Grab Drug Advertisements By The Pills: Let The FDA Help You

Grab Drug Advertisements by the Pills: Part Two

Carrying on with the Grab Drug Advertisements by the Pills series, let’s talk about drug advertisements and the FDA. Specifically, what drug advertisements are and are not required to tell us.

Since 1962, the U.S. Food and Drug Administration (or, the FDA) has regulated prescription drug advertising under the Federal Food, Drug, and Cosmetic Act and related regulations. (The FDA considers an “advertisement” to be broadcast promotions such as television and radio, print materials such as magazines and newspapers, and even telephone contacts.)

These references cover a lot of material, so I’ll sum up what’s relevant to this series.

Prescription drug advertisements are required to:

• Explain the benefits of the medication, but they can’t make promises – especially when it comes to benefits that don’t have the evidence from testing to be backed up.
• Explain who should not take the medication. A good example of this is when you watch a commercial for an SSRI antidepressant and you’re told – during the commercial – that “people taking MAOIs shouldn’t take” whatever the SSRI antidepressant is.
• Give a statement about the side effects (if it’s a broadcast – radio or television – advertisement) and give a complete list of side effects, a Web site address, and a contact number (if it’s a print – magazine or newspaper – advertisement).

Prescription drug advertisements are not required to:

• Let you know about trials that didn’t go so well. They only have to make sure that the information they provide is an accurate representation of the “average” success rate.
• Tell you how well the medication works; only that it may work. This is tricky because while a particular drug may improve your symptoms, it may improve them only slightly. Drug advertisements don’t have to tell you that you may be looking at only a slight improvement.
• Point out alternative treatment or management options, nor do they have to remind you that there are less expensive and more beneficial treatments out there.

If a drug advertisement doesn’t comply to these requirements, the FDA will usually send an untitled letter or warning letter (two different things and sent based on the level of noncompliance) to the drug company. You can see archived copies of such letters online. (Just glancing at the examples, I saw letters to the makers of Cymbalta, Effexor XR, Rozerem, Seroquel, Zoloft, and Topamax.) Of course, other more serious enforcement actions exist, too.

The short of it is that the FDA is working hard to help protect us – the patients. Of course, that’s no reason to get lazy. Remember, the goal of this Mental Health Notes series during Patient Safety Awareness Week is to help you get more involved in your own health care by better understanding prescription drug advertisements. Let the FDA help you do just that. Become familiar with the Web site, and don’t be afraid to contact them if you need some help.

Other helpful Web pages to check out (and those that helped me with this part of the series) include:

• Direct to You: TV Drug Ads That Make Sense
• Prescription Drug Advertising and Promotional Labeling
• Promotional Material Review Process
• DDMAC’s Laws, Regulations, Guidances, and Enforcement Actions

The above image is a creation from Aaron Escobar of Escobar Studios.