New Legislation Would Compel FDA to Finalize Long-Overdue Rule on TV Prescription-Drug Ads

Fifteen years ago, Congress passed legislation as part of the Food and Drug Administration Amendments Act of 2007 that was intended to improve the disclosure of risk information in television advertisements for prescription drugs. The 2007 bill gave the Food and Drug Administration (FDA) a 30-month deadline to issue a final rule that would require such ads to present risk information in a “clear, conspicuous, and neutral manner.”[1]

Disturbingly, the FDA for more than a decade has flouted the will of Congress by failing to finalize this statutorily required rule on TV prescription-drug ads. In a long-overdue response to the agency’s recalcitrance, U.S. Rep. Abigail Spanberger, D-Va, on July 5, 2022, introduced the Banning Misleading Drug Ads Act, which would rectify the agency’s troubling inaction.[2]

In 2010, the FDA did issue 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.[3] Importantly, the proposed rule 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.[4]

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.”[5] 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.[6]

As of today, the FDA still has not issued a final rule to ensure that risk information in TV ads is presented in a clear, conspicuous and neutral manner. But the Banning Misleading Drug Ads Act would stipulate that if the FDA does not issue a final rule by 180 days after the date of enactment, the rule proposed by the agency in 2010 would automatically become a final rule that takes effect immediately on this date.

Given the endless barrage of prescription drug ads on TV, it is imperative that Congress immediately pass the Misleading Drug Ads Act to help ensure that consumers are not misled by TV ads that cleverly downplay the risks of prescription medications while hyping the benefits. In addition, the FDA must undertake much more aggressive enforcement actions against companies that violate the laws governing TV prescription-drug ads.
 

References

[1] 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 June 29, 2022.

[2] Congresswoman Abigail Spanberger, Virginia’s 7th District. Spanberger leads effort to crack down on drug companies & misleading ads, increase transparency for consumers. July 5, 2022. https://spanberger.house.gov/posts/spanberger-leads-effort-to-crack-down-on-drug-companies-misleading-ads-increase-transparency-for-consumers. Accessed July 7, 2022.

[3] 75 FR 15376.

[4] Sullivan H, Boudewyns V, O’Donoghue A, et al. Attention to and distraction from risk information in prescription drug advertising: An eye-tracking study. J Public Policy Mark. 2017;36(2):236-245.

[5] 75 FR 15376.

[6] Sullivan H, Boudewyns V, O’Donoghue A, et al. Attention to and distraction from risk information in prescription drug advertising: An eye-tracking study. J Public Policy Mark. 2017;36(2):236-245.