Anyone else tired of drug ads on TV?

Prescription drug ads can mislead viewers about potential health risks. Read More » 

In response to November's opinion article, BEACON reader Ken Burrows shares his take on TV drug ads:

I’m sure Raymond Reid spoke for many of us in his exasperation over the “endless barrage of drug ads on TV,” as he described in November’s BEACON. But there is a dirty little secret surrounding these ads that he didn’t mention—virtually every one of these ads is in violation of a rule governing such advertising, a rule originally proposed by the Food and Drug Administration (FDA) in March 2010.

That pivotal rule states that direct-to-consumer prescription drug ads must disclose, in what’s called a “major statement,” the product’s primary adverse effects and contradictions. More importantly, this major statement must be presented “in a clear, conspicuous and neutral manner.” 

What does this mean? Here are the key specifics:

The information must be presented in consumer-friendly language and terminology that is readily understandable.

The audio information in the major statement must be at least as understandable as the audio information in the rest of the ad.

For TV ads, the information presented in the audio portion of the major statement must also be provided concurrently in text for a sufficient duration to allow it to be read easily.

The ad must not include audio or visual elements during the presentation of the major statement that are likely to interfere with the comprehension of the major statement.

How many times do you see all manner of visual elements—usually happy, carefree “patients” fully enjoying some favorite pastime—while the adverse effects and contradictions of the advertised drug are being rapidly rattled off in voiceover? Almost every time. 

How many times are the warnings provided in text that is easily readable and not accompanied by distracting visuals? Almost never.

These types of ads have technically been in violation of the FDA rule for 14 years, but the FDA has not cracked down on the drug companies. However, in late 2023, the FDA did issue a “final rule” about the disclosure of risk information in TV and radio direct-to-consumer ads for prescription drugs. That final rule took effect in May 2024. Now, it is up to the FDA to enforce it. 

Drugmakers are expected to push back on the rule. It will be interesting to watch what happens, especially as new overseers of the FDA take up their positions in the new administration in 2025.