Prescription Drug Advertisements: A Tutorial

By: John Jordan, CIS Associate
johnjordan@cis-partners.com

Prescription (Rx) drug advertisements can provide useful information for consumers, as they work with their health care providers to make wise decisions about treatment. But it is important for pharmaceutical manufacturers to know that there are different types of drug advertisements, which are evaluated differently by the FDA. Some examples of Rx drug advertisements are:

1. Product Claim Ads, which name a drug, the condition it treats, and talk about both its benefits and risks;
2. Reminder Ads, which name a drug, but do not discuss its use; and
3. Help-Seeking Ads, which describe a disease or condition, but do not recommend specific drugs for treatment.

Product Claim Ads are required to provide the name of the drug (brand and generic), at least one FDA-approved use for the drug, and the most significant risks associated with the drug. The benefits and risks of the drug should be provided in equal fashion. For example, the font used for the benefits of taking the drug should not be bigger than the font used for the side effects. Information about the drug in the ad must be from well-designed studies that are FDA approved; any other information is misleading, and is a violation of FDA guidelines.

Reminder Ads assume that the audience already knows what the product is for. These ads give the viewer no knowledge of risks or benefits. Anything in the ad that could be used to remind the viewer what the drug is used for is not allowed. These types of ads cannot be used for certain Rx drugs that are associated with serious health risks. Drugs that can cause serious risks must include special warnings, called “boxed warnings,” in their FDA-approved prescribing information. Because of their seriousness, the risks associated with these drugs must be highlighted in all ads for them.

Help-Seeking Ads describe the symptoms of a disease or condition, and encourage people experiencing those symptoms to ask their doctors about the advertised Rx drug designed to treat them. These ads can include the company’s name, and usually provide a way to contact the company for more information. The FDA does not consider help-seeking ads to be official drug ads, and does not regulate them; however they are still regulated by the Federal Trade Commission (FTC).

The FDA takes action against any manufacturer whose ads violate the laws that regulate prescription drug advertising. The simplest and most common way for the FDA to take action is to send a warning letter to the manufacturer. The letter explains how the ad has violated the law, and generally asks the manufacturer to withdraw the ad. In some cases (like marketing for Yaz) the FDA will ask the drug company to fix the misimpression made by the violating ad, by publishing a corrective ad. The FDA is most likely to take this action when the misimpression poses a serious threat to public health. Sometimes the FDA takes additional enforcement action, which can include taking drug companies to court, bringing criminal charges against them, asking for an injunction (a court-enforced ban of specific activities), and even seizing supplies of the drug being advertised.

For more information on the various types of Rx drug advertisements, please see “What You Should Know about Prescription Drug Advertisements” on the FDA’s website:
http://www.fda.gov/cder/ethicad/index.htm
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