Most Direct-To-Consumer Drug Advertisements Do Not Adhere To FDA Guidelines

Few DTC drug advertisements fully adhere to FDA guidelines, the overall quality of information provided in DTC advertisements is low, and some advertisements market off-label indications.

madinamerica
Shannon Peters March 30, 2018

A new study, led by Joseph Ross, associate professor of Medicine and of Public Health at Yale University School of Medicine, examines direct-to-consumer (DTC) drug advertisements. The results of the study, published in the Journal of General Internal Medicine, find that most DTC advertisements in the US do not fully adhere to US Food and Drug Administration (FDA) guidelines, the overall quality of information is low, and some market off-label indications despite this being explicitly prohibited.

“Though proponents argue that DTC advertising is educational and empowering for consumers, our findings suggest that the information provided is unreliable and potentially misleading,” write the authors.

The FDA has allowed DTC advertising in the US since 1985. Today, someone who watches an average amount of television will watch about nine drug advertisements each day, or 30 hours of advertisements a year. Drugs marketed through DTC advertising have increased demand by patients, higher rates of prescribing, and as a result, higher sales. Those who support DTC advertising suggest it empowers people to make informed medical decisions. Others who are cautious of DTC advertising worry it can lead to inappropriate or over-prescribing and have called to end DTC advertising.

The FDA requires that drug companies provide the Office of Prescription Drug Promotion (OPDP) with all advertisement materials and has regulations for what can and cannot be included in an advertisement. For example, DTC advertisements must list major risks in audio and are prohibited from suggesting any off-label uses for a drug (“off-label” refers to using a drug for a reason that has not been approved by the FDA). However, because of limited resources, the OPDP does not review every advertisement, and previous research has shown that many DTC advertisements do not follow FDA guidelines.

The aim of the current study, as described by the researchers, was to “assess the degree to which recently aired DTC ads for prescription drugs adhered to FDA regulations and guidelines” and “examine whether off-label use was suggested.” The researchers reviewed 97 DTC advertisements that aired in the US between January 2015 and July 2016.

The researchers find that the most common types of drugs marketed through DTC advertising are for inflammatory conditions (18%) and diabetes (16%). Psychiatric or neurological drugs made up 10% of the drug indications advertised. Over three quarters (76%) of the drug indications were for chronic conditions. Based on the traits of the main characters in the commercials, drugs were most commonly marketed to young or middle aged women.

“All advertisements included an approved use for the drug,” find the researchers. While there were no blatantly false statements in the advertisements, the researchers did find the information to be low quality and sometimes misleading. In addition, the researchers find that 13% of commercials, all for diabetes medication, “suggested non-FDA-approved—or off-label—uses, all of which were for weight loss and/or reduction in systolic blood pressure.”

The authors note, “only 26% (n = 25) of ads contained quantitative efficacy information” (e.g., the percentage of people who had successful results from a drug). In addition, “none of the commercials contained quantitative information regarding risks or side effects,” find the researchers. Although advertisements are required to audibly list all major risks, 22% had at least one risk only in the running text.

Another important finding was that 60% of DTC advertisements discussed potential savings or payment methods. The researchers highlight that, although drug coupons could reduce costs in the short term, the savings are often time-limited, and may result in a higher societal cost if people are choosing higher cost drugs over less expensive options.

The researchers summarize, “Our findings demonstrate that the quality of information in DTC television ads is low: none described drug risks quantitatively; only one-quarter described drug benefits quantitatively, and suggestions of off-label promotion were common for diabetes medications.”

“The promotion of off-label indications, poor quality of information, distracting risk presentations, and the fact that risks are never quantified could distort the perception of benefit and risk information,” highlight the authors. Therefore, the researchers call for more detailed regulations for what quantitative information about drug risks is required in DTC advertising. They also suggest the FDA charges a “user fee” to DTC advertisers, which could then fund more comprehensive oversight of advertisements. The authors conclude by reminding us why tighter regulations on DTC advertising are essential:

“Broadcast DTC advertising could lead patients to make healthcare decisions and request certain expensive, brand-name medications based on ads containing low-quality and incomplete information.”

Patients deserve quality, comprehensive information about drug benefits and risks in order to provide informed consent and be truly empowered in their healthcare decisions. In their current form, most DTC advertisements are misleading rather than promoting informed consent.

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Klara, K., Kim, J., & Ross, J. S. (2018). Direct-to-consumer broadcast advertisements for pharmaceuticals: Off-label promotion and adherence to FDA guidelines. Journal of General Internal Medicine. Advance online publication. doi:10.1007/s11606-017-4274-9 (Link) 

Thank You Ms Peters and MIA.