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Abstract

The issue of required disclaimers in direct-to-consumer (DTC) advertising of pharmaceuticals boiled to the surface in May 2019, when the Centers for Medicare and Medicaid Services (CMS) published a final rule requiring the disclosure of a drug’s price in DTC ads. The idea is not a new one––the American Medical Association (AMA) adopted a resolution recommending just such a required disclosure in June 2017. For a number of reasons, even if the proposal is implemented it may not have much effect. Consumers may see price as an indicator of effectiveness, just as a high-priced car is expected to be superior to a lower-priced car, and insurance coverage may reduce patients’ concerns about a high-price for a drug. The significance of drug prices to consumers is further complicated both by the “market-distorting effects of third-party payors” and the requirement for consultation with and prescription by a licensed physician whose decisions may also be impacted by third-party payors, but is not necessarily affected by the list prices of drugs. However, the thesis of this article is not that disclosing prices in DTC ads is a bad idea, but that providing consumers with information about how effective advertised drugs are likely to be for them would provide information that patients need regardless of their insurance or financial status. Additionally, it would likely have a greater impact on the pharmaceutical marketplace. If the problem with DTC ads, as the AMA stated in its proposal to require price disclosures, is that “patients pressure physicians to prescribe certain medications that cost more than lower-cost alternatives and are not necessarily as efficacious,” then requiring DTC ads to provide consumers with clear information about the effectiveness of the advertised drug would be an even more powerful solution. There is a growing awareness of the need to require disclosures of expected effectiveness in pharmaceutical DTC marketing. Currently, consumers are told about the general condition for which a drug is used: e.g. “Drug X is approved for the treatment of major depressive disorder,” or “Drug X has been proven effective for the treatment of depression”; but rarely are consumers given information about the average benefit achieved in clinical trials or in post-market studies. This is a particular problem in DTC advertising for prescription pharmaceuticals. An article, in The New York Times by Elizabeth Rosen, highlighted the problem of DTC ads that are likely to mislead consumers about a drug’s effectiveness and provided this example: “Another ad promoted Jublia, a new topical drug for toenail fungus that costs thousands of dollars for a full course of treatment. Complete cure rates in studies—under 20 percent after 48 weeks of use—aren’t mentioned in the ads.” While the problem is becoming well known, as the New York Times article illustrates, the FDA regulation of pharmaceutical marketing is significantly constrained by the First Amendment’s protection of commercial speech, which would almost certainly make a ban on DTC pharmaceutical ads unconstitutional. This article provides an approach to FDA regulation of DTC ads that would address the problem within the limits of the First Amendment’s protection for commercial speech and provide patients with the information they need most to sort through the glossy promotional advertisements created by pharmaceutical companies and their ad agencies.

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