Viewers of this year’s Super Bowl saw several medical device and pharmaceutical commercials. Although Super Bowl ads cost manufacturers millions of dollars, studies have shown they increase sales. For example, researchers studied two prescription drug ads from the 2015 and 2016 Super Bowls and found the number of prescriptions increased by almost 100% and 275%, respectively. According to the researchers’ model, the number of prescriptions for the drugs would have only increased by 40-90% without the ads.1
The Super Bowl is not the only time pharmaceutical manufacturers advertise to consumers. Each year manufacturers spend millions of dollars on commercials, radio ads, print ads, etc. While ads increase pharmaceutical sales and awareness, there are concerns they lack crucial information and steer consumers toward a medication that may not be appropriate for their condition.
Direct-to-Consumer Advertising Regulations
Direct-to-consumer (DTC) pharmaceutical advertising promotes prescription drugs to the general public as opposed to targeting healthcare providers. DTC ads are regulated by the Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion which oversees prescription drug ad activities and ensures ads do not violate the Federal Food, Drug, and Cosmetic Act. The Act requires all prescription drug ads to summarize information relating to side effects, contraindications, and effectiveness.2
The FDA has three categories prescription drug ads fall under: product claim ads, reminder ads, and help-seeking ads. Product claim ads name the drug, the condition it treats, and state its benefits and risks. Reminder ads name the drug but do not state the drug’s use. Help-seeking ads describe a disease or condition without recommending or suggesting specific drugs.3
Prescription drug ads do not need to tell consumers all the drug risks upfront. Prescription drugs with serious risks, including drugs that can cause severe injury, addiction, or withdrawal effects, are allowed to be advertised to consumers. The FDA does not approve prescription drug ads before the public sees them. Therefore, the public may see ads that violate the law before the FDA can act.4
The Effects of Direct-to-Consumer Advertising
The American Medical Association (AMA) recently investigated the connection between drug manufacturer spending on DTC ads and prescription drug characteristics. They stated, “Direct-to-consumer advertising is associated with increased patient requests and increased clinician prescriptions for advertised products.” While the AMA believes DTC ads may cause more informed discussions amongst patients and clinicians, they also believe increased requests could create a burden for clinicians. They stated it could, “lead to distrust and a worsened relationship between the clinician and patient, especially when patient requests are not granted.” There are multiple reasons clinicians may not want to prescribe the advertised drug. For example, there may be lower-cost alternatives available, more effective alternatives, or similar alternative treatments that are on the patient’s formulary lists.
The AMA’s study concluded that of the 150 top-selling US drugs in 2020, a significant portion of manufacturers’ DTC ad spending was for drugs rated as having lower added clinical benefits.5 The lead researcher of the study stated, “The findings could suggest pharma firms are aiming promotional dollars directly towards consumers, rather than clinicians, as part of a ‘strategy to drive patient demand for drugs that clinicians would be less likely to prescribe.”
The AMA and other health organizations oppose DTC advertising and push to outlaw it. They argue DTC advertising incentivizes drug companies to exaggerate the benefit of their drugs without detailing possible side effects. The United States and New Zealand are the only two countries that allow prescription drugs to be advertised directly to consumers.6
DTC ads do not tell the whole story. Advertised prescription drugs may have severe risks and low clinical value that is not expressed in the ad, which could be costly to patients and their pharmacy benefit plans.
National CooperativeRx encourages patients to learn more about the drugs they see advertised before requesting a prescription from their clinicians.
For more information about prescription drug advertising, click here.
- Super Bowl Ads Dramatically Boost Sales of Prescription Drugs. Inside Science. Accessed February 24, 2023. https://www.insidescience.org/news/super-bowl-ads-dramatically-boost-sales-prescription-drugs
- Research C for DE and. OPDP Frequently Asked Questions (FAQs). FDA. Published online July 29, 2021. Accessed February 24, 2023. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/opdp-frequently-asked-questions
- Center for Drug Evaluation and Research. Basics of Drug Ads. U.S. Food and Drug Administration. Published June 19, 2015. https://www.fda.gov/drugs/prescription-drug-advertising/basics-drug-ads
- Research C for DE and. Prescription Drug Advertising | Questions and Answers. FDA. Published online February 3, 2020. https://www.fda.gov/drugs/prescription-drug-advertising/prescription-drug-advertising-questions-and-answers
- DiStefano MJ, Markell JM, Doherty CC, Alexander GC, Anderson GF. Association Between Drug Characteristics and Manufacturer Spending on Direct-to-Consumer Advertising. JAMA. 2023;329(5):386-392. https://doi.org/10.1001/jama.2022.23968
- Hart R. Here’s Why Big Pharma Spends More On Ads Pushing Lower Benefit Drugs, Study Suggests. Forbes. Accessed February 24, 2023. https://www.forbes.com/sites/roberthart/2023/02/07/heres-why-big-pharma-spends-more-on-ads-pushing-lower-benefit-drugs-study-suggests/?sh=25934ab1711b