Prescription Drug Print Advertisements

Clearance at last! It only took a month of negotiation, but I can finally put my thoughts on the world wide web. Now, please grab some popcorn while I attempt to entertain you for the next 2 minutes and 14 seconds:

Fellow pharm animals,

Remember pharmacy law? Let’s kick it up a notch. With all these acts and regulations, who can keep up? That’s right. We do. As part of the Regulatory Affairs – Advertising and Promotion division of a large healthcare company in the midwest, we make sure that all promotional materials going out to you (the consumers) and to you (the healthcare professionals) are marketed safely and accurately. This means that ads adequately convey the drug’s labeled indications and do not contain misleading information.

Let’s start with an example of a well-designed print advertisement about the fictional drug, Arbitraer (Source: FDA DDMAC website):

What makes this a good ad?

1. Correctly identifies brand (Arbitraer) and generic (misvastatium) names
2. Accurately claims an FDA-approved indication
3. Appropriately states Arbitraer is given by prescription only
4. Provides “fair balance” about risks and benefits
5. The man on the beach is in the approved age range of the drug
6. Encourages reporting of adverse events to FDA
7. Refers reader to the “Brief Summary” of FDA-approved prescribing information
8. Tells readers to refer to their doctors to discourage self-diagnosis
9. Provides additional sources of drug information

What a beautiful print ad! Here’s an ugly ad of the same drug:

Problems:

1. Cannot use images of children if not approved for this age range
2. This is a false claim that is not supported by well-designed studies
3. Arbitraer is approved for seasonal nasal allergy symptoms, not asthma. Cannot make a claim that it will control asthma symptoms
4. As stated above, claims must be supported by well-designed studies
5. Risk information is in small type size and positioned far away from the benefits. “Fair balance” requirement not met.
6. No “brief summary” about risk information, and no information about reporting adverse events to Medwatch.

In a nutshell, the team I’m working with collaborates with marketing teams to keep all materials in line with the FDA rules and regulations. That’s nice, Eric. What if I don’t want to follow the rules? That’s fine…if you want to get slapped with a Notice of Violation or Warning Letter from the FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC; pronounced dee-dee-mak). More on those in the next post. Baby steps, my friend.

Eric Zhao

I am currently a summer intern in the Regulatory Affairs Department, and the opinions and positions expressed are my own and don’t necessarily reflect those of Abbott Laboratories.