A list of terms used on this website.
An alternative way for drug companies to provide risk information about a drug in a broadcast ad. Drug companies generally must include all of a drug's risk information in a product claim ad. In print ads, they usually do this in the "brief summary." This brief summary would take many minutes to read or scroll down a TV screen. The law allows broadcast ads to include only the most important risk information if the ads tell viewers or listeners how to get the full FDA-approved prescribing information, which has all the drug's risks. To meet the "adequate provision" requirement, the broadcast ad must provide ways to find the drug's FDA-approved prescribing information.
Broadcast ads can meet the "adequate provision" requirement by giving a number of sources for finding a drug's prescribing information. These include:
- A healthcare provider (for example, a doctor)
- A toll-free telephone number
- The current issue of a magazine that contains a print ad
- A Web site address
Federal law treats advertisements and promotional labeling differently. Advertisements generally appear in:
- Print periodicals, such as journals, magazines, and newspapers
- Broadcast media, such as television and radio, as well as through telephone systems
Advertising and Promotional Labeling Branch (APLB)
The APLB is the group within the Center for Biologics Evaluation and Research (CBER) that regulates the promotion of biological products, including vaccines, tissues, and blood-related products, including allergenics, and cellular and gene therapy. For information about CBER's enforcement activities, visit their Web site.
A benefit is help provided by a drug for the person who is taking it. For example, the benefit of a drug used to treat cholesterol is that it lowers the levels of bad cholesterol (low-density lipoprotein, or LDL, cholesterol). A drug could also raise the levels of good cholesterol (high-density lipoprotein, or HDL, cholesterol). This is another possible benefit. The law does not allow drug companies to advertise benefits unless they are related to the FDA-approved use. Also, advertised benefits must be supported by "substantial evidence" or substantial clinical experience. However, healthcare providers can prescribe a drug for uses other than its FDA-approved use.
Drugs that have special problems, particularly ones that may lead to death or serious injury, may have this warning information displayed within a box in the prescribing information. This is often referred to as a "boxed" or "black box" warning. Drugs that have such boxed warnings are not permitted to have reminder ads.
A drug's common name, which is the generally advertised name. Drugs that have the same underlying active substance may be made by different companies and can have different brand names.
This is the technical name for the detailed information that appears in ads for prescription drugs. The law requires that print ads making claims about a drug (product claim ads) include a "brief summary" with all the risks listed in the drug's "prescribing information" and at least one FDA-approved use of the drug. The brief summary generally includes:
- Who should not take the drug
- When the drug should not be taken
- Possible serious side effects of the drug and, if known, what can be done to lower the chance of having them
- Frequently occurring, but not necessarily serious, side effects
The "brief summary" includes a lot of information, so it is usually presented on its own page of a print ad. When the "brief summary" is part of an ad directed at the consumer, the FDA encourages drug companies to use language consumers can easily understand.
A claim says something about the advertised drug or what it does. Claims usually relate to benefits. Claims can be made directly by stating, for example, "Brand X treats heartburn." Claims also can be made indirectly by the use of pictures or other graphics. For example, an ad with a picture of a playground full of children may suggest a claim that the advertised drug treats children.
The law says that ads for prescription drugs can only make claims that are consistent with the drug's "prescribing information." Further, the truthfulness of claims must be supported by "substantial evidence" or substantial clinical experience.
Direct-to-Consumer (DTC) Advertisements
DTC ads are published in magazines and newspapers that are distributed to a general audience rather than to healthcare providers such as doctors, nurses, and pharmacists. DTC ads can also be broadcast through television or radio. Other types of materials, such as brochures, booklets, or pamphlets distributed to patients, caregivers, or other non-healthcare providers are considered DTC promotions. While many people would think these are ads, they are technically considered a different category, called promotional labeling.
The law requires that product claim ads give a "fair balance" of information about drug risks as compared with information about drug benefits. This means that the content and presentation of a drug's most important risks must be reasonably similar to the content and presentation of its benefits.
This does not mean that equal space must be given to risks and benefits in print ads, or equal time to risks and benefits in broadcast ads. The amount of time or space needed to present risk information will depend on the drug's risks and the way that both the benefits and risks are presented.
A drug's generic name is one that a non-government organization assigns to the drug's active ingredient. Different "brand names" can be used for the same generic name ingredient. For example, the active ingredient in Synthroid® is levothyroxine. Levothyroxine is also the active ingredient in Levoxyl®. Levothyroxine is the generic name for both of the brand names Synthroid® and Levoxyl®.
Drugs sometimes interact with other drugs (prescription and non-prescription), supplements, foods, or beverages. These interactions may affect how the drug works, or may cause side effects. To avoid problems, a person thinking about taking a drug should know its possible interactions. They should also tell their healthcare provider about all the drugs and supplements they take.
The "major statement" is a term that is relevant only to broadcast (TV or radio) ads for prescription drugs. It refers to the presentation of the drug's most important risks. This presentation must be spoken. It also can be included in the video part of TV advertisements.
The amount and type of included risk information will vary by drug because different drugs have different risks.
Office of Prescription Drug Promotion (OPDP)
OPDP regulates the promotion of prescription drugs within the FDA's Center for Drug Evaluation and Research (CDER). You can learn more about OPDP from their website.
Prescribing information is also called product information, product labeling, or the package insert ("the PI"). It is generally drafted by the drug company and approved by the FDA. This information travels with a drug as it moves from the company to the pharmacist. It includes the details and directions healthcare providers need to prescribe the drug properly. It is also the basis for how the drug company can advertise its drug.
The prescribing information includes such details about the drug as:
- Its chemical description
- How it works
- How it interacts with other drugs, supplements, foods, and beverages
- What condition(s) or disease(s) it treats
- Who should not use the drug
- Serious side effects, even if they occur rarely
- Commonly occurring side effects, even if they are not serious
- Effects on specific groups of patients, such as children, pregnant women, or older adults and how to use it in these populations
Sometimes, manufacturers draft prescription drug information designed for patients that the FDA approves. These are often called "Patient Package Inserts," "Patient Product Information," or "PPIs." When the information is for an especially risky or difficult to use drug, it is called a Medication Guide. Patients should be given this information when they fill their prescription. Patients may also get information that is produced independently of the FDA and the drug company.
Promotional labeling and advertising are both used to help sell prescription drugs. Promotional labeling differs from advertising in the way it is distributed. Ads are usually broadcast on TV or radio, or are published in newspapers or magazines. Promotional labeling includes additional types of materials and ways to get them to the consumer, for example:
- Brochures and booklets
- Mailed materials, including letters to patients
- Refrigerator magnets, cups, and other giveaways that show a drug's name
Promotional labeling about a drug is said to "accompany" that drug, even if the promotional labeling is not physically attached to a drug container. Promotional labeling must be accompanied by the drug's prescribing information.
The risks of a drug refer to what can go wrong when the drug is used. A drug's prescribing information states these risks, which can include:
- What groups of patients should not use the drug because it may do them more harm than good
- When the drug should not be used
- Serious side effects
- Side effects seen in special populations, such as children, pregnant women, or older patients
- Commonly occurring side effects
- The chance of the drug causing abuse or dependence
- The chance of the drug causing withdrawal effects
Substantial Evidence (Substantiation)
Substantial evidence refers to the data needed to support claims about an advertised drug. Before the FDA approves a drug for marketing, drug companies must complete studies to show that the drug does what they say it does. These studies are also required to support advertising claims about the drug. Drug companies need to have at least two studies to support these claims.
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.