Clear answer to your medical questions

Football fans and advertisers look forward to the Super Bowl, held every year in early February. The Raymond James Stadium in Tampa, Florida, hosts Super Bowl LV this weekend. The National Football League champion Tampa Bay Buccaneers meet the Kansas City Chiefs, the American Football Conference champs. It’s the first time a Super Bowl will be held at the home stadium of one of the teams competing in it. Between now and the big game, there will be many new commercials featuring cars, trucks, insurance, and beer, along with advertisements 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 set of rules governs direct to consumer (DTC) advertising of prescription medicines. There are different rules for how non-prescription or OTC (over-the-counter) medicines can be promoted. The Food and Drug Administration (FDA) controls the advertising rules for prescription medicines. The Federal Trade Commission is responsible for the advertising of non-prescription or over the counter (OTC) drugs. 
Inside the FDA, the Office of Prescription Drug Promotion (OPDP) is responsible for regulating prescription medicines’ marketing. OPDP’s mission is to protect public health by assuring that information used to promote prescription drugs is truthful, balanced, and accurately communicated to doctors, pharmacists and consumers. In contrast, the advertising of OTC medicines regulated by the Federal Trade Commission and is much less strict. 
The side effects of medicines are not always mentioned during their advertisements because the FDA created 3 different drug marketing categories that manufacturers of prescription medication can use. Only one of those advertising categories requires the manufacturer to list the risks associated with taking their medicine. 
The categories of DTC advertising include help-seeking ads, product claim ads, and reminder ads. Help-seeking drug ads mention a particular condition, such as depression, arthritis, or overactive bladder, then direct the consumer to ask their doctor for more information about it. No medicines are mentioned in this type of advertisement. If you look closely, you’ll usually see the drug name or logo of the drug manufacturer sponsoring it somewhere on the screen or the page.  
Product claim ads state the type of condition the medicine has been approved to treat, its brand and generic name, and give some benefits and risks associated with taking it. 
Product claim ads will often use cartoons, celebrity spokespeople, or actors to play satisfied patients. At the end of the advertisement is a list of risks of taking that medicine, including death. The balance between benefits and risks is essential; in this marketing category, the advertisement MUST mention potentially severe risks if they also present the benefits of taking that medicine to their audience.
The third type of prescription medicine advertisement for DTC marketing is a reminder ad. Reminder ads are concise, mentioning only the medicine’s brand name, leaving out 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. Those who support marketing medicines directly to consumers state that it’s helpful because it encourages people to talk to their physician about a health concern they may have. DTC advertising can also help remove the stigma of a particular disease or condition, such as depression or erectile dysfunction.
Opponents of DTC advertising are concerned that it promotes increased use or 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 new medicines’ risks, like serious side effects. Marketers want their product presented in the best possible light, and false or misleading claims can slip in.
In contrast, the FTC advertising rules do not require that a manufacturer mention any side effects when marketing a non-prescription medication to the public. There is continuing concern about this lack of balance, especially when a prescription medicine gets approval to move from prescription-only access to 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 from it magically disappear. 
The only type of marketing that insists a manufacturer mention the risks of taking a particular medicine is a product promotion advertisement of a prescription-only medicine. Manufacturers are not required to include their medication’s side effects in any reminder ads, help-seeking ads, or OTC medicine advertisements.
Dr. Louise Achey, Doctor of Pharmacy, is a 40-year veteran of pharmacology and author of Why Dogs Can’t Eat Chocolate: How Medicines Work and How YOU Can Take Them Safely. Check out her NEW website for daily tips on how to take your medicine safely. ®2021 Louise Achey


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