Miami’s Hard Rock Stadium hosts Super Bowl LIV this weekend, pitting the champions of the American Football Conference Kansas City against the champions of the National Football Conference, the San Francisco 49ers. It’s been 50 years since the Chiefs have played in the Super Bowl, when they beat the Minnesota Vikings for the Lombardi Trophy. The 49ers have taken home the Lombardi 5 times, but missed a 6th time when playing the Baltimore Ravens in 2013. Between now and the big game there will LOTS of advertisements, with new ads for cars, trucks, insurance, beer as well as prescription and non-prescription medicines.
I’m often asked, “Why do some drug advertisements on television mention the risks of the medicine they are promoting, while others don’t?”
That’s a great question. One reason is that there are 2 main types of medicines being advertised, prescription and non-prescription medications, with one set of rules for direct to consumer (DTC) advertising of prescription medicines, and another, very different set for non-prescription or OTC (over-the-counter) medicines. The Food and Drug Administration (FDA) controls the advertising rules for prescription medicines, while the Federal Trade Commission is responsible for the rules regarding advertising of non-prescription or over the counter (OTC) medicines.
Inside the FDA, the Office of Prescription Drug Promotion (OPDP) is responsible for regulating the marketing of prescription medicines. OPDP’s mission is to protect public health by assuring that prescription drug information used in advertising is truthful, balanced and accurately communicated, whether it’s directed at health care providers such as doctors and pharmacists, or aimed directly at consumers. In contrast, the advertising of OTC medicines regulated by the Federal Trade Commission and is much less strict.
You won’t always hear about the side effects of a medicine during an advertisement because the FDA created 3 different categories of direct to consumer advertisements that a manufacturer of a prescription medicine can use, and only one of those categories requires them to mention any risks of taking it.
The categories of DTC advertising include help seeking ads, product claim ads, and reminder ads. Help seeking advertisements mention a particular condition, such as depression, arthritis, or overactive bladder, then direct you to ask your doctor for more information about it. No medicines are mentioned in this type of ad, but if you look closely, you’ll usually see the name or logo of the drug manufacturer sponsoring it somewhere on the screen.
Product claim ads are the most familiar to people because they mention the type of condition the medicine has been approved to treat, give its brand and generic name, and include some benefits and risks associated with taking it. Product claim ads often use cartoons, celebrity spokespeople or actors to play satisfied patients; then, near the very end you hear a list of risks of taking the medicine, including death. The balance between benefits and risks is important; in this category of marketing, the advertisement MUST mention potential serious risks if they are presenting benefits to their audience.
The third type of prescription medicine advertisement for DTC marketing is a reminder ad. Reminder ads are short, giving only the brand name of the medicine, not what it treats or any of its benefits. Reminder ads connect us with previous advertising by echoing the visual marketing elements seen in the product claim ads for the product, like showing two people watching a sunset sitting in bathtubs placed side-by-side.
DTC advertising is controversial. On one hand, those who support DTC marketing state that it’s useful to consumers because it encourages people to talk to their physician about a health condition they may have. DTC advertising can also help remove the stigma of a particular condition, such as depression or erectile dysfunction.
Opponents of DTC advertising are concerned that it promotes increased medication use and even overuse of drugs for conditions that have non-drug treatments or less expensive treatments available. They also fear that not enough attention is paid to the risks of a new medicine, like serious side effects. Marketers want their product presented in the best possible light, and false or misleading claims can slip in.
In contrast, DTC advertising of a non-prescription product doesn’t have to mention ANY side effects, because the FTC doesn’t require it. There is continuing concern about this lack of balance, especially when a prescription medicine gets approval to become OTC, such as omeprazole (Prilosec®) or naproxen (Aleve®). Just because a medicine no longer requires a prescription doesn’t mean the risks of having side effects magically disappear.
The only type of advertisement that forces the manufacturer to mention the risks of taking a particular medicine is a product promotion advertisement of a prescription-only medicine. With reminder ads, help seeking ads and OTC medicine advertisements, there aren’t any serious side effects mentioned because the manufacturer is not required to include that information when advertising their product.
