Adequate Provision 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.

Adherence Percent of doses of a drug taken as prescribed for entire period of study (compliance + persistence); to combine the proper self-administration of treatment with a patient's sticking with it.

Adverse Event (AE) The definition of "adverse event" for both prescription drugs and dietary supplements is "any health-related event associated with the use of a that is adverse". This could include any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease, and, more seriously, death.

Adverse Event Report (AER) - FDA requires manufacturers, packers, and distributors of marketed prescription drug products to establish and maintain records and make reports to FDA of all serious, unexpected adverse drug experiences associated with the use of their drug products. Pharma companies must also develop written procedures for the surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences to FDA.

Awareness - Relating to a stage in a patient's behaviorial progression with regard to a medical condition in which the patient is just finding out about the condition and whether it pertains to him or her.

Biosimilar - The term biosimilar refers to biologic products that are marketed after expiration of patents, which are claimed to have similar properties to existing biologic products. Due to the complexity of biologics, a product can only be made that is similar, but not identical.

Bookend Ad - 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.

Brand, Brand Marketing - 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.

Brief Summary - In a prescription drug ad, a true statement of information relating to the side effects, contraindications, and effectiveness of the drug. .Required by the Federal Food, Drug, and Cosmetic Act (FDCA).

Compliance - Percent of doses of a drug taken as prescribed while patient is actively taking drug.

Complete Response Letter - Under new regulations that govern the drug approval process, FDA's Center for Drug Evaluation and Research (CDER) will no longer issue "approvable" or "not approvable" letters when a drug application is not approved. Instead, CDER will issue a "complete response" letter at the end of the review period to let a drug company know of the agency's decision on the application.

Continuing Medical Eduaction (CME) - A broad definition of CME recognizes that all continuing educational activities which assist physicians in carrying out their professional responsibilities more effectively and efficiently are CME. A course in management would be appropriate CME for physicians responsible for managing a health care facility; a course in educational methodology would be appropriate CME for physicians teaching in a medical school; a course in practice management would be appropriate CME for practitioners interested in providing better service to patients.

Detail Aid The detail aid -- also known as a sales aid or visual aid -- is a print piece (booklet or brochure) or an electronic document containing product information. The detail aid is used by pharmaceutical sales representatives -- or in eDetailing programs -- to engage physicians in a productive dialog about a drug.

Detailing Detailing refers to the activity of pharmaceutical sales representatives (reps) when they make calls to physicians and provide them with "details" -- approved scientific information, benefits, side effects, or adverse events -- related to a drug. Pharmasales reps were once called "detail men." These days, however, sales reps are as likely to be women as men.

Direct-to-Consumer (DTC) The promotion of prescription drugs by pharmaceutical companies directly to consumers via broadcast and print media such as television, radio, magazines, billboards, and also the Internet.

Direct Marketing Direct marketing is broadly defined by the Direct Marketing Association as "any direct communication to a consumer or business recipient that is designed to generate a response in the form of an order (direct order), a request for further information (lead generation), and/or visit to a store or other place of business for purchase of a specific product or service (traffic generation)." Direct marketing differs from traditional brand marketing in that the goal of the latter is to build awareness and affect attitude, whereas the goal of direct marketing is to achieve two-way dialogue with the prospect and affect behavior.

Disease Awareness Ad According to the FDA, disease awareness communications are communications disseminated to consumers or health care practitioners that discuss a particular disease or health condition, but do not mention any specific drug or device or make any representation or suggestion concerning a particular drug or device. Help-seeking communications are disease awareness communications directed ato consumers.

Disease Mongering Disease mongering is a term that was coined by the late journalist Lynn Payer to describe what she saw as the confluence of interests by some doctors, drug companies, patient advocacy groups and media in exaggerating the severity of illness and the ability of drugs to "cure" them.

Drug Sample According to the Prescription Drug Marketing Act of 1987, the term "drug sample" means a unit of a drug, which is not intended to be sold and is intended to promote the sale of the drug. According to this act, the manufacturer or distributor of a drug subject may distribute drug samples by mail or common carrier to practitioners licensed to prescribe such drugs or, at the request of a licensed practitioner, to pharmacies of hospitals or other health care entities. The recipient of the drug sample must execute a written receipt for the drug sample upon its delivery and the return of the receipt to the manufacturer or distributor.

eDetailing eDetailing is often used as a blanket term for various online physician marketing, promotional and communication activities. Verispan, a company that audits pharmaceutical promotional activities, identifies four primary types of physician "ePromotion" activities, a few of which may be considered eDetailing:

ePrescribing ePrescribing is the ability of a physician to submit a "clean" prescription directly to a pharmacy from the point of care.

eSampling Electronic Sampling uses online tools/promotinal websites accessed by physicians to collect the details of sample distribution. It provides pharmaceutical companies with a cost-effective way to reach physicians who have been routinely under-covered by sales representatives.It allows manufacturers to meet increasingly challenging sales and marketing goals by reducing the significant costs associated with the traditional sample distribution process.

Fair Balance In direct-to-consumer advertising, fair balance refers to the presentation of accurate and fair assessment of the risks as well as the benefits of the drug.

(FDA) Guidance FDA "guidance" represents the current thinking of the Food and Drug Administration on a topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An FDA regulation, on the other hand, carries the weight of law.FDA issues guidance documents -- ie, publishes them in the Federal Register -- usualy after doing research, which can include holding public hearings.

Help-Seeking Ad Help-seeking ads are communications disseminated to consumers or health care practitioners that discuss a particular disease or health condition, but do not mention any specific drug or device or make any representation or suggestion concerning a particular drug or device. These communications are not subject to the disclosure requirements of the Federal Food, Drug, and Cosmetics Act and FDA regulations.

Investigational New Drug (IND) The process of getting a drug approved by the FDA -- the investigational new drug ("IND") process -- is costly and time-consuming. The IND process typically has three separate phases.

1. "Phase I" trials, evaluate the safety of the medication by studying the effect of the drug and are designed to determine the metabolic and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness.
2. "Phase II" trials are designed to obtain preliminary data on the effectiveness of the drug for a particular indication or indications in patients with the disease or condition.
3. "Phase III" trials, are intended to gather additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug.

Many drugs, like chemotherapy for an example, have deeply deleterious -- sometimes even fatal -- side effects, and part of the FDA approval process is weighing the potentiality for those side effects against the disease process the drug is designed to treat. The sponsor's goal at the end of the IND process is an approved New Drug Application ("NDA").

Key Opinion Leader Key Opinion Leaders are physicians who influence their peers' medical practice, including but not limited to prescribing behavior.

Labeling Description of a drug and references published (for example, the Physician's Desk Reference) for use by medical practitioners.

Multichannel Marketing (MCM) Multichannel pharma marketing refers to the use of multiple synchronized communication channels to reach consumers, patients, and physicians with marketing communications or information at the appropriate point in their decision cycles.

Medical Science Liaison (MSL) Professionals (employees of pharmaceutical companies) -- most with advanced medical, pharmacy or science degrees -- that offer credibility and objectivity of a peer, but also provide an insider's knowledge of their companies and products. MSLs coordinate the flow of clinical information and manage important key opinion leader (KOL) relationships, which can be critical to a product's success at any stage of its life cycle.

New Drug Application (NDA) When the sponsor of a new drug believes that enough evidence on the drug's safety and effectiveness has been obtained to meet FDA's requirements for marketing approval, the sponsor submits to FDA a new drug application (NDA). The application must contain data from specific technical viewpoints for review, including chemistry, pharmacology, medical, biopharmaceutics, and statistics. If the NDA is approved, the product may be marketed in the United States. For internal tracking purposes, all NDA's are assigned an NDA number.

New Molecular Entity (NME) A New Molecular Entity (NME) or New Chemical Entity (NCE) is a drug or chemical that is without precedent among regulated and approved drug products. The NME designation indicates that a drug in development is not a version or derivative of an existing and previously investigated, trialed and approved substance. Being labeled as entirely 'new' or first-in-class molecule dictates that certain types of clinical trials must be run, and that particular attention must be paid to proving a drugs safety.

New Prescriptions (NRx) Precise measurement of pharma marketing's impact requires physician presciption (Rx) data. One metric used is the number of new prescriptions (NRx; TNew Prescriptions) written by physicians for a particular drug over a specific period of time. NRx does NOT include prescriptions for refills, but does include renewals, which are scripts patients get when they run out of refills. In contrast, TRx (Total Prescriptions) includes refills AND renewals.

Off Label An unlabeled use [off-label use] of a drug is a use that is not included as an indication on the drug's label as approved by the FDA.

Package Insert 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."

Persistence Number of days from first dose until patient stops taking drug.

Product-claim DTC Ads "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.

Relationship Marketing Use of various interactive media to develop, maintain, and foster a relationship with a current and prospective customer to maximize need satisfaction, share of mind and budget, and nurture loyalty and, ultimately, advocacy of the brand of a product or service.

Reminder Ad A reminder ad mentions the pharmaceutical brand name but not the indication or medical condition it treats.

Sales Aid The sales aid -- also known as a detail aid or visual aid -- is a print piece (booklet or brochure) or an electronic document containing product information. The sales aid is used by pharmaceutical sales representatives -- or in eDetailing programs -- to engage physicians in a productive dialog about a drug.

Sampling Sampling (ie, Drug Sampling) is the process by which pharmaceutical companies distribute free drugs (Drug Samples) to physicians. According to the Prescription Drug Marketing Act of 1987, the term "drug sample" means a unit of a drug, which is not intended to be sold and is intended to promote the sale of the drug. According to this act, the manufacturer or distributor of a drug subject may distribute drug samples by mail or common carrier to practitioners licensed to prescribe such drugs or, at the request of a licensed practitioner, to pharmacies of hospitals or other health care entities. The recipient of the drug sample must execute a written receipt for the drug sample upon its delivery and the return of the receipt to the manufacturer or distributor.

Thought Leader Physician Thought Leaders are physicians who, because of their credentials and knowledge, have influence their peers' medical practice, including but not limited to prescribing behavior.

Total Prescriptions (TRx) Precise measurement of pharma marketing's impact requires physician presciption (Rx) data. One metric used is the total number of prescriptions (TRx; Total Prescriptions) written by physicians for a particular drug over a specific period of time. This includes prescriptions for refills and renewals, which are scripts patients get when they run out of refills. In contrast, NRx (New Prescriptions) do NOT include refills but DO include renewals.

Untitled Letter An FDA Untitled Letter is an initial correspondence with regulated industry that cites violations that do not meet the threshold of a Warning Letter. Untitled Letters are intended to cover those circumstances where the Agency has a need to communicate with regulated industry about violations that do not meet the threshold of regulatory significance as described above. The three types of letters related to licensed products that are issued by CBER and CDER, pursuant to section 6.3 of these procedures, do not necessarily fall within this definition of an Untitled Letter; however, they are still Untitled Letters that are covered by the scope of these procedures.

Visual Aid The visual aid -- also known as a detail aid or sales aid -- is a print piece (booklet or brochure) or an electronic document containing product information. The visual aid is used by pharmaceutical sales representatives -- or in eDetailing programs -- to engage physicians in a productive dialog about a drug.

Warning Letter An FDA Warning Letter is a correspondence that notifies a pharmaceutical or other FDA-regulated company about violations that FDA has documented during its inspections or investigations.