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Direct to consumer – DTC

Direct to consumer – DTC

Direct-to-consumer advertising (DTC advertising) or Direct-to-Consumer Pharmaceutical Advertising (DTCPA) refers to the marketing of pharmaceutical products advertising directed toward patients, rather than healthcare professionals. This controversial tactic is allowed only in the USA and New Zealand. Most other countries don’t allow DTCPA at all; however, Canada does allow ads that mention either the product or the indication, but not both.

The Food and Drug Administration is responsible for regulating DTC advertising in the United States. The FDA’s latest version of guidelines, though still in draft form, for pharmaceutical drug advertising was updated in 2009. Forms of DTC advertising include TV, print, radio and other mass and social media. There are ethical and regulatory concerns regarding DTC advertising, specifically the extent to which these ads may unduly influence the prescribing of the prescription medicines based on consumer demands when, in some cases, they may not be medically necessary.

Types of Direct-to-Consumer Drug Advertisements and FDA Regulatory Requirements

Type of Ad Requirement
Product claim ad: Names a drug and the indication(s); makes claims regarding safety and efficacy Product claims are made, so “fair balance” does apply and risks are required to be included in a “brief summary.”
or (for broadcast ads only)
Risks must be included in “major statement,” and “adequate provision” for access to a “brief summary” is required.
Reminder ad: Names a drug, dosage form, and possibly cost, but not its uses No product claims are made, so “fair balance” doesn’t apply and mention of risks in “brief summary,” “major statement,” or “adequate provision” is not required. However, the FDA does not allow this type of ad for drugs with serious risks (i.e., a boxed warning).
Help-seeking ad: Describes a disease or condition but doesn’t mention a specific drug that treats it No product is mentioned, nor are any claims made, so “fair balance” doesn’t apply; inclusion of risks in “brief summary,” “major statement,” or “adequate provision” is not required.

About Piotr Wrzosiński

Piotr Wrzosinski is a sociologist focused on digital marketing in highly regulated industries. He combines experience from top players in tobacco, financial services, and pharma with a passion to the content marketing and technology. All opinions posted are his own unless stated otherwise.
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