Overview

A drug is "prescription only" when medical professionals must supervise its use because patients are not able to use the drug safely on their own. Because of this, Congress laid out different requirements for prescription and non-prescription or "over-the-counter" drugs. Congress also gave the Food and Drug Administration (FDA) authority to oversee prescription drug ads. In turn, the FDA passed regulations detailing how it would enforce those requirements. These regulations are also known as "rules." However, while the FDA oversees ads for prescription drugs, the Federal Trade Commission (FTC) oversees ads for over-the-counter (non-prescription) drugs.

Product Claim Advertisements

Product claim ads are the only type of ads that name a drug and discuss its benefits and risks. However, these ads must not be false or misleading in any way. We encourage companies to use understandable language throughout product claim ads that are directed to consumers.

All product claim ads, regardless of the media in which they appear, must include certain key components within the main part of the ad:

The name of the drug (brand and generic)

At least one FDA-approved use for the drug

The most significant risks of the drug

Product claim ads must present the benefits and risks of a prescription drug in a balanced fashion.

Print product claim ads also must include a "brief summary" about the drug that generally includes all the risks listed in its approved prescribing information.

Under the Food and Drug Administration Amendments Act of 2007, print advertisements need to include the following statement: "You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088."

Broadcast product claim ads (TV, radio, telephone) must include the following:

The drug's most important risks ("major statement") presented in the audio (that is, spoken) AND

Either all the risks listed in the drug's prescribing information or a variety of sources for viewers to find the prescribing information for the drug

This means that drug companies do not have to include all of a drug's risk information in a broadcast ad. Instead, the ad may tell where viewers or listeners can find more information about the drug in the FDA-approved prescribing information. This is called the "adequate provision" requirement. For broadcast ads, we have said that including a variety of sources of prescribing information fulfills this requirement.

We have suggested that broadcast ads give the following sources for finding a drug's prescribing information:

A healthcare provider (for example, a doctor)

A toll-free telephone number

The current issue of a magazine that contains a print ad

A website address

Reminder Advertisements

Reminder ads give the name of a drug, but not the drug's uses. These ads assume that the audience already knows the drug's use.

A reminder ad does not have to contain risk information about the drug because the ad does not say what the drug does or how well it works. Unlike product claim ads, reminder ads cannot suggest, in either words or pictures, anything about the drug's benefits or risks. For example, a reminder ad for a drug that helps treat asthma should not include a drawing of a pair of lungs, because this implies what the drug does.

Reminder ads are not allowed for certain prescription drugs with serious risks. Drugs with serious risks have a special warning, often called a "boxed warning," in the drug's FDA-approved prescribing information. Because of their seriousness, the risks must be included in all ads for these drugs.

Help-Seeking Advertisements

Help-seeking ads describe a disease or condition but do not recommend or suggest a specific drug treatment. Some examples of diseases or conditions discussed in help-seeking ads include allergies, asthma, erectile dysfunction, high cholesterol, and osteoporosis. The ads encourage people with these symptoms to talk to their doctor. Help-seeking ads may include a drug company's name and may also provide a telephone number to call for more information.

When done properly, help-seeking ads are not considered to be drug ads. Therefore, we do not regulate true help-seeking ads, but the FTC does regulate them. If an ad recommends or suggests the use of a specific drug, however, it is considered a product claim ad that must comply with FDA rules.

Other Product Claim Promotional Materials

Other types of promotional materials than advertisements are used to promote the use of a drug. These are called "promotional labeling" and include brochures, materials mailed to consumers, and other types of materials given out by drug companies. If these materials mention the drug's benefit(s) they must also include the drug's prescribing information.

Risk Disclosure Requirements for Different Types of Advertisements

Different advertisements require different amounts of benefit and risk information.

Reminder ads do not have to include any risk information because they cannot include any claims or pictures about what a drug does or how it works. Reminder ads are only for drugs without certain specified serious risks.

Print product claim ads may make statements about a drug's benefit(s). They must present the drug's most important risks in the main part of the ad ("fair balance"). These ads generally must include every risk, but can present the less important risks in the detailed information known as the "brief summary."

Also, print product claim and reminder ads must include the following statement:

"You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088."

Broadcast product claim ads may make statements about a drug's benefit(s). They must include the drug's most important risk information ("major statement") in a way that is clear, conspicuous, and neutral. In addition, they must include either every risk or provide enough sources for the audience to obtain the drug's prescribing information ("adequate provision").





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Note: This website does not purport to set forth all the ways in which an ad may violate the law, but rather to explain to the public some of the basic concepts related to drug advertising.

This site was developed as a collaborative effort between FDA and EthicAd to educate consumers about DTC prescription drug advertisements.