FDA Overhauls Medication Ads

FDA Overhauls Medication Ads | Pintas & Mullins Law Firm

Big Pharma knows the value of a great television commercial and how important advertisements can be in enticing the public to buy their latest drugs. In its efforts to heighten oversight and regulation, the FDA recently asked for more research to be done into how these ads could be improved, to in turn improve patient outcomes. Dangerous drug attorneys at Pintas & Mullins Law Firm hope this call for research will actually reduce the prevalence of serious and unnecessary side effects.

The FDA study is entitled “Disclosure Regarding Additional Risks in Direct-to-Consumer (DTC) Prescription Drug Televisions Advertisements,” which refers to the long-winded list of possible side effects present at the end of every medication commercials. You know the commercials I’m talking about – let’s take a more recent example, for testosterone therapy in men of certain age.

The ads usually play during sports games or other male-oriented programs, and depict a man in his 40s or 50s, with his wife, talking about his symptoms of low testosterone. Testosterone decreases in men as they age, just as estrogen decreases in women. Symptoms of this natural occurrence are different for everyone, but can include low energy, decreased libido, irritability, and changes in fat distribution.

The man in the commercial discussed his issues with his doctor, who diagnosed him with “low T.” This is where AndroGel comes in to save this man, his wife and his Ford Mustang, from the completely natural phenomenon of low T (even though AndroGel was only approved for treatment of low T in conjunction with another medical disorder). The narrator then spends about 40 seconds detailing the possible side effects of AndroGel, which are vast and extremely severe. This list, often delivered with Busta Rhymes-like rapidity, is known as the major statement.

Too Little To Late?

This is what the FDA is now attempting to fix. There have been many Saturday Night Live sketches satirizing these commercials and their laundry lists of extreme, often fatal side effects. Many believe the FDA hopes to shorten the major statement in favor of listing only the “serious and actionable” risks. It is also important to note that the agency is actively seeking our public comment on how to improve major statements. A link to comment can be found here.

The argument is that consumers become desensitized to drugs’ real dangers (such as death or heart attack) when they are cataloged between a list of a dozen more trivial side effects (such as nausea or skin irritation). According to an NPR article, the agency has been considering this type of change for years along with academics, medical experts, and Big Pharma.

Many believe that cutting back on the catalogue of information and instead referring patients to physicians for more information is the correct change. In turn, drug makers will have to make drug labels easier to read and understand. There are numerous studies that examine how people remember and track information given to them. Among their findings, researchers concluded that the order or information really does affect whether it is remembered and slower speech improved understanding.

Conversely, data by the Pharmaceutical Research and Manufacturers of America show that direct to consumer marketing does not actually work that well in conveying true risks of drugs. The group asserts that advertisements are good at one thing and one thing only: increasing drug sales. This causes not only misunderstandings about possible side effects, but also leads to overtreatment. 

Ads are designed to appeal to our emotions, which in turn makes people overestimate how beneficial the products can be in their lives. In effort to combat this, the FDA urges doctors to report bad or obviously exaggerated drug commercials and marketing materials. Experts see this as a reactive, rather than proactive solution to fraudulent promotion practices.

Our team of dangerous drug lawyers is currently investigating cases of serious injury and illness from prescription medications, such as AndroGel. If you or someone you love was hospitalized from a medication, you may be able to file an injury claim against the manufacturer. Contact our firm today with any questions about the drug you took and serious side effects suffered. Our case reviews are always free and confidential, and available to injured patients throughout the country.