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Pharmaceutical companies spend billions of dollars annually advertising their products directly to consumers on TV.[1] Readers will probably not be surprised to hear that the average TV viewer in the U.S. may see nine drug ads per day, or up to 30 hours of drug ads per year.[2]
Although the Food and Drug Administration (FDA) regulates these ads and requires drug companies to submit all ads to the agency’s Office of Prescription Drug Promotion (OPDP), the agency does not approve the...
Pharmaceutical companies spend billions of dollars annually advertising their products directly to consumers on TV.[1] Readers will probably not be surprised to hear that the average TV viewer in the U.S. may see nine drug ads per day, or up to 30 hours of drug ads per year.[2]
Although the Food and Drug Administration (FDA) regulates these ads and requires drug companies to submit all ads to the agency’s Office of Prescription Drug Promotion (OPDP), the agency does not approve the ads, nor does it have sufficient staff or time to even review every ad. Predictably, a recent study published online in February in the Journal of General Internal Medicine revealed that drug ads often fail to fully adhere to FDA regulations governing direct-to-consumer ads.[3]
The researchers at Yale who conducted the study analyzed 97 TV ads for 60 different prescription medications that aired in the U.S. between January 2015 and July 2016. The most commonly advertised drugs were those used to treat inflammatory conditions, diabetes, and bowel or bladder problems.
Most troubling was the finding that 13 ads — for five different diabetes medications — suggested that the drugs were helpful for weight reduction, lowering blood pressure or both — uses that are not approved by the FDA (often called off-label uses). FDA regulations explicitly prohibit prescription-drug ads from promoting or even suggesting offlabel uses.[4] (Three years ago, Public Citizen’s Health Research Group filed a complaint with the FDA’s OPDP about the direct-to-consumer ads for five diabetes drugs — four of which had been cited by the Yale researchers — that appeared to promote off-label uses.[5])
FDA regulations also require a fair balance in the presentation of risks and benefits in prescription-drug ads[6]. However, the Yale researchers found evidence of a lack of such balance. For example, on average, the TV ads spent more time presenting information about the drugs’ benefits or FDA-approved uses (median 55 percent of ad time) than time presenting their risks (median 45 percent of ad time). The ads also more frequently ended with benefit information (39 percent of ads) than with risk information (18 percent of ads).
Most importantly, the presentation of risk information in all ads was accompanied by distracting visuals, such as frequent scene changes or characters dancing and singing, and nearly 80 percent had running text on the screen during the audio presentation of risks that was not related to the risks, such as “See our ad in Weight Watchers.” Such distractions decrease viewer retention of risk information.[7]
The researchers’ findings demonstrate the urgent need for FDA review and approval of all direct-toconsumer TV drug ads before they are aired to the public.
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 March 16, 2018.
[2] Klara K, Kim J, Ross JS. Direct-to-consumer broadcast advertisements for pharmaceuticals: Off-label promotion and adherence to FDA guidelines. J Gen Intern Med. 2018 Feb 26. doi: 10.1007/s11606-017-4274-9.
[3] Ibid.
[4] Electronic Code of Federal Regulations. 21 C.F.R. 202.1(e)(6)(i). March 12, 2018. https://www.ecfr.gov/cgi-bin/text-idx?SID=bdc94c3503a6fb037c7c47b6be5bb88f&mc=true&node=se21.4.202_11&rgn=div8. Accessed March 16, 2018.
[5] Public Citizen. Letter to Thomas Abrams, M.D., Director, Office of Prescription Drug Promotion, Food and Drug Administration. March 31, 2015. https://www.citizen.org/sites/default/files/2250.pdf. Accessed March 16, 2018.
[6] Electronic Code of Federal Regulations. 21 C.F.R. 202.1(e)(6)(i). March 12, 2018. https://www.ecfr.gov/cgi-bin/text-idx?SID=bdc94c3503a6fb037c7c47b6be5bb88f&mc=true&node=se21.4.202_11&rgn=div8. Accessed March 16, 2018.
[7] 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;36(2):236-245.
