Each year, the first weekend in February the Super Bowl pits the American Football Conference’s champion team against the champions of the National Football Conference. Between now and the big game, there will be a LOT of advertisements featuring cars, trucks, insurance,and beer, along with ads for 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?”
One reason is that there are 2 main types of medicines being advertised: prescription-only medicines and non-prescription medications. There is one set of rules for direct to consumer (DTC) advertising of prescription medicines, and other regulations for non-prescription or OTC (over-the-counter) medicines.
The Food and Drug Administration (FDA) controls the advertising rules for prescription medicines. At the same time, the Federal Trade Commission is responsible for the laws regarding advertising of non-prescription or over the counter (OTC) drugs.
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. Its role is to assure that prescription drug information used in advertising is truthful, balanced, and accurately communicated.
The FDA reviews two types of drug marketing: material directed at healthcare providers such as doctors and pharmacists and directly at consumers.In contrast, the advertising of OTC medicines is regulated by the Federal Trade Commission and is much less strict.
You may not always hear the side effects of medicines during an advertisement. That’s because the FDA created 3 different categories of direct to consumer advertisements that manufacturers of prescription medicine can use, with only one of them requiring that drug makers mention any risks associated with their products.
The categories of DTC advertising include help-seeking ads, product claim ads, and reminder ads. Help-seeking ads mention a particular condition, such as depression, arthritis, or overactive bladder, and then direct you to ask your doctor for more information. No medicines are mentioned in this 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 mention the type of condition the medicine has been approved to treat plus the drug’s brand and generic names. They include some benefits and risks associated with taking it.
Product claim ads often use cartoons, celebrity spokespeople, and actors to play satisfied patients. Near the end, you hear a list of risks of taking that medicine, including death.
The balance between benefits and risks is essential. In this category of marketing, the advertisement MUST mention potential severe risks if they present 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 medicine’s brand name, not what ailment 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 disease, such as depression or erectile dysfunction.
Opponents of DTC advertising are concerned that marketing specific drugs to consumers promotes medications for conditions that have non-drug treatments or less expensive treatments available. They worry that advertising medications will encourage the overuse of drugs. They also fear that not enough attention is paid to the risks of new medicines, 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 drug no longer requires a prescription doesn’t mean the risks of having side effects will magically disappear.
Drug manufacturers only have to mention the risks of taking a particular medicine in a product promotion ad of a prescription-only drug.
With reminder ads, help-seeking ads, and OTC medicine advertisements, there aren’t any serious side effects mentioned. The drug manufacturer is not required to include that information when advertising their product.
