A pharmaceutical company, or drug company, is a commercial business whose focus is to research, develop, market and/or distribute drugs, most commonly in the context of healthcare.^[1] They can deal in generic and/or brand medications. They are subject to a variety of laws and regulations regarding the patenting, testing and marketing of drugs. From its beginnings at the start of the 19th Century, the pharmaceutical industry is now one of the most successful and influential, attracting both praise and controversy. This article does not cite any references or sources. ... A generic drug (pl. ... For other uses, see Brand (disambiguation). ...

History

Most of today's major pharmaceutical companies were founded in the late 19th and early 20th centuries. Key discoveries of the 1920s and 1930s, such as insulin and penicillin, became mass-manufactured and distributed. Switzerland, Germany and Italy had particularly strong industries, with the UK and US following suit. Not to be confused with inulin. ... For the Japanese rock band, see Penicillin (band). ...

Legislation was enacted to test and approve drugs and to require appropriate labeling. Prescription and nonprescription drugs became legally distinguished from one another as the pharmaceutical industry matured. The industry got underway in earnest from the 1950s, due to the development of systematic scientific approaches, understanding of human biology (including DNA) and sophisticated manufacturing techniques. The structure of part of a DNA double helix Deoxyribonucleic acid, or DNA, is a nucleic acid molecule that contains the genetic instructions used in the development and functioning of all known living organisms. ...

Numerous new drugs were developed during the 1950s and mass-produced and marketed through the 1960s. These included the first oral contraceptive, “The Pill”, Cortisone, blood-pressure drugs and other heart medications. MAO Inhibitors, chlorpromazine (Thorazine), Haldol (Haloperidol) and the tranquilizers ushered in the age of psychiatric medication. Valium (diazepam), discovered in 1960, was marketed from 1963 and rapidly became the most prescribed drug in history, prior to controversy over dependency and habituation. Chlorpromazine was the first antipsychotic drug, used during the 1950s and 1960s. ... Haloperidol (Aloperidin®; Bioperidolo®; Brotopon®; Dozic®; Einalon S®; Eukystol®; Haldol®; Halosten®; Keselan®; Linton®; Peluces®; Serenace®; Serenase®; Sigaperidol®) is a conventional butyrophenone antipsychotic drug. ... Diazepam, brand names: Valium, Seduxen, in Europe Apozepam, is a 1,4-benzodiazepine derivative, which possesses anxiolytic, anticonvulsant, sedative and skeletal muscle relaxant properties. ...

Attempts were made to increase regulation and to limit financial links between pharmaceutical companies and prescribing physicians, including by the relatively new US FDA. Such calls increased in the 1960s after the thalidomide tragedy came to light, in which the use of a new tranquilizer in pregnant women caused severe birth defects. In 1964, the World Medical Association issued its Declaration of Helsinki, which set standards for clinical research and demanded that subjects give their informed consent before enrolling in an experiment. Phamaceutical companies became required to prove efficacy in clinical trials before marketing drugs. The United States Food and Drug Administration is the government agency responsible for regulating food, dietary supplements, drugs, cosmetics, medical devices, biologics and blood products in the United States. ... This article is about the drug. ... Efficacy is the ability to produce a desired amount of a desired effect. ...

Cancer drugs were a feature of the 1970s. From 1978, India took over as the primary center of pharmaceutical production without patent protection.^{[citation needed]}

The industry remained relatively small scale until the 1970s when it began to expand at a greater rate.^{[citation needed]} Legislation allowing for strong patents, to cover both the process of manufacture and the specific products, came in to force in most countries. By the mid-1980s, small biotechnology firms were struggling for survival, which led to the formation of mutually beneficial partnerships with large pharmaceutical companies and a host of corporate buyouts of the smaller firms. Pharmaceutical manufacturing became concentrated, with a few large companies holding a dominant position throughout the world and with a few companies producing medicines within each country.

The pharmaceutical industry entered the 1980s pressured by economics and a host of new regulations, both safety and environmental, but also transformed by new DNA chemistries and new technologies for analysis and computation.^{[citation needed]} Drugs for heart disease and for AIDS were a feature of the 1980s, involving challenges to regulatory bodies and a faster approval process.

Managed care and Health maintenance organizations (HMOs) spread during the 1980s as part of an effort to contain rising medical costs, and the development of preventative and maintenance medications became more important. A new business atmosphere became institutionalized in the 1990s, characterized by mergers and takeovers, and by a dramatic increase in the use of contract research organizations for clinical development and even for basic R&D. The pharmaceutical industry confronted a new business climate and new regulations, born in part from dealing with world market forces and protests by activists in developing countries. Animal Rights activism was also a problem. Managed care is a concept in U.S. health care. ... This article does not cite any references or sources. ... Animal liberation redirects here. ...

Marketing changed dramatically in the 1990s, partly because of a new consumerism.^{[citation needed]} The Internet made possible the direct purchase of medicines by drug consumers and of raw materials by drug producers, transforming the nature of business. In the US, Direct-to-consumer advertising proliferated on radio and TV because of new FDA regulations in 1997 that liberalized requirements for the presentation of risks. The new antidepressants, the SSRIs, notably Fluoxetine (Prozac), rapidly became bestsellers and marketed for additional disorders. Prozac redirects here. ...

Drug development progressed from a hit-and-miss approach to rational drug discovery in both laboratory design and natural-product surveys. Demand for nutritional supplements and so-called alternative medicines created new opportunities and increased competition in the industry. Controversies emerged around adverse effects, notably regarding Vioxx in the US, and marketing tactics. Pharmaceutical companies became increasingly accused of disease mongering or over-medicalizing personal or social problems.^[2] Rofecoxib is a nonsteroidal anti-inflammatory drug (NSAID) that was used in the treatment of osteoarthritis, acute pain conditions, and dysmenorrhoea. ... Disease mongering is a term used to describe a perceived attempt by pharmaceutical companies to promote public awareness of (frequently harmless) conditions or diseases with the aim of increasing sales of medication. ...

There are now more than 200 major pharmaceutical companies, jointly said to be more profitable than almost any other industry, and employing more political lobbyists than any other industry.^{[citation needed]} Advances in biotechnology and the human genome project promise ever more sophisticated, and possibly more individualized, medications.

Research and development

Main article: Drug discovery and Drug development In medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are discovered and/or designed. ... It has been suggested that this article or section be merged into Pharmacology. ...

Drug discovery is the process by which potential drugs are discovered or designed. In the past most drugs have been discovered either by isolating the active ingredient from traditional remedies or by serendipitous discovery. Modern Biotechnology often focuses on understanding the metabolic pathways related to a disease state or pathogen, and manipulating these pathways using molecular biology or Biochemistry. A great deal of early-stage drug discovery has traditionally been carried out by universities and research institutions. A medication is a drug or substance taken to reduce symptoms or cure an illness or medical condition. ... Look up Serendipity in Wiktionary, the free dictionary. ... The structure of insulin Biotechnology is technology based on biology, especially when used in agriculture, food science, and medicine. ... In biochemistry, a metabolic pathway is a series of chemical reactions occurring within a cell. ... This article is about the medical term. ... A pathogen or infectious agent is a biological agent that causes disease or illness to its host. ... Molecular biology is the study of biology at a molecular level. ... Biochemistry (from Greek: , bios, life and Egyptian kēme, earth[1]) is the study of the chemical processes in living organisms. ...

Drug development refers to activities undertaken after a compound is identified as a potential drug in order to establish its suitability as a medication. Objectives of drug development are to determine appropriate Formulation and Dosing, as well as to establish safety. Research in these areas generally includes a combination of in vitro studies, in vivo studies, and clinical trials. The amount of capital required for late stage development has made it a historical strength of the larger pharmaceutical companies.^{[citation needed]} Formulation ... Dosing generally applies to feeding chemicals or medicines in small quantities into a process fluid or to a living being at intervals or to atmosphere at intervals to give sufficient time for the chemical or medicine to react or show the results. ... ... In vitro (Latin: within the glass) refers to the technique of performing a given experiment in a test tube, or, generally, in a controlled environment outside a living organism. ... In vivo (Latin for (with)in the living). ... In medicine, a clinical trial (synonyms: clinical studies, research protocols, medical research) is a research study. ...

Often, large multinational corporations exhibit vertical integration, participating in a broad range of drug discovery and development, manufacturing and quality control, marketing, sales, and distribution. Smaller organizations, on the other hand, often focus on a specific aspect such as discovering drug candidates or developing formulations. Often, collaborative agreements between research organizations and large pharmaceutical companies are formed to explore the potential of new drug substances. It has been suggested that Vertical expansion be merged into this article or section. ...

The cost of innovation

Drug discovery and development is very expensive; of all compounds investigated for use in humans only a small fraction are eventually approved by the FDA. Each year, only about 25 truly novel drugs (New chemical entities) are approved for marketing. This approval comes only after heavy investment in pre-clinical development and clinical trials, as well as a commitment to ongoing safety monitoring. Drugs which fail part-way through this process often incur large costs, while generating no revenue in return. If the cost of these failed drugs is taken into account, the cost of developing a successful new drug (New chemical entity or NCE), has been estimated at about 1 billion USD^[3](not including marketing expenses). A study by the consulting firm Bain & Company reported that the cost for discovering, developing and launching (which factored in marketing and other business expenses) a new drug (along with the prospective drugs that fail) rose over a five year period to nearly $1.7 billion in 2003.^[4] Approved drugs -In the United States, the FDA approves prescription drugs. ... The United States Food and Drug Administration is the government agency responsible for regulating food, dietary supplements, drugs, cosmetics, medical devices, biologics and blood products in the United States. ... Activities that need to be performed and results to be obtained a before a clinical trial in humans can begin. ... In health care, including medicine, a clinical trial (synonyms: clinical studies, research protocols, medical research) is a process in which a medicine or other medical treatment is tested for its safety and effectiveness, often in comparison to existing treatments. ... Safety Monitoring of a clinical trial is conducted by an independent physician with relevant expertise. ... According to the U.S. Food and Drug Administration, a new chemical entity means a drug that contains no active moiety that has been approved by FDA in any other application submitted under section 505(b) of the Food, Drug and Cosmetic Act. ... Bain & Company is a management consulting firm, headquartered in Boston, MA, that is recognized as one of the leading business institutions in the world. ...

These estimates also take into account the opportunity cost of investing capital many years before revenues are realized (see Time-value of money). Because of the very long time needed for discovery, development, and approval of pharmaceuticals, these costs can accumulate to nearly half the total expense. Some approved drugs, such as those based on re-formulation of an existing active ingredient (also referred to as Line-extensions) are much less expensive to develop. The consumer advocacy group Public Citizen suggests on its web site that the actual cost is under $200 million, about 29% of which is spent on FDA-required clinical trials. For me-too-drugs and for generics, the cost are even less. Opportunity cost is a central concept of microeconomics. ... The time value of money (TVM) or the present discounted value is one of the basic concepts of finance. ... An active ingredient, also active pharmaceutical ingredient (or API), is the substance in drug that is pharmaceutically active. ...

Calculations and claims in this area are controversial because of the implications for regulation and subsidization of the industry through federally funded research grants. In economics, a subsidy is a kind of financial government assistance, such as a grant, tax break, or trade barrier, in order to encourage the production or purchase of a good. ...

Controversy about drug development and testing

There have been increasing accusations and findings that clinical trials conducted or funded by pharmaceutical companies are much more likely to report positive results for the preferred medication.^[5]

In western countries generally the law allows pharmacy companies to withhold information from research that they do not wish to disclose and the usual procedure is that several research programmes are carried out and only the most favorable ones are published.^{[citation needed]} In response to public outcry about specific cases in which unfavorable data from pharmaceutical company-sponsored research was suppressed, the Pharmaceutical Research and Manufacturers of America have published new guidelines urging companies to report all findings and limit the financial involvement in drug companies of researchers.^[6] Pharmaceutical Research and Manufacturers of America (PhRMA) is a trade group representing the pharmaceutical research and biotechnology companies in the United States. ...

Drug researchers not directly employed by pharmaceutical companies often look to companies for grants, and companies often look to researchers for studies that will make their products look favorable. Sponsored researchers are rewarded by drug companies, for example with support for their conference/symposium costs. Lecture scripts and even journal articles presented by academic researchers may actually be 'ghost-written' by pharmaceutical companies.^[7] Some researchers who have tried to reveal ethical issues with clinical trials or who tried to publish papers that show harmful effects of new drugs or cheaper alternatives have been threatened by drug companies with lawsuits.^[8][9]

Product approval in the US

Main article: Food and Drug Administration #Regulation of drugs

In the United States, new pharmaceutical products must be approved by the FDA as being both safe and effective. This process generally involves submission of an Investigational new drug filing with sufficient pre-clinical data to support proceeding with human trials. Following IND approval, three phases of progressively larger human clinical trials may be conducted. Phase I generally studies toxicity using healthy volunteers. Phase II can include Pharmacokinetics and Dosing in patients, and Phase III is a very large study of efficacy in the intended patient population. “FDA” redirects here. ... The United States Food and Drug Administration is the government agency responsible for regulating food, dietary supplements, drugs, cosmetics, medical devices, biologics and blood products in the United States. ... Ind can refer to: India, abbreviation Immigration and Nationality Directorate - UK Home Office Iota Nu Delta, fraternity Indianapolis International Airport International Nurses Day Investigational New Drug IND, ISO 639-2 code for the Indonesian language IND, the Independent Subway System, one of three of the original New York Subway systems... // Toxic and Intoxicated redirect here – toxic has other uses, which can be found at Toxicity (disambiguation); for the state of being intoxicated by alcohol see Drunkenness. ... Pharmacokinetics (in Greek: pharmacon meaning drug, and kinetikos meaning putting in motion) is a branch of pharmacology dedicated to the determination of the fate of substances administered externally to a living organism. ... Dosing generally applies to feeding chemicals or medicines in small quantities into a process fluid or to a living being at intervals or to atmosphere at intervals to give sufficient time for the chemical or medicine to react or show the results. ...

A fourth phase of post-approval surveillance is also often required due to the fact that even the largest clinical trials cannot effectively predict the prevalence of rare side-effects. Post-marketing surveillance ensures that after marketing the safety of a drug is monitored closely. In certain instances, its indication may need to be limited to particular patient groups, and in others the substance is withdrawn from the market completely.

The FDA provides information about approved drugs at the Orange Book site.^[10] In the UK, the British National Formulary is the core guide for pharmacists and clinicians. Otherwise known as the doctors prescribing Bible the British National Formulary (BNF) contains a wide spectrum of information on prescribing and pharmacology, among others indications, side effects and costs of the prescription of all medication drugs available on the National Health Service. ...

Orphan drugs

Main article: Orphan drug

There are special rules for certain rare diseases ("orphan diseases") involving fewer than 200,000 patients in the United States, or larger populations in certain circumstances. ^[11] Because medical research and development of drugs to treat such diseases is financially disadvantageous, companies that do so are rewarded with tax reductions, fee waivers, and market exclusivity on that drug for a limited time (seven years), regardless of whether the drug is protected by patents. The granting of the orphan drug status is designed to encourage the development of drugs which are necessary but would be prohibitively expensive/un-profitable to develop under normal circumstances. ... An orphan drug is any drug developed under the 1983 U.S. Orphan Drug Act, which concerns drugs for orphan diseases, namely such affecting less than 200,000 people in the US. This has been adopted as a subclause of the FDA. Developing a drug for groups that small would...

Legal issues

Where pharmaceutics have been shown to cause side-effects, civil action has occurred, especially in countries where tort payouts are likely to be large. Due to high-profile cases leading to large compensations, most pharmaceutical companies endorse tort reform. Recent controversies have involved Vioxx and SSRI antidepressants. A lawsuit is a civil action brought before a court in order to recover a right, obtain damages for an injury, obtain an injunction to prevent an injury, or obtain a declaratory judgment to prevent future legal disputes. ... Not to be confused with torte, an iced cake. ... Tort reform is the phrase used by its advocates who claim it is a change in the legal system to reduce litigations alleged adverse effects on the economy. ... Rofecoxib is a nonsteroidal anti-inflammatory drug (NSAID) that was used in the treatment of osteoarthritis, acute pain conditions, and dysmenorrhoea. ... SSRI is an acronym that stands for several things: It is a class of antidepressants called selective serotonin reuptake inhibitor SSRI also is used as the stock symbol for Silver Standard Resources Inc. ...

Patents

Depending on a number of considerations, a company may apply for and be granted a patent for the drug, or the process of producing the drug, for about 20 years. Only after rigorous study and testing, which can take as long as 12 years, will governmental authorities grant permission for the company to market and sell the drug.^{[citation needed]} A chemical patent is an important source of technical and bibliographic information. ...

Industry revenues

For the first time ever, in 2006, global spending on prescription drugs topped $600 billion, even as growth slowed somewhat in Europe and North America. Sales of prescription medicines worldwide rose 7 percent to $602 billion, according to IMS Health, a pharmaceutical information and consulting company. The United States still accounts for most, with $252 billion in annual sales. Sales there grew 5.7 percent. Emerging markets such as China, Russia, South Korea and Mexico outpaced that market, growing a huge 81 percent.^[12] This article or section contains information that has not been verified and thus might not be reliable. ...

In 2004 the U.S. comprised roughly 45% of the pharmaceutical market worldwide, while Europe comprises about 25% (AMR Research). 2004 global dollar sales reached $550 billion, a 7% increase over 2003, which in turn represented a 9% increase over 2002. 2004 US sales grew to $235.4 billion, a growth rate of 8.3% compared with 11.5% growth from 2002 to 2003.^[13] US profit growth was maintained even whilst other top industries saw slowed or no growth.^[14]

Pfizer's cholesterol pill Lipitor remains the best-selling drug in the world for the fifth year in a row. Its annual sales were $12.9 billion, more than twice as much as its closest competitors: Plavix, the blood thinner from Bristol-Myers Squibb and Sanofi-Aventis; Nexium, the heartburn pill from AstraZeneca; and Advair, the asthma inhaler from GlaxoSmithKline.^[12] Atorvastatin (INN) (IPA: ) is a member of the drug class known as statins, used for lowering cholesterol and thereby reducing cardiovascular disease. ... A box of Plavix Clopidogrel is a potent oral antiplatelet agent often used in the treatment of coronary artery disease, peripheral vascular disease, and cerebrovascular disease. ... Esomeprazole is a proton pump inhibitor used in the treatment of dyspepsia, peptic ulcer disease (PUD), GERD and Zollinger-Ellison syndrome. ... The combination preparation fluticasone/salmeterol is a formulation containing fluticasone propionate and salmeterol xinafoate used in the management of asthma and chronic obstructive pulmonary disease (COPD). ...

IMS Health publishes an analysis of trends expected in the pharmaceutical industry in 2007, including increasing profits in most sectors despite loss of some patents, and new 'blockbuster' drugs on the horizon.^[15] This article or section contains information that has not been verified and thus might not be reliable. ...

Teradata Magazine predicted that by 2007, $40 billion in U.S. sales could be lost at the top 10 pharma companies as a result of slowdown in R&D innovation and the expiry of patents on major products, with 19 blockbuster drugs losing patent.^[16]

Sales leaders

The top ten pharmaceutical companies by 2006 sales are:^[17]

NB The top 25 Pharmaceutical Company lists produced by Wood-Mackenzie for the years 2004-2006 can be found at: http://www.p-d-r.com/ranking/ranking.html on the P-D-R website. Pfizer Incorporated (NYSE: PFE) is the worlds largest research-based pharmaceutical company[1].[1] The company is based in New York City. ... GlaxoSmithKline plc (LSE: GSK NYSE: GSK) is a British based pharmaceutical, biological, and healthcare company. ... Sanofi-aventis (Euronext: SAN, NYSE: SNY), headquartered in Paris, France, is one of the 3 largest pharmaceutical companies in the world, along with Pfizer,GlaxoSmithKline. ... Novartis Suffern Yes plant is the Swiss companys sole pharmaceutical production facility in the U.S. Novartis International AG is a multinational pharmaceutical company based in Basel, Switzerland that manufactures mainstream products such as Benefiber (a fiber supplement) and Lamisil (a foot fungus medicine). ... F. Hoffmann–La Roche, Ltd. ... AstraZeneca PLC (LSE: AZN, OMX: AZN), is a large Anglo-Swedish pharmaceutical company formed on 6 April 1999 by the merger of Swedish Astra AB and British Zeneca Group PLC. Zeneca was part of Imperial Chemical Industries prior to a demerger in 1993. ... Johnson & Johnson (NYSE: JNJ) is a global American pharmaceutical, medical devices and consumer packaged goods manufacturer founded in 1886. ... Merck & Co. ... Wyeth, formerly known as American Home Products, is one of the largest pharmaceutical companies in the world. ... Eli Lilly and Company (NYSE: LLY) is a global pharmaceutical company and one of the worlds largest corporations. ...

Patents and generics

Drugs are patentable, granting exclusivity rights typically for 20 years.^{[citation needed]} However, it often takes as long as 12 years to approve a drug for patient use.^{[citation needed]} Patent protection enables the owner of the patent to recover the costs of research and development through high profit margins for the branded drug. When the patent protection for the drug expires, a generic drug is usually developed and sold by a competing company. The development and approval of generics is less expensive, allowing them to be sold at a lower price. Often the owner of the branded drug will introduce a generic version before the patent expires in order to get a head start in the generic market.^{[citation needed]} For other uses, see Brand (disambiguation). ... A generic drug (pl. ...

Medicare Part D

In 2003 the United States enacted the Medicare Prescription Drug, Improvement, and Modernization Act (MMA), a program to provide prescription drug benefits to the elderly and disabled. This program is a component of Medicare (United States) and is known as Medicare Part D. This program, set to begin in January 2006, will significantly alter the revenue models for pharmaceutical companies. Revenues from the program are expected to be $724 billion between 2006 and 2015.^[18] The Medicare Prescription Drug, Improvement, and Modernization Act (Public Law No. ... Old age consists of ages nearing the average lifespan of human beings, and thus the end of the human life cycle. ... The term disability, as it is applied to humans, refers to any condition that impedes the completion of daily tasks using traditional methods. ... President Johnson signing the Medicare amendment. ... Medicare Part D is a federal program to subsidize the costs of prescription drugs for Medicare beneficiaries in the United States. ...

Pharmaceuticals developed by biotechnological processes often must be injected in a physician's office rather than be delivered in the form of a capsule taken orally. Medicare payments for these drugs are usually made through Medicare Part B (physician office) rather than Part D (prescription drug plan).

Mergers, acquisitions, and co-marketing of drugs

A merger, acquisition, or co-marketing deal between pharmaceutical companies may occur as a result of complementary capabilities between them. A small biotechnology company might have a new drug but no sales or marketing capability. Conversely, a large pharmaceutical company might have unused capacity in a large sales force due to a gap in the company pipeline of new products. It may be in both companies' interest to enter into a deal to capitalize on the synergy between the companies. The difference between the value of the two companies after the deal and before the deal is known as the synergy value of the deal. The phrase mergers and acquisitions (abbreviated M&A) refers to the aspect of corporate strategy, corporate finance and management dealing with the buying, selling and combining of different companies that can aid, finance, or help a growing company in a given industry grow rapidly without having to create another business... Co-marketing is a marketing practice where two companies cooperate with separate distribution channels, sometimes including profit sharing. ... The structure of insulin Biotechnology is technology based on biology, especially when used in agriculture, food science, and medicine. ... Synergy (from the Greek synergos, συνεργός meaning working together, circa 1660) refers to the phenomenon in which two or more discrete influences or agents acting together create an effect greater than that predicted by knowing only the separate effects of the individual agents. ...

Marketing

Pharmaceutical companies commonly spend a large amount on advertising, marketing and lobbying.^{[citation needed]} In the US, drug companies spend $19 billion a year on promotions.^[6] Advertising is common in healthcare journals as well as through more mainstream media routes.^{[citation needed]} In some countries, notably the US, they are allowed to advertise direct to the general public.^{[citation needed]} Pharmaceutical companies generally employ sales people (often called 'drug reps' or, an older term, 'detail men') to market directly and personally to physicians and other healthcare providers.^{[citation needed]} In some countries, notably the US, pharmaceutical companies also employ lobbyists to influence politicians.^{[citation needed]} Marketing of prescription drugs in the US is regulated by the federal Prescription Drug Marketing Act of 1987.^{[citation needed]} Lobbying is the practice of private advocacy with the goal of influencing a governing body, in order to ensure that an individuals or organizations point of view is represented in the government. ... The Prescription Drug Marketing Act (PDMA) of 1987 (P.L. 100-293, 102 Stat. ...

To healthcare professionals

Physicians are perhaps the most important players in pharmaceutical sales because they write the prescriptions that determine which drugs will be used by the patient. Influencing the physician is often seen as the key to prescription pharmaceutical sales.^[19] A medium-sized pharmaceutical company might have a sales force of 1000 representatives. The largest companies have tens of thousands of representatives. Currently, there are approximately 100,000 pharmaceutical sales reps in the United States pursuing some 120,000 pharmaceutical prescribers.^[20] The number doubled in the four years from 1999 to 2003. Drug companies spend $5 billion annually sending representatives to physician offices. Pharmaceutical companies use the service of specialized healthcare marketing research companies to perform Marketing research among Physcians and other Healthcare professionals. A specialization of market research that deals with healthcare products or services such as drugs, medical devices, insurances. ...

To insurance and public health bodies

Private insurance or public health bodies (e.g. the NHS in the UK) decide which drugs to pay for, and restrict the drugs that can be prescribed through the use of formularies.

Parts of this article may be confusing or unclear. Please help clarify the article. Suggestions may be on the talk page. (September 2007)

This, along with the high margins companies can realise for their most successful medicines, makes pharmaceutical marketing complex. There are a number of firms that specialize in data and analytics for pharmaceutical marketing (Yellowikis). Image File history File links Broom_icon. ... Pharmaceutical marketing is the business of advertising or otherwise promoting the sale of pharmaceuticals or drugs. ... Look up company in Wiktionary, the free dictionary. ...

Public and private insurers restrict the number and types of drugs that they will cover. Not only can the insurer affect drug sales by including or excluding a particular drug from a formulary, they can affect sales by tiering, or placing bureaucratic hurdles to prescribing certain drugs. In January 2006, the U.S. instituted a new public prescription drug plan through its Medicare program. Known as Medicare Part D, this program engages private insurers to negotiate with pharmaceutical companies for the placement of drugs on tiered formularies. thank you Medicare Part D is a federal program to subsidize the costs of prescription drugs for Medicare beneficiaries in the United States. ...

To retail pharmacies and stores

Commercial stores and pharmacies are a major target of non-prescription sales and marketing for pharmaceutical companies.

Direct to consumer advertising

Main article:Direct-to-consumer advertising

Since the 1980s new methods of marketing for prescription drugs to consumers have become important. Direct-to-consumer media advertising was legalised in the FDA Guidance for Industry on Consumer-Directed Broadcast Advertisements.

Controversy about drug marketing and lobbying

There has been increasing controversy surrounding pharmaceutical marketing and influence. There have been accusations and findings of influence on doctors and other health professionals through drug reps, including the constant provision of marketing 'gifts' and biased information to health professionals;^[21][22] highly prevalent advertising in journals and conferences; funding independent healthcare organizations and health promotion campaigns; lobbying physicians and politicians (more than any other industry in the US;^[23] sponsorship of medical schools or nurse training; sponsorship of continuing educational events, with influence on the curriculum;^[24] and hiring physicians as paid consultants on medical advisory boards. Texas Tech University Health Sciences Center in Lubbock, Texas, USA. A medical school or faculty of medicine is a tertiary educational institution or part of such an institution that teaches medicine. ...

Some advocacy groups, such as No Free Lunch, have criticized the effect of drug marketing to physicians because they say it biases physicians to prescribe the marketed drugs even when others might be cheaper or better for the patient.^[25] This article is about the group. ...

There have been related accusations of disease mongering^[2] (over-medicalising) to expand the market for medications. An inaugural conference on that subject took place in Australia in 2006.^[26] Disease mongering is a term used to describe a perceived attempt by pharmaceutical companies to promote public awareness of (frequently harmless) conditions or diseases with the aim of increasing sales of medication. ...

A 2005 review by a special committee of the UK government came to all the above conclusions in a European Union context^[27] whilst also highlighting the contributions and needs of the industry.

Developing world

The role of pharmaceutical companies in the developing world is a matter of some debate, ranging from those highlighting the aid provided to the developing world, to those critical of the use of the poorest in human clinical trials, often without adequate protections, particularly in states lacking a strong rule of law. Other criticisms include an alleged reluctance of the industry to invest in treatments of diseases in less economically advanced countries, such as malaria; Criticism for the price of patented AIDS medication, which could limit therapeutic options for patients in the Third World, where the most people have AIDS. The term state may refer to: a sovereign political entity, see state unitary state nation state a non-sovereign political entity, see state (non-sovereign). ... The Politics series Politics Portal This box:      The rule of law, in its most basic form, is the principle that no one is above the law. ... Malaria is a vector-borne infectious disease caused by protozoan parasites. ... For other uses, see Patent (disambiguation). ... For other uses, see AIDS (disambiguation). ... For the Jamaican reggae band, see Third World (band). ...

Under World Trade Organization rules, a developing country has options for obtaining needed medications under compulsory licensing or importation of cheaper versions of the drugs, even before patent expiration (WTO Press Release). Pharmaceutical companies often offer much needed medication at no or reduced cost to the developing countries. research and focus their research on other, more profitable areas^{[citation needed]}). In March of 2001, South Africa was sued by 41 pharmaceutical companies for their Medicines Act, which allowed the import and generic production of cheap AIDS drugs. The case was later dropped after protest around the world. “WTO” redirects here. ... A statutory license or compulsory license is a copyright license to use content under reasonable and non-discriminatory terms. ... For other uses, see Patent (disambiguation). ... Year 2001 (MMI) was a common year starting on Monday (link displays the 2001 Gregorian calendar). ... E.W. Kembles Deaths Laboratory in Colliers Magazine in 1906 Patent medicine is the term given to various medical compounds sold under a variety of names and labels, though they were for the most part actually trademarked medicines, not patented. ...

Nigerian clinical trial

In 1996, a pediatric clinical trial conducted on behalf of Pfizer tested the antibiotic Trovan allegedly without first obtaining the informed consent of participants or their parents.^{[28][29][30][31]} Pfizer Incorporated (NYSE: PFE) is the worlds largest research-based pharmaceutical company[1].[1] The company is based in New York City. ... Trovafloxacin (sold as Trovan by Pfizer) is a broad spectrum antibiotic that inhibits DNA supercoiling in various bacteria by blocking the activity of DNA gyrase and topoisomerase IV [1]. It is not used widely due to the risk of hepatotoxicity. ...

Charitable programmes

Charitable programs and drug discovery & development efforts are routinely undertaken by phamaceutical companies. Some examples include:

• "Merck's Gift," wherein billions of River Blindness drugs were donated in Africa ^[32]
• Pfizer's gift of free/discounted fluconazole and other drugs for AIDS in South Africa ^[33]
• GSK's commitment to give free albendazole tablets to the WHO for, and until, the elimination of lymphatic filariasis worldwide.
• In 2006, Novartis committed USD 755 million in corporate citizenship initiatives around the world, particularly focusing on improved access to medicines in the developing world through its Access to Medicine projects, including donations of medicines to patients affected by leprosy, tuberculosis, and malaria; Glivec patient assistance programmes; and relief to support major humanitarian organisations with emergency medical needs.^[34]

Merck & Co. ... Onchocerciasis or river blindness is the worlds second leading infectious cause of blindness. ... Pfizer Incorporated (NYSE: PFE) is the worlds largest research-based pharmaceutical company[1].[1] The company is based in New York City. ... Fluconazole (INN) (IPA: ) is a triazole antifungal drug used in the treatment and prevention of superficial and systemic fungal infections. ... For other uses, see AIDS (disambiguation). ... GlaxoSmithKline plc (LSE: GSK NYSE: GSK) is a British based pharmaceutical, biological, and healthcare company. ... Novartis Suffern Yes plant is the Swiss companys sole pharmaceutical production facility in the U.S. Novartis International AG is a multinational pharmaceutical company based in Basel, Switzerland that manufactures mainstream products such as Benefiber (a fiber supplement) and Lamisil (a foot fungus medicine). ... For the malady found in the Hebrew Bible, see the article Tzaraath. ... Tuberculosis (abbreviated as TB for tubercle bacillus or Tuberculosis) is a common and deadly infectious disease caused by mycobacteria, mainly Mycobacterium tuberculosis. ... Malaria is a vector-borne infectious disease caused by protozoan parasites. ... Imatinib mesylate (or simply imatinib) is a new drug used to treat certain types of cancer. ...

Industry associations

• European Federation of Pharmaceutical Industries and Associations (EFPIA)
• European Pharmaceutical Market Research Association (EphMRA)
• International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)
• Japan Pharmaceutical Manufacturers Association (JPMA)
• New York Health Products Council (NYHPC)
• Pharmaceutical Research and Manufacturers of America (PhRMA)
• Irish Pharmaceutical Healthcare Association (IPHA)

The European Federation of Pharmaceutical Industries and Associations or EFPIA is the organization representing the research-based pharmaceutical industry operating in Europe. ... The IFPMA is the International Federation of Pharmaceutical Manufacturers and Associations. ... The Japan Pharmaceutical Manufacturers Association or JPMA is the organization representing the research-based pharmaceutical industry operating in Japan. ... Pharmaceutical Research and Manufacturers of America (PhRMA) is a trade group representing the pharmaceutical research and biotechnology companies in the United States. ...

Regulatory authorities

• International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
• European Medicines Agency (EMEA)
• Food and Drug Administration (FDA)
• Ministry of Health, Labour and Welfare (Japan)
• Medicines and Healthcare products Regulatory Agency (MHRA)

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical... The European Medicines Agency (EMEA) is a European agency for the evaluation of medicinal products. ... “FDA” redirects here. ... The Ministry of Health, Labour and Welfare (厚生労働省; Kōsei-rōdō-shō) is one of ministries in the Japanese government. ... The logo of the MHRA. The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK government agency which is responsible for ensuring that medicines and medical devices work and are acceptably safe. ...

See also

Alternative medicine has been described as any of various systems of healing or treating disease (as chiropractic, homeopathy, or faith healing) not included in the traditional medical curricula taught in the United States and Britain.[1] Alternative medicine practices are often based in belief systems not derived from modern science. ... Map of the human X chromosome (from the NCBI website). ... The structure of insulin Biotechnology is technology based on biology, especially when used in agriculture, food science, and medicine. ... Cautionary and advisory labels (Cals) are sometimes added (with the dispensing label) to a medicine dispensed by the pharmacist to the patient. ... Cheminformatics (also known as chemoinformatics and chemical informatics) is the use of computer and informational techniques, applied to a range of problems in the field of chemistry. ... In health care, including medicine, a clinical trial (synonyms: clinical studies, research protocols, medical research) is a process in which a medicine or other medical treatment is tested for its safety and effectiveness, often in comparison to existing treatments. ... Comparison of the perceived harm for various psychoactive drugs from a poll among medical psychiatrists specialized in addiction treatment[1] This article is an overview of the nontherapeutic use of alcohol and drugs of abuse. ... It has been suggested that this article or section be merged into Pharmacology. ... Drug design is the approach of finding drugs by design, based on their biological targets. ... In medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are discovered and/or designed. ... A generic drug (pl. ... This article or section does not adequately cite its references or sources. ... Ancient Greek painting in a vase, showing a physician (iatros) bleeding a patient. ... A listing of diseases. ... This multi-page article lists drugs alphabetically by name. ... The top 10 pharmaceuticals by 2004 sales are: Forbes 2004 Categories: | ... // The following is a list of the largest pharmaceutical and biotech companies ranked by healthcare revenue. ... Medicare Part D is a federal program to subsidize the costs of prescription drugs for Medicare beneficiaries in the United States. ... The Medicare Prescription Drug, Improvement, and Modernization Act (Public Law No. ... For the chemical substances known as medicines, see medication. ... A National Pharmaceuticals Policy is one that aims at ensuring that people get good quality drugs at the lowest possible price, and that doctors prescribe the minimum of required drugs in order to treat the patients illness. ... The granting of the orphan drug status is designed to encourage the development of drugs which are necessary but would be prohibitively expensive/un-profitable to develop under normal circumstances. ... Pharmaceutical marketing is the business of advertising or otherwise promoting the sale of pharmaceuticals or drugs. ... The Pharmaceutical lobby, also known as the drug lobby, refers to the paid representatives of large pharmaceutical and biomedicine companies who seek to influence government policy. ... Pharmacology (in Greek: pharmakon (φάρμακον) meaning drug, and lego (λέγω) to tell (about)) is the study of how drugs interact with living organisms to produce a change in function. ... Physiologically-based pharmacokinetic modeling (PBPK) is a mathematical modelling technique for prediction of the absorption, distribution, metabolization and excretion (AMDE) of a compound in humans and other species used in pharmaceutical research. ... Predictive analytics encompasses a variety of techniques from statistics and data mining that process current and historical data in order to make “predictions” about future events. ... Prescription drug prices in the United States are significantly higher than in Canada and other countries, many of which have price controls. ... Protein structure prediction is one of the most significant technologies pursued by computational structural biology and theoretical chemistry. ... A rare disease (sometimes known as an orphan disease) has such a low prevalence in a population that a doctor in a busy general practice would not expect to see more than one case a year. ... Traditional Chinese medicine shop in Tsim Sha Tsui, Hong Kong. ... Escherichia coli bacteria, which are often utilized in production of pharmaceutical products. ...

Notes

Bain & Company is a management consulting firm, headquartered in Boston, MA, that is recognized as one of the leading business institutions in the world. ... Year 2004 (MMIV) was a leap year starting on Thursday of the Gregorian calendar. ... is the 48th day of the year in the Gregorian calendar. ... Medline is a comprehensive literature database of life sciences and biomedical information. ... Year 2007 (MMVII) is the current year, a common year starting on Monday of the Gregorian calendar and the AD/CE era in the 21st century. ... is the 144th day of the year (145th in leap years) in the Gregorian calendar. ... Year 2007 (MMVII) is the current year, a common year starting on Monday of the Gregorian calendar and the AD/CE era in the 21st century. ... is the 279th day of the year (280th in leap years) in the Gregorian calendar. ... Year 2003 (MMIII) was a common year starting on Wednesday of the Gregorian calendar. ... is the 341st day of the year (342nd in leap years) in the Gregorian calendar. ... Wikipedia does not yet have an article with this exact name. ... Year 2007 (MMVII) is the current year, a common year starting on Monday of the Gregorian calendar and the AD/CE era in the 21st century. ... is the 144th day of the year (145th in leap years) in the Gregorian calendar. ... Medline is a comprehensive literature database of life sciences and biomedical information. ... Also see: 2002 (number). ... is the 145th day of the year (146th in leap years) in the Gregorian calendar. ... Year 2007 (MMVII) is the current year, a common year starting on Monday of the Gregorian calendar and the AD/CE era in the 21st century. ... is the 144th day of the year (145th in leap years) in the Gregorian calendar. ... Year 2005 (MMV) was a common year starting on Saturday (link displays full calendar) of the Gregorian calendar. ... is the 147th day of the year (148th in leap years) in the Gregorian calendar. ... Medline is a comprehensive literature database of life sciences and biomedical information. ... Year 2007 (MMVII) is the current year, a common year starting on Monday of the Gregorian calendar and the AD/CE era in the 21st century. ... is the 144th day of the year (145th in leap years) in the Gregorian calendar. ... Year 2007 (MMVII) is the current year, a common year starting on Monday of the Gregorian calendar and the AD/CE era in the 21st century. ... is the 151st day of the year (152nd in leap years) in the Gregorian calendar. ... Year 2007 (MMVII) is the current year, a common year starting on Monday of the Gregorian calendar and the AD/CE era in the 21st century. ... is the 267th day of the year (268th in leap years) in the Gregorian calendar. ... Year 2006 (MMVI) was a common year starting on Sunday of the Gregorian calendar. ... is the 81st day of the year (82nd in leap years) in the Gregorian calendar. ... This article or section does not adequately cite its references or sources. ... Year 2007 (MMVII) is the current year, a common year starting on Monday of the Gregorian calendar and the AD/CE era in the 21st century. ... is the 151st day of the year (152nd in leap years) in the Gregorian calendar. ... Year 2005 (MMV) was a common year starting on Saturday (link displays full calendar) of the Gregorian calendar. ... is the 244th day of the year (245th in leap years) in the Gregorian calendar. ... Year 2007 (MMVII) is the current year, a common year starting on Monday of the Gregorian calendar and the AD/CE era in the 21st century. ... is the 152nd day of the year (153rd in leap years) in the Gregorian calendar. ... This article or section contains information that has not been verified and thus might not be reliable. ... Year 2004 (MMIV) was a leap year starting on Thursday of the Gregorian calendar. ... is the 48th day of the year in the Gregorian calendar. ... Year 2007 (MMVII) is the current year, a common year starting on Monday of the Gregorian calendar and the AD/CE era in the 21st century. ... is the 152nd day of the year (153rd in leap years) in the Gregorian calendar. ... Year 2006 (MMVI) was a common year starting on Sunday of the Gregorian calendar. ... is the 297th day of the year (298th in leap years) in the Gregorian calendar. ... Year 2007 (MMVII) is the current year, a common year starting on Monday of the Gregorian calendar and the AD/CE era in the 21st century. ... is the 170th day of the year (171st in leap years) in the Gregorian calendar. ... Year 2007 (MMVII) is the current year, a common year starting on Monday of the Gregorian calendar and the AD/CE era in the 21st century. ... is the 170th day of the year (171st in leap years) in the Gregorian calendar. ... The Henry J. Kaiser Family Foundation (KFF), or just Kaiser Family Foundation, is a U.S.-based non-profit philanthropic private operating foundation headquartered in Menlo Park, California. ... Year 2007 (MMVII) is the current year, a common year starting on Monday of the Gregorian calendar and the AD/CE era in the 21st century. ... is the 163rd day of the year (164th in leap years) in the Gregorian calendar. ... Year 2007 (MMVII) is the current year, a common year starting on Monday of the Gregorian calendar and the AD/CE era in the 21st century. ... is the 1st day of the year in the Gregorian calendar. ... Year 2007 (MMVII) is the current year, a common year starting on Monday of the Gregorian calendar and the AD/CE era in the 21st century. ... is the 171st day of the year (172nd in leap years) in the Gregorian calendar. ... Year 2007 (MMVII) is the current year, a common year starting on Monday of the Gregorian calendar and the AD/CE era in the 21st century. ... is the 171st day of the year (172nd in leap years) in the Gregorian calendar. ... Year 2007 (MMVII) is the current year, a common year starting on Monday of the Gregorian calendar and the AD/CE era in the 21st century. ... is the 143rd day of the year (144th in leap years) in the Gregorian calendar. ... ... Year 2005 (MMV) was a common year starting on Saturday (link displays full calendar) of the Gregorian calendar. ... is the 126th day of the year (127th in leap years) in the Gregorian calendar. ... Year 2007 (MMVII) is the current year, a common year starting on Monday of the Gregorian calendar and the AD/CE era in the 21st century. ... is the 143rd day of the year (144th in leap years) in the Gregorian calendar. ... Year 2005 (MMV) was a common year starting on Saturday (link displays full calendar) of the Gregorian calendar. ... is the 188th day of the year (189th in leap years) in the Gregorian calendar. ... Year 2007 (MMVII) is the current year, a common year starting on Monday of the Gregorian calendar and the AD/CE era in the 21st century. ... is the 143rd day of the year (144th in leap years) in the Gregorian calendar. ... Year 2003 (MMIII) was a common year starting on Wednesday of the Gregorian calendar. ... is the 151st day of the year (152nd in leap years) in the Gregorian calendar. ... Year 2007 (MMVII) is the current year, a common year starting on Monday of the Gregorian calendar and the AD/CE era in the 21st century. ... is the 280th day of the year (281st in leap years) in the Gregorian calendar. ... Year 2007 (MMVII) is the current year, a common year starting on Monday of the Gregorian calendar and the AD/CE era in the 21st century. ... is the 279th day of the year (280th in leap years) in the Gregorian calendar. ... Year 2007 (MMVII) is the current year, a common year starting on Monday of the Gregorian calendar and the AD/CE era in the 21st century. ... is the 143rd day of the year (144th in leap years) in the Gregorian calendar. ... Year 2007 (MMVII) is the current year, a common year starting on Monday of the Gregorian calendar and the AD/CE era in the 21st century. ... is the 143rd day of the year (144th in leap years) in the Gregorian calendar. ... Year 2000 (MM) was a leap year starting on Saturday (link will display full 2000 Gregorian calendar). ... December 17 is the 351st day of the year (352nd in leap years) in the Gregorian calendar. ... Year 2007 (MMVII) is the current year, a common year starting on Monday of the Gregorian calendar and the AD/CE era in the 21st century. ... is the 176th day of the year (177th in leap years) in the Gregorian calendar. ... Year 2001 (MMI) was a common year starting on Monday (link displays the 2001 Gregorian calendar). ... is the 258th day of the year (259th in leap years) in the Gregorian calendar. ... Year 2007 (MMVII) is the current year, a common year starting on Monday of the Gregorian calendar and the AD/CE era in the 21st century. ... is the 176th day of the year (177th in leap years) in the Gregorian calendar. ... Year 2001 (MMI) was a common year starting on Monday (link displays the 2001 Gregorian calendar). ... is the 27th day of the year in the Gregorian calendar. ... Year 2007 (MMVII) is the current year, a common year starting on Monday of the Gregorian calendar and the AD/CE era in the 21st century. ... is the 176th day of the year (177th in leap years) in the Gregorian calendar. ... Year 2007 (MMVII) is the current year, a common year starting on Monday of the Gregorian calendar and the AD/CE era in the 21st century. ... is the 176th day of the year (177th in leap years) in the Gregorian calendar. ...

Further reading

• Coyne J. Lessons in conflict of interest: “The construction of the martyrdom of David Healy and the dilemma of bioethics.” American Journal of Bioethics 5 (1): W3-W14, 2005.
• Ray Moynihan, Alan Cassels: Selling sickness: How the world's biggest pharmaceutical companies are turning us all into patients. Nation Books, New York, 2005.
• Merrill Goozner: The $800 million pill. University of California Press, Berkeley, 2004, 297 S. ISBN 0-520-23945-8.
• Marcia Angell: The truth about the drug companies. Random House, New York, 2004, 305 S. ISBN 0-375-50846-5.
• Diana A. Taylor: HEALTHYWORDS Towards a Betterment in Medical Communications across the Drug Industry ISBN 3-8288-9083-0 Tectum Verlag 2006 S.187
• Joanna Moncrieff, "An Unholy Alliance? Psychiatry and the influence of the pharmaceutical industry", Spinwatch, 27 June 2006.
• E. Kumar Sharma, "The best Pharmaceutical company to work for in India", Business Today, October 26, 2007.