FDA Policy/General

Pro and Con Opinions on Broadcast Ad ‘Major Statement’

David McFarland

— 2 min read
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Stakeholders are responding with agreement and objection to an FDA request for information and comment on its proposal to change requirements for the content of the so-called major statement that outlines prescription drug risks in direct-to-consumer (DTC) broadcast ads. The National Association of Broadcasters says the agency should modify its rules to allow advertisers to use a limited risk plus disclosure approach in DTC drug advertising. “The rule change will enhance the consumer benefits of DTC advertising by making ads easier to comprehend, making the most important risks more apparent, and reducing the potential for therapeutic noncompliance from fear of side effects,” the trade association says. “Modifying the rules also will allow broadcast viewers and listeners to get clearer, more relevant information and spur competition in the advertising market by making radio a more viable outlet for DTC advertising.”

The Coalition for Healthcare Communication (CHC) says its position is that “less is more in advertising directed at consumers and that shorter, simpler disclosures are most likely to lead to robust doctor-patient conversations and better health outcomes.” The trade group says it agrees with FDA that a DTC ad should provide clear and useful information to the ad’s audience. “Broadcast advertising, on its face, is not the more effective venue for risk and side effect information,” it adds, “but the coalition believes that a ‘limited risk with disclosure’ approach would be most likely to achieve a balance between not enough risk information and too much risk information.”

CHC says that relying on the current major statement requirement in DTC broadcast ads does not achieve the appropriate balance because the major statement may be too long and complex for most, if not all, broadcast ads, resulting in (1) reduced consumer comprehension; (2) minimization of the most important risk information; and (3) potentially therapeutic noncompliance due to fear of side effects.

In its comment letter, Pharmaceutical Research and Manufacturers of America (PhRMA) emphasizes that: 

  •          there are public health benefits to DTC broadcast advertising;
  •          PhRMA recognizes the importance of communicating benefit and risk information in clear terms in DTC ads so patients may gain a better understanding of certain known risks regarding such medicines;
  •          PhRMA supports a “limited risk plus disclosure” strategy for the major statement; and
  •          any “limited risk plus disclosure” strategy should focus only on risks that are “serious and actionable.”

The association says it will be important that FDA issue new clarifying regulations and create an enhanced advisory comment process for proposed DTC broadcast ads.

Finally, Public Citizen says it believes the agency study that FDA is using to justify its proposal to reduce the amount of risk information in DTC broadcast ads was “fundamentally incomplete and flawed and does not address more important factors already known to affect the comprehension and recall of risk information disclosed in DTC broadcast ads.

It says the agency should issue a legally binding final rule amending the regulations governing DTC ads for prescription drugs to require that the disclosure of risk information in the major statement be clear, conspicuous, and neutral. It calls on FDA to maintain current requirements about which risks must be disclosed and continue to require “a brief summary of all necessary information related to side effects and contraindications,” that may include certain important, non-severe, non-serious, and non-actionable risks, while also requiring that severe, serious, or actionable risks be disclosed more prominently.

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