FDA Dragging Its Feet on Improving Presentation of Risk Information in TV Drug Ads

Each year, the pharmaceutical industry spends several billion dollars bombarding U.S. consumers with television advertisements that hawk expensive brand name prescription drugs.[1] Strikingly, the U.S. and New Zealand are the only two countries that allow prescription drugmakers to advertise their products directly to consumers.

The Food and Drug Administration (FDA) currently requires that TV prescription-drug ads include a brief summary of the advertised drug’s major risks in the audio or audio and visual parts of the presentation.[2] The FDA further requires that each drug ad present a fair balance between information about the drug’s risks and the information about its benefits.[3] But too often, the presentation of risks and benefits in TV drug ads is not fairly balanced.

In 2007, Congress passed legislation aimed at improving the disclosure of risk information in TV ads for prescription drugs by mandating that ads present this information in a “clear, conspicuous, and neutral manner.”[4] The bill directed the FDA to issue regulations implementing these new requirements within 30 months.

In 2010, the FDA issued for public comment a proposed rule that, when finalized, would have implemented the regulatory changes for TV ads that were mandated by Congress in 2007.[5] Importantly, the proposed rules would have banned the use of distracting statements, text, images or sounds during the communication of the advertised drug’s major risks. A 2017 FDA-commissioned study confirmed that inclusion of distracting images and sounds during presentation of risk information in a TV drug ad reduced retention of that information.[6]

In addition, in its discussion of the proposed rule in 2010, the FDA stated that the agency believed that “presenting the major [risk] statement in both the audio and visual portions of television ads could enhance the clarity, conspicuousness, and neutrality of this information.”[7] The FDA invited the public to comment on whether the final rule should require such dual presentation of major risks in TV drug ads. The FDA itself is well aware of research showing that conveying information in both audio and visual formats has been found to increase memory and comprehension of that information.[8]

Shockingly, the FDA has never finalized the proposed rule that was first mandated by Congress more than a decade ago. Given the endless barrage of prescription drug ads on TV that are carefully crafted to maximize consumers’ retention of benefit information while minimizing retention of risk information, it is imperative that the FDA finally issue updated rules on TV drug ads along the lines first proposed in 2010.

References

[1] Robbins R. Drug makers now spend $5 billion a year on advertising. Here’s what that buys. March 9, 2016. STAT. https://www.statnews.com/2016/03/09/drug-industry-advertising/. Accessed December 10, 2017.

[2] 21 C.F.R. §202.1(e).

[3] 21 C.F.R. §202.1(e)(5)(ii).

[4] Food and Drug Administration Amendments Act of 2007, Public Law 110-85. September 27, 2007. https://www.gpo.gov/fdsys/pkg/PLAW-110publ85/html/PLAW-110publ85.htm. Accessed December 11, 2017.

[5] 75 FR 15376.

[6] Sullivan HW, Boudewyns V, O’Donoghue A, et al. Attention to and distraction from risk information in prescription drug advertising: An eye-tracking study. J Public Pol Marketing. 2017. In press. doi.org/10.1509/jppm.16.013.

[7] Ibid.

[8] Sullivan HW, Boudewyns V, O’Donoghue A, et al. Attention to and distraction from risk information in prescription drug advertising: An eye-tracking study. J Public Pol Marketing. 2017. In press. doi.org/10.1509/jppm.16.013.