Condensed definitions appear after each term.
Click on a letter below to view a list of terms beginning with that letter.
The Pharma Marketing Glossary
Source: FDA Glossary; Drug Advertising - A Glossary of Terms
A boxed warning, commonly referred to as a "black box" warning, is the most serious type of warning mandated by the U.S. Food and Drug Administration (FDA). They are prominently featured in the labeling of drugs to warn prescribers about serious adverse reactions or special problems. Boxed warnings are displayed on a drug's package insert, in the Physicians' Desk Reference, on the FDA's Web site, and on the Web sites of drug marketing companies. Physicians are required to provide patients with information about relevant risks, but they can use professional judgment to decide whether to prescribe a drug with a boxed warning.
Source: American Family Physician, FDA Boxed Warnings: How to Prescribe Drugs Safely.
Economists and physicians have thoroughly studied the effects of FDA boxed warnings on prescription patterns. It is not necessarily true that a physician and patient will have a conversation about a drug's boxed warning after it is issued.[3] For instance, an FDA-mandated boxed warning decreased rosiglitazone use by 70%, but that still meant 3.8 million people were given the drug. Later research indicated that after receiving an FDA advisory, there was a decrease in rosiglitazone use, due to a combined effect of media exposure, advisory, and scientific publications, whereas pioglitazone (with a similar advisory) did not similarly decrease in use. This challenges the idea that physicians and patients will have a conversation after a boxed warning is issued. Throughout the country, boxed warnings will be translated into prescription patterns differently by different physicians.
Source: Wikipedia, Boxed warning.
FDA has from time to time seen manufacturers use "bookend" advertisements in print or broadcast formats. These advertisements consist of two parts: (1) a "reminder" advertisement, which includes the name of a drug or device but makes no safety or effectiveness claims; and (2) a disease awareness message encouraging consumers to seek health care practitioner assistance in identifying and treating a particular health condition but does not mention any product by name. Neither component alone would be subject to FDA rules for requiring risk disclosure. But taken together, FDA is concerned that they are understood by consumers as product claim advertisements, without the inclusion of proper disclosure of required risk information.
The draft guidance therefore provides advice to manufacturers on the criteria FDA uses in determining whether bookend advertisements are subject to regulation as product claim advertisements. The criteria, in brief, are whether the two components are perceptually distinct and whether they are separated in space or time. FDA requests comment on these two criteria.
Article: "FDA Draft Guidance for Print DTCA: Less than Feared"
FDA may treat ads as labeling or advertising: "when the communication is presented in combination with reminder promotion or product claim promotion in a way that causes the audience to perceive the two pieces as one advertisement or promotional labeling piece."
"For example, some drug firms have broadcast help-seeking advertisements in combination with perceptually similar reminder advertisements, separated only by a brief period containing unrelated intervening matter. When considered in isolation, the help-seeking advertisement conveys the message, 'There is help for a particular medical condition; see your doctor,' As discussed above, this advertisement would be neither labeling nor advertising and thus would not be subject to the requirements under the act for the disclosure of risk and other information. The perceptually similar reminder advertisement, by itself, conveys the message, 'This specific product is available; see your doctor.' As discussed above, this advertisement would be exempted by regulation from the requirements for disclosure of risk or other information."
"Together, however, these two advertisements communicate information about a treatable disease or health condition and the name of a product approved for treatment of a disease or health condition, and effectively constitute an advertisement that communicates a productÂ’s indication and efficacy for a certain medical condition without providing risk and other information. If a disease awareness or help-seeking piece and a reminder advertisement are presented in a manner that causes their messages to be linked together by the audience, the failure of the combined communication to include the risk and other information required under the act and FDA regulations would cause the advertised product to be misbranded."
The American Marketing Association defines a brand as "a name, term, design, symbol, or any other feature that identifies one seller's good or service as distinct from those of other sellers." Walter Landor, who helped create and develop such famous brands as Coca-Cola, defined a brand as a "promise." "By identifying and authenticating a product or service, it delivers a pledge of satisfaction and quality."
Brand marketing focuses on communicating the brand message to drive awareness and affect attitude.
Where to find more information:- "You May Walk Like a Duck and Quack Like a Duck, But You're No Duck!,"
- "Relationship Marketing Program Management for Pharmaceutical Marketers,"
A brick-level sales data system is a way of organizing sales data on a regional basis, with a "brick" referring to a small geographical area consisting of at least four or five pharmacies. Pharmaceutical companies use brick-level data for various purposes including measuring the effectiveness of their salespeople and designing incentives schemes.
Data service companies like IMS Health and NDC organize the data into "bricks." The pharmaceutical companies, in turn, organize their sales forces and incentive programs according to that brick structure. For example, a salesperson's territory may consist of several bricks and market shares are often tracked according to bricks.
- 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. The brief summary may leave out non-risk information, such as the chemical description of the drug, how it works in the body, and directions for using it.
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