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
The FDA approved label is the official description of a drug product which includes indication (what the drug is used for); who should take it; adverse events (side effects); instructions for uses in pregnancy, children, and other populations; and safety information for the patient. Labels are often found inside drug product packaging, hence "package insert."
The Package Inset includes the most complete information about a prescription drug. It includes technical information about the chemistry of the drug, its proper use overall and in specific types of patients, and details about possible side effects. It is written for healthcare providers. When FDA approves a drug for marketing, it also approves the prescribing information/package insert.
Patient Opinion Leaders are patients who have an influence over other patients, especially in online venues such as social media.
The pharmaceutical industry has a long tradition of working with individual patients and patient organizations. Sometimes the goal is to promote a specific product, but more often the goal is to raise awareness about a disease or medical condition for which the company has a specific Rx treatment.
Pharma companies have hired patients as spokespeople (see "Behrman Wasn't the First Patient Spokesperson Paid Big Bucks By BMS"), given grants to patient advocacy groups (see "Pharma Dollars (Pounds, Euros) are Grassroots Seeds"), recruited individual patients to participate in market research focus groups (see "Levitra Market Research: The Interview"), and now may be hiring individual patients to monitor, moderate, or participate in online patient forums (see "J&J Agents Trolling for Adverse Events on the Internet").
In a "pay-for-delay" agreement between a brand-name drug manufacturer and a potential generic competitor, a patent holder (the brand-name manufacturer) agrees to pay a large sum of money to an accused infringer (its would-be competitor), and the competitor agrees that it will no longer challenge the patent and will not enter the market for a specified period of time.Source: Petition for a Writ of Certiorari
Brand-name pharmaceutical companies can delay generic competition that lowers prices by agreeing to pay a generic competitor to hold its competing product off the market for a certain period of time. These so-called "pay-for-delay" agreements have arisen as part of patent litigation settlement agreements between brand-name and generic pharmaceutical companies.
Pay-for-delay agreements appear in some settlements of patent litigation between brand-name and generic pharmaceutical companies. That patent litigation usually takes place within the framework for generic entry established by the Hatch-Waxman Act.
Under that Act, a generic competitor may seek entry prior to expiration of the patents on a brand-name drug. Generic drug entry before patent expiration can save consumers billions of dollars. Generics have an incentive to challenge brand patents because the first generic to file its application can obtain 180 days of marketing exclusivity during which it is the only generic on the market. To seek FDA approval for entry before patent expiration, a generic must declare that its product does not infringe the relevant patents or that the relevant patents are invalid. Typically, brand-name pharmaceutical companies challenge the generic's declaration, and litigation ensues between the brand-name and generic pharmaceutical manufacturers to determine whether the relevant patents are valid and infringed. For the brand to prevail and block entry, it must successfully defend the validity of its patents and demonstrate that the generic's product would infringe those patents. In 2002, the FTC issued a study showing that generics prevailed in 73% of the patent litigation ultimately resolved by a court decision between 1992 and June 2002.
Given the costs and potential uncertainty of patent litigation, brand-name and generic pharmaceutical companies sometimes settle their patent litigation before a final court decision. For example, the parties may agree that the generic can enter at some time before the patent's expiration date, but not as soon as the generic seeks through its litigation
A PDE (Primary Detail Equivalent) refers to one Primary Detail or two Secondary Details (details that are in the second position and receive the second most emphasis or focus), or three Tertiary Details (details that are in the third position and receive the third most emphasis or focus).
Number of days from first dose until patient stops taking drug.
A Primary Detail is a Detail that is in the first position (i. e. , no other product receives more emphasis or focus) in a sales call by a pharmaceutical sales representative.
Primary Detail means a Detail during which one of the Products is the most prominent item presented in the Call and comprises, on the average, approximately two-thirds (67%) of the time and cost of the Call. NOTE: Percentage of sales call may vary depending upon total number of details presented.
"Product Hopping" is a tactic by which brand name pharmaceutical companies can try to obstruct generic competitors and preserve monopoly profits on a patented drug by making modest reformulations that offer little or no therapeutic advantages. Prior to facing generic competition, a brand drug company can, for example, simply withdraw its original product, forcing consumers to switch to the reformulated brand drug and enabling the branded company to keep its market exclusivity and preventing consumers from obtaining the benefits of generic competition.
This "product-hop" may succeed despite the fact that consumers would not likely choose the new product. As the FTC states: "In the pharmaceutical industry â€¦ the success of a product-switching scheme does not depend on whether consumers prefer the reformulated version of the product over the original, or whether the reformulated version provides any medical benefit."
"Brochures, booklets, mailing pieces, detailing pieces, file cards, bulletins, calendars, price lists, catalogs, house organs, letters, motion picture films, film strips, lantern slides, sound recordings, exhibits, literature, and reprints and similar pieces of printed, audio or visual matter descriptive of a drug and references published (for example, the Physician's Desk Reference) for use by medical practitioners, pharmacists, or nurses, containing drug information supplied by the manufacturer, packer, or distributor of the drug and which are disseminated by or on behalf of its manufacturer, packer, or distributor are hereby determined to be labeling as defined in section 201(m) of the FD&C Act."
Source: Federal Food, Drug, and Cosmetic Act (FDCA).
The Product Labeling includes the most complete information about a prescription drug. It includes technical information about the chemistry of the drug, its proper use overall and in specific types of patients, and details about possible side effects. It is written for healthcare providers. When FDA approves a drug for marketing, it also approves the prescribing Product Labeling.
"Product-claim" ads are those ads which generally include both the name of a product and its use, or make a claim or representation about a prescription drug. Claims of drug benefits, such as safety and effectiveness, must be balanced with relevant disclosures of risks and limitations of efficacy. This balanced presentation of drug therapy is commonly referred to as "fair balance." In addition, when used in print ads, sponsors must provide a brief summary of risk information included in the product's FDA-approved labeling or, for broadcast "product-claim" ads, provide convenient access to the approved labeling. In FDA regulations, the phrase "adequate provision" is used to identify the convenient access option.