Public Citizen Urges FDA to Improve Drug Ad Requirements

In August 2017, the Food and Drug Administration (FDA) released an official notice to the public revealing its intention to consider allowing drug companies to reduce the amount of risk information they disclose to consumers in direct-to-consumer prescription drug television or radio advertisements (DTC broadcast ads).[1] The U.S. and New Zealand are alone in the developed world in allowing such ads.

In the notice, the FDA stated that it is considering requiring that companies disclose in DTC broadcast ads only a drug’s risks that are deemed severe, serious or actionable (those that a patient can detect and potentially mitigate), with a boilerplate disclaimer directing viewers of the ads elsewhere to see the rest of the drug’s risks.

In November 2017, we filed comments strongly opposing the FDA’s consideration of this watering down of the current DTC broadcast ad requirements.[2] Our comments noted that the study on which the FDA relied to justify its position[3] had several flaws. There was no true “apples to apples” comparison between the study groups to determine whether patients’ recall or comprehension of a drug’s risks varies based on how much risk information is provided in an ad. Nor did the study test presenting risk information in both audio and visual formats; instead it displayed the information in audio format only even though combined audio-visual format clearly has been shown to increase recall and comprehension of risk information. Moreover, the differences in recall and comprehension of drug ad risk information between the study groups were exceedingly small (and likely would have been even smaller were it not for the design flaws), limiting the relevance of the results to the real world.

In addition, the FDA has yet to finalize a 2010 proposed rule[4] (which it was mandated to implement in a 2007 law) that would have, among other things, banned drug companies from including distracting, pleasant imagery, text or sounds during the presentation of risk information in DTC broadcast ads.

In our final recommendations to the FDA, we called on the agency to finalize a rule that would do the following with regard to DTC broadcast ads:[5]

• Preserve the requirement to disclose all important risks of a drug, but require that severe, serious or actionable risks be disclosed in a more prominent and memorable fashion than other risks;
• Mandate that all important risks of an advertised drug be presented in both audio and visual formats; and
• Explicitly ban the use of any distracting, pleasant imagery, text or sounds during the risk-disclosure portion of DTC broadcast ads.

Further action by the FDA on this issue is pending.

References

[1] 82 FR 39598.

[2] Public Citizen. Comments to the FDA on the presentation of risk information in prescription drug direct-to-consumer broadcast ads. November 20, 2017. https://www.citizen.org/our-work/health-and-safety/comments-fda-presentation-risk-information-prescription-drug-direct-consumer-broadcast-ads. Accessed February 8, 2018.

[3] Betts KR, Boudewyns V, Aikin KJ, et al. Serious and actionable risks, plus disclosure: Investigating an alternative approach for presenting risk information in prescription drug television advertisements. Res Social Adm Pharm. 2017. pii: S1551-7411(17)30360-3036-1.

[4] 75 FR 15376.

[5] Public Citizen. Comments to the FDA on the presentation of risk information in prescription drug direct-to-consumer broadcast ads. November 20, 2017. https://www.citizen.org/our-work/health-and-safety/comments-fda-presentation-risk-information-prescription-drug-direct-consumer-broadcast-ads. Accessed February 8, 2018.