directly to consumers. This policy change led to a surge in spending on prescription drug ads, with figures reaching nearly $10 billion a year. These regulations require that such ads must present a "fair balance" in the coverage of drug benefits to risks, including major side effects and contraindications in the main body of the advertisement123.
New Zealand's path to DTCA was more a result of legislative omission than active policy-making. The practice developed because the Medicines Act 1981 did not specifically prohibit it. Unlike the US, where regulation was more defined, New Zealand has undergone several reviews regarding DTCA. Following these reviews, despite many submissions advocating for a ban or tighter regulations, DTCA has continued, largely due to a lack of parliamentary support for a ban. The government has maintained a position of observing the effects of industry self-regulation, proposing regulatory schemes that aim to ensure that consumers receive balanced and truthful information. Efforts to harmonize the regulation of medicines between Australia and New Zealand have been made, but none have resulted in significant changes to DTCA practices4.
The draft Therapeutic Products Bill in New Zealand reflects ongoing efforts to regulate DTCA, proposing that it continues under the regulation of an independent authority, although the details of such regulation remain undecided5.
It is important to note that other countries, like Canada, allow some forms of drug advertising with limitations, while the European Union voted against DTCPA (Direct-to-Consumer Pharmaceutical Advertising) in 2008. The global rarity of DTCA can be attributed to various concerns about the impact of such advertising on public health, costs, and the relationship between patients and healthcare providers6.
The reasons for the continued allowance of DTCA in these two countries are complex and deeply rooted in their respective legislative and regulatory histories. Despite the ongoing debate and numerous reviews, the United States and New Zealand's policies on DTCA remain outliers in the international context.
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