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Pharmaceutical company



 
 
The pharmaceutical industry develops, produces, and markets drug
Drug

A drug, broadly speaking, is any chemical substance that, when absorbed into the body of a living organism, alters normal bodily function....
s license
License

The verb license or grant license means to give permission. The noun license refers to that permission as well as to the document memorializing that permission....
d for use as medication
Medication

A pharmaceutical drug, also referred to as medicine or medicament, can be loosely defined as any substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease....
s. Pharmaceutical companies can deal in generic
Generic drug

A generic drug is a medication which isproduced and distributed without patent protection. The generic drug may still have a patent on the formulation but not on the active ingredient....
 and/or brand
Brand

A brand is a collection of symbols, experiences and associations connected with a product, a service, a person or any other artifact or entity....
 medications. They are subject to a variety of laws and regulations regarding the patenting, testing and marketing of drugs.

earliest drugstores
Pharmacy

Pharmacy is the health profession that links the health sciences with the chemistrys, and it is charged with ensuring the safe and effective use of medication....
 date back to the Middle Ages
Middle Ages

File:Karl 1 mit papst gelasius gregor1 sacramentar v karl d kahlen.jpgThe Middle Ages of European history are a period in history which lasted for roughly a millennium, commonly dated from the fall of the Roman Empire in the 5th century to the beginning of the Early Modern Period in the 16th century, marked by the division of Western Christi...
. The first known drugstore was opened by Arabian pharmacists
Islamic medicine

In the history of medicine, Islamic medicine or Arabic medicine refers to medicine developed in the Islamic Golden Age and written in Arabic language, the lingua franca of the Islamic civilization....
 in Baghdad
Baghdad

Baghdad is the Capital of Iraq and of Baghdad Governorate, with which it is also coterminous. With a municipal population estimated at 6.5 million, it is the largest city in Iraq, and the second largest city in the Arab World....
 in 754, and many more soon began operating throughout the medieval Islamic world
Islamic Golden Age

The Islamic Golden Age, also sometimes known as the Islamic Renaissance, was traditionally dated from the 700 A.D. to 1200 A.D.Common Era, but has been extended to the 15th and 16th centuries by some scholars....
 and eventually medieval Europe
Europe

Europe is, conventionally, one of the world's seven continents. Comprising the westernmost peninsula of Eurasia, Europe is generally divided from Asia to its east by the water divide of the Ural Mountains, the Ural , the Caspian Sea, and by the Caucasus Mountains to the southeast....
.






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The pharmaceutical industry develops, produces, and markets drug
Drug

A drug, broadly speaking, is any chemical substance that, when absorbed into the body of a living organism, alters normal bodily function....
s license
License

The verb license or grant license means to give permission. The noun license refers to that permission as well as to the document memorializing that permission....
d for use as medication
Medication

A pharmaceutical drug, also referred to as medicine or medicament, can be loosely defined as any substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease....
s. Pharmaceutical companies can deal in generic
Generic drug

A generic drug is a medication which isproduced and distributed without patent protection. The generic drug may still have a patent on the formulation but not on the active ingredient....
 and/or brand
Brand

A brand is a collection of symbols, experiences and associations connected with a product, a service, a person or any other artifact or entity....
 medications. They are subject to a variety of laws and regulations regarding the patenting, testing and marketing of drugs.

History

The earliest drugstores
Pharmacy

Pharmacy is the health profession that links the health sciences with the chemistrys, and it is charged with ensuring the safe and effective use of medication....
 date back to the Middle Ages
Middle Ages

File:Karl 1 mit papst gelasius gregor1 sacramentar v karl d kahlen.jpgThe Middle Ages of European history are a period in history which lasted for roughly a millennium, commonly dated from the fall of the Roman Empire in the 5th century to the beginning of the Early Modern Period in the 16th century, marked by the division of Western Christi...
. The first known drugstore was opened by Arabian pharmacists
Islamic medicine

In the history of medicine, Islamic medicine or Arabic medicine refers to medicine developed in the Islamic Golden Age and written in Arabic language, the lingua franca of the Islamic civilization....
 in Baghdad
Baghdad

Baghdad is the Capital of Iraq and of Baghdad Governorate, with which it is also coterminous. With a municipal population estimated at 6.5 million, it is the largest city in Iraq, and the second largest city in the Arab World....
 in 754, and many more soon began operating throughout the medieval Islamic world
Islamic Golden Age

The Islamic Golden Age, also sometimes known as the Islamic Renaissance, was traditionally dated from the 700 A.D. to 1200 A.D.Common Era, but has been extended to the 15th and 16th centuries by some scholars....
 and eventually medieval Europe
Europe

Europe is, conventionally, one of the world's seven continents. Comprising the westernmost peninsula of Eurasia, Europe is generally divided from Asia to its east by the water divide of the Ural Mountains, the Ural , the Caspian Sea, and by the Caucasus Mountains to the southeast....
. By the 19th century, many of the drug stores in Europe and North America
North America

North America is the northern continent of the Americas, situated in the Earth's northern hemisphere and almost totally in the western hemisphere....
 had eventually developed into larger pharmaceutical companies.

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
Insulin

Insulin is a hormone with extensive effects on both metabolism and several other body systems . Insulin causes most of the body's cells to take up glucose from the blood , storing it as glycogen in the liver and muscle, and stops use of fat as an energy source....
 and penicillin
Penicillin

Penicillin is a group of antibiotics derived from Penicillium fungi. They are Beta-lactam antibiotics used in the treatment of bacterial infections caused by susceptible, usually Gram-positive, organisms....
, became mass-manufactured and distributed. Switzerland, Germany and Italy had particularly strong industries, with the UK, US, Belgium and the Netherlands following suit.

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
DNA

Deoxyribonucleic acid is a nucleic acid that contains the genetics instructions used in the development and functioning of all known living organisms and some viruses....
) and sophisticated manufacturing techniques.

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
Chlorpromazine

Chlorpromazine is a phenothiazine antipsychotic, and the oldest in the antipsychotic family of drugs. It is a typical antipsychotic. It is principally used in the treatment of schizophrenia, though it has also been used to treat severe manic episodes in people with bipolar disorder....
 (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.

Attempts were made to increase regulation and to limit financial links between companies and prescribing physicians, including by the relatively new US FDA. Such calls increased in the 1960s after the thalidomide
Thalidomide

Thalidomide is a sedative-hypnotic, and multiple myeloma medication. The drug is a potent Teratology in rabbits and primates including humans: this means that severe birth defects may result if the drug is taken during pregnancy....
 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
Declaration of Helsinki

The Declaration of Helsinki, was developed by the World Medical Association , as a set of ethical principles for the medical community regarding human experimentation....
, 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
Efficacy

Efficacy is the capacity to produce an effect.It is these conditions that distinguish efficacy from the related concept of effectiveness, which relates to change under real-life conditions....
 in clinical trials before marketing drugs.

Cancer drugs were a feature of the 1970s. From 1978, India took over as the primary center of pharmaceutical production without patent protection.

The industry remained relatively small scale until the 1970s when it began to expand at a greater rate. 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. 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
Managed care

The term managed care is used to describe a variety of techniques intended to reduce the cost of providing health benefits and improve the quality of care organizations that use those techniques or provide them as services to other organizations , or systems of financing and delivering health care to enrollees organized around managed care...
 and Health maintenance organization
Health maintenance organization

A health maintenance organization is a type of managed care that provides a form of health insurance in the United States that is fulfilled through hospitals, doctors, and other providers with which the HMO has a contract....
s (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
Animal rights

Animal rights, also known as animal liberation, is the idea that the most basic interests of animals should be afforded the same consideration as the similar interests of human beings....
 activism was also a problem.

Marketing changed dramatically in the 1990s, partly because of a new consumerism. 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
Fluoxetine

Fluoxetine hydrochloride is an antidepressant of the selective serotonin reuptake inhibitor class. Fluoxetine is approved for the treatment of major depressive disorder , obsessive-compulsive disorder , bulimia nervosa, anorexia nervosa, panic disorder and premenstrual dysphoric disorder....
 (Prozac), rapidly became bestsellers and marketed for additional disorders.

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
Disease mongering

Disease mongering is a pejorative term for a perceived practice of widening the diagnostic boundaries of illnesses, and promoting public awareness of such, in order to expand the markets for those who sell and deliver treatments, which may include pharmaceutical company, physicians, and other professional or consumer organizations....
 or over-medicalizing personal or social problems.

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. Advances in biotechnology and the human genome project promise ever more sophisticated, and possibly more individualized, medications.

Research and development

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
Serendipity

Serendipity is the effect by which one accidentally discovers something fortunate, especially while looking for something else entirely. The word has been voted as one of the ten English words that were Words hardest to translate in June 2004 by a United Kingdom translation company....
 discovery. Modern biotechnology
Biotechnology

Biotechnology is technology based on biology, especially when used in agriculture, food science, and medicine. United Nations Convention on Biological Diversity defines biotechnology as:...
 often focuses on understanding the metabolic pathway
Metabolic pathway

In biochemistry, a metabolic pathway is a series of chemistry reactions occurring within a cell . In each pathway, a principal chemical is modified by chemical reactions....
s related to a disease
Disease

A disease or medical condition is an abnormal condition of an organism that impairs bodily functions, associated with specific symptoms and Medical signs....
 state or pathogen
Pathogen

A pathogen , infectious agent, or germ, is a biological agent that causes disease or illness to its Host .There are several substrates and pathways whereby pathogens can invade a host; the principal pathways have different episodic time frames, but soil contamination has the longest or most persistent potential for harboring...
, and manipulating these pathways using molecular biology
Molecular biology

Molecular biology is the study of biology at a molecule level. The field overlaps with other areas of biology and chemistry, particularly genetics and biochemistry....
 or Biochemistry
Biochemistry

Biochemistry is the study of the chemistry processes in living organisms. It deals with the structure and function of cellular components such as proteins, carbohydrates, lipids, nucleic acids and other biomolecules....
. A great deal of early-stage drug discovery has traditionally been carried out by universities and research institutions.

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
Formulation

Formulation may refer to:* clinical formulation* Pesticide formulation* Pharmaceutical formulation...
 and Dosing
Dosing

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....
, as well as to establish safety. Research in these areas generally includes a combination of in vitro
In vitro

In vitro refers to the technique of performing a given procedure in a controlled environment outside of a living organism. Some may argue that in vitro refers to a process that is created in a "test tube"; however, Robert Kail and John Cavanaugh on page 58 in the 4th edition of Human Development: A Life-Span View cite that in fact th...
 studies, in vivo
In vivo

In vivo means that which takes place inside an organism. In science, in vivo refers to experimentation done in or on the living tissue of a whole, living organism as opposed to a partial or dead one or a in vitro....
 studies, and clinical trials. The amount of capital required for late stage development has made it a historical strength of the larger pharmaceutical companies. Suggested citation: Tufts Center for the Study of Drug Development, Annual Impact Report, http://csdd.tufts.edu/

Often, large multinational corporations exhibit vertical integration
Vertical integration

In microeconomics and management, the term vertical integration describes a style of management control. Vertically integrated companies are united through a hierarchy with a common owner....
, 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.

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 in most nations by government appointed medical institutions or boards, who have to approve new drugs before they can be marketed in those countries. 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
Pre-clinical development

Pre-clinical development is a stage of research that begins before clinical trials can begin, and during which important feasibility, iterative testing and safety data is collected....
 and clinical trial
Clinical trial

In health care, clinical trials are conducted to allow safety and efficacy data to be collected for new drugs or devices. These trials can only take place once satisfactory information has been gathered on the quality of the product and its non-clinical safety, and Institutional review board approval is granted in the country where the trial...
s, as well as a commitment to ongoing safety monitoring
Safety monitoring

Safety Monitoring of a clinical trial is conducted by an independent physician with relevant expertise. This is accomplished by review of adverse event, immediately after they occur, with timely follow-up through resolution....
. 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
New chemical entity

According to the U.S. Food and Drug Administration, a new chemical entity is a drug that contains no active moiety that has been approved by FDA in any other application submitted under section 505 of the Federal Food, Drug, and Cosmetic Act."...
 or NCE), has been estimated at about 1 billion USD(not including marketing expenses). A study by the consulting firm Bain & Company
Bain & Company

Bain & Company is a management consulting firm headquartered in Boston, Massachusetts....
 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.

These estimates also take into account the opportunity cost
Opportunity cost

Opportunity cost or economic opportunity loss is the value of the next best alternative foregone as the result of making a decision. Opportunity cost analysis is an important part of a company's decision-making processes but is not treated as an actual cost in any financial statement....
 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
Active ingredient

An active ingredient , also active pharmaceutical ingredient or bulk active, is the substance in a medication that is pharmaceutically active....
 (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.

Calculations and claims in this area are controversial because of the implications for regulation and subsidization of the industry through federally funded research grants.

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.

In response to specific cases in which unfavorable data from pharmaceutical company-sponsored research was not published, the Pharmaceutical Research and Manufacturers of America
Pharmaceutical Research and Manufacturers of America

Pharmaceutical Research and Manufacturers of America is an industry trade group representing the pharmaceutical research and biotechnology companies in the United States....
 have published new guidelines urging companies to report all findings and limit the financial involvement in drug companies of researchers. US congress signed into law a bill which requires phase II and phase III clinical trials to be registered by the sponsor on the clinicaltrials.gov website run by the NIH.

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. 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.

Product approval in the US


In the United States
United States

The United States of America is a Federal government constitutional republic comprising U.S. state and a federal district. The country is situated mostly in central North America, where its Contiguous United States and Washington, D.C., the Capital districts and territories, lie between the Pacific Ocean and Atlantic Oceans, Borders of the U...
, 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
IND

IND may be:* the List of IOC country codes country code, and ISO 3166-1 alpha-3 code for , used by the Republic of India* An abbreviation for the Institute of Notre Dame, a high school in Baltimore, Maryland...
 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
Toxicity

Toxicity is the degree to which a substance is able to damage an exposed organism. Toxicity can refer to the effect on a whole organism, such as an animal, bacterium, or plant, as well as the effect on a substructure of the organism, such as a cell or an organ , such as the liver ....
 using healthy volunteers. Phase II can include Pharmacokinetics
Pharmacokinetics

Pharmacokinetics is a branch of pharmacology dedicated to the determination of the fate of substances administered externally to a living organism....
 and Dosing
Dosing

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 patients, and Phase III is a very large study of efficacy in the intended patient population.

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. Questions continue to be raised regarding the standard of both the initial approval process, and subsequent changes to product labeling (it may take many months for a change identified in post-approval surveillance to be reflected in product labeling) and this is an area where congress is active.

The FDA provides information about approved drugs at the Orange Book site.

Orphan drugs

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. 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.

Legal issues

Where pharmaceutics have been shown to cause side-effects, civil action has occurred, especially in countries where tort
Tort

Tort law is the name given to a body of law that addresses, and provides remedies for, civil wrongs not arising out of contractual obligations. A person who suffers legal damages may be able to use tort law to receive compensation from someone who is liability, or "liable," for those injuries....
 payouts are likely to be large. Due to high-profile cases leading to large compensations, most pharmaceutical companies endorse tort reform
Tort reform

Tort reform refers to proposed changes in the civil justice system that would reduce tort litigation or damages. Tort is a system for compensating wrongs and harm done by one party to another's person, property or other protected interests ....
. Recent controversies have involved Vioxx and SSRI antidepressants.

Product approval elsewhere


In many non-US western countries a 'fourth hurdle' of cost effectiveness analysis has developed before new technologies can be provided. This focuses on the efficiciency (in terms of the cost per QALY) of the technologies in question rather than their efficacy. In England NICE
Nice

Nice is a city in Southern France France located on the Mediterranean Sea coast, between Marseille, France, and Genoa, Italy, with 1,197,751 inhabitants in the 2007 estimate....
 approval is required before technologies can be adopted by the NHS, whilst similar arrangements exist with the Scottish Medical Consortium in Scotland and the Pharmaceutical Benefits Advisory Committee in Australia. A product must pass the threshold for cost-effectiveness if it is to be approved. Treatments must represent 'value for money' and a net benefit to society. There is much speculation that a NICE style framework may be implemented in the USA to ensure Medicare and Medicaid spending is focused to maximise benefit to patients and not excessive profits for the pharmaceutical industry.

In the UK, the British National Formulary
British National Formulary

The British National Formulary contains a wide spectrum of information on Medical prescription and pharmacology, among others indications, side effects and costs of the medical prescription of all medications available on the National Health Service....
 is the core guide for pharmacists and clinicians.

Industry revenues

For the first time ever, in 2006, global spending on prescription drugs topped $643 billion, even as growth slowed somewhat in Europe and North America. The United States accounts for almost half of the global pharmaceutical market, with $289 billion in annual sales followed by the EU and Japan. Emerging markets such as China, Russia, South Korea and Mexico outpaced that market, growing a huge 81 percent.

US profit growth was maintained even whilst other top industries saw slowed or no growth. Despite this, "..the pharmaceutical industry is — and has been for years — the most profitable of all businesses in the U.S. In the annual Fortune 500 survey, the pharmaceutical industry topped the list of the most profitable industries, with a return of 17% on revenue."

Pfizer's cholesterol pill Lipitor
Atorvastatin

Atorvastatin , is a member of the drug class known as statins, used for lowering blood cholesterol. It also stabilizes plaque and prevents strokes through anti-inflammatory and other mechanisms....
 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
Clopidogrel

Clopidogrel is an oral Antiplatelet drug to inhibit blood clots in coronary artery disease, peripheral vascular disease, and cerebrovascular disease....
, the blood thinner from Bristol-Myers Squibb and Sanofi-Aventis; Nexium
Esomeprazole

Esomeprazole is a proton pump inhibitor developed and marketed by AstraZeneca which is used in the treatment of dyspepsia, peptic ulcer , gastroesophageal reflux disease and Zollinger-Ellison syndrome....
, the heartburn pill from AstraZeneca; and Advair
Fluticasone/salmeterol

The combination preparation fluticasone/salmeterol is a formulation containing fluticasone propionate and salmeterol used in the management of asthma and chronic obstructive pulmonary disease ....
, the asthma inhaler from GlaxoSmithKline.

IMS Health
IMS Health

IMS Health is an international consulting and data services company that supplies the pharmaceutical industry with sales data and consulting services....
 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.

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

Market leaders in terms of revenue

The following is a list of the 20 largest pharmaceutical and biotech companies ranked by healthcare revenue. Some companies (eg, Bayer
Bayer

Bayer Aktiengesellschaft is a Germany chemical industry and pharmaceutical company founded in Barmen, Germany in 1863. Today it is headquartered in Leverkusen, North Rhine-Westphalia, Germany....
, Johnson and Johnson and Procter & Gamble
Procter & Gamble

Procter & Gamble Co. is a Fortune 500, United States multinational corporation headquartered in Cincinnati, Ohio, that manufactures a wide range of Fast moving consumer goods....
) have additional revenue not included here. The phrase Big Pharma is often used to refer to companies with revenue in excess of $3 billion, and/or R&D expenditure in excess of $500 million.


Revenue Rank 2006CompanyCountryTotal Revenues (USD millions)Healthcare R&D 2006 (USD millions)Net income/ (loss) 2006 (USD millions)Employees 2006
1Johnson and JohnsonUSA53,3247,12511,053138,000
2Pfizer
Pfizer

Pfizer Incorporated is a major pharmaceutical company, ranking number one in sales in the world. The company is based in New York City, and its research headquarters is in Groton, Connecticut....
USA48,3717,59919,337122,200
3Bayer
Bayer

Bayer Aktiengesellschaft is a Germany chemical industry and pharmaceutical company founded in Barmen, Germany in 1863. Today it is headquartered in Leverkusen, North Rhine-Westphalia, Germany....
Germany
Germany

Germany , officially the Federal Republic of Germany , is a country in Central Europe. It is bordered to the north by the North Sea, Denmark, and the Baltic Sea; to the east by Poland and the Czech Republic; to the south by Austria and Switzerland; and to the west by France, Luxembourg, Belgium, and the Netherlands....
44,2001,7916,450106,200
4GlaxoSmithKline
GlaxoSmithKline

GlaxoSmithKline plc is a United Kingdom-based pharmaceutical industry, biological, and healthcare company. GSK is the world's second largest pharmaceutical company and a research-based company with a wide portfolio of pharmaceutical products covering anti-infectives, central nervous system, respiratory, gastro-intestinal/metabolic,...
United Kingdom
United Kingdom

The United Kingdom of Great Britain and Northern Ireland, commonly known as the United Kingdom , the UK or Britain,is a sovereign state located off the northwestern coast of continental Europe....
42,8136,37310,135106,000
5Novartis
Novartis

Novartis International AG is a multinational corporation pharmaceutical company based in Basel, Switzerland that manufactures drugs such as clozapine , diclofenac , carbamazepine , valsartan , imatinib mesylate , ciclosporin , letrozole , methylphenidate , terbinafine , and others....
Switzerland
Switzerland

Switzerland is a landlocked Swiss Alps country of roughly 7.7 million people in Western Europe with an area of 41,285 km?. Switzerland is a federal republic consisting of 26 states called Cantons of Switzerland....
37,0205,3497,202102,695
6Sanofi-Aventis
Sanofi-Aventis

Sanofi-Aventis , headquartered in Paris, France, is a multinational pharmaceutical company. The company is the world's fourth largest List of pharmaceutical companies....
France
France

France , officially the French Republic , is a country whose Metropolitan France is located in Western Europe and that also comprises various Overseas departments and territories of France....
35,6455,5655,033100,735
7Hoffmann–La RocheSwitzerland33,5475,2587,318100,289
8AstraZeneca
AstraZeneca

AstraZeneca plc , is a large Anglo-Swedish pharmaceutical company formed on 6 April 1999 by the remerger of Swedish Astra AB and British Zeneca Group plc....
UK/Sweden26,4753,9026,06398,000
9Merck & Co.
Merck & Co.

Merck & Co., Inc. , also known as Merck Sharp & Dohme or MSD outside the USA and Canada, is one of the largest pharmaceutical companies in the world....
USA22,6364,7834,43474,372
10Abbott Laboratories
Abbott Laboratories

Abbott Laboratories is a diversified Pharmacology health care company. It has 68,000 employees and operates in 130 countries. The corporate headquarters are in Abbott Park, Illinois, located near North Chicago, Illinois....
USA22,4762,2551,71766,800
11Wyeth
Wyeth

Wyeth, formerly known as American Home Products , is one of the largest pharmaceutical company in the world. The company is based in Madison, New Jersey....
USA20,3513,1094,19766,663
12Bristol-Myers Squibb
Bristol-Myers Squibb

Bristol-Myers Squibb , colloquially referred to as BMS, is a pharmaceutical corporation, formed by a 1989 merger between pharmaceutical companies Bristol-Myers Company, founded in 1887 by William McLaren Bristol and John Ripley Myers in Clinton, NY , and E.R....
USA17,9143,0671,58560,000
13Eli Lilly and Company
Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company and one of the world's largest corporations. Eli Lilly's global headquarters is located in Indianapolis, Indiana, in the United States....
USA15,6913,1292,66350,060
14Amgen
Amgen

Amgen Inc. is an international biotechnology Corporation headquartered in Thousand Oaks, California. Located in the Conejo Valley, it is one of the top corporations in the area....
USA14,2683,3662,95048,000
15Boehringer IngelheimGermany 13,2841,9772,16343,000
16Schering-Plough
Schering-Plough

Schering-Plough Corporation is a pharmaceutical company founded in 1851 by Ernst Schering as Schering in Germany. Following the entry of the United States into World War II in 1941, U.S....
USA10,5942,1881,05741,500
17Baxter International
Baxter International

Baxter International Inc. , is a global healthcare company with 48,000 employees and 2006 sales of US$10.4 billion. Its headquarters is in Deerfield, Illinois....
USA10,3786141,39738,428
18Takeda Pharmaceutical Co.Japan
Japan

Japan is an island country in East Asia. Located in the Pacific Ocean, it lies to the east of the Sea of Japan, People's Republic of China, North Korea, South Korea and Russia, stretching from the Sea of Okhotsk in the north to the East China Sea and Taiwan in the south....
10,2841,6202,87015,000
19Genentech
Genentech

Genentech Inc. , a composite of Genetic Engineering Technology, Inc., is a leading biotechnology corporation, which was founded in 1976 by venture capitalist Robert A....
USA9,2841,7732,11333,500
20Procter & Gamble
Procter & Gamble

Procter & Gamble Co. is a Fortune 500, United States multinational corporation headquartered in Cincinnati, Ohio, that manufactures a wide range of Fast moving consumer goods....
USA8,964n/a10,34029,258


Source: Top 50 Pharmaceutical Companies Charts & Lists, Med Ad News, September 2007

Market leaders in terms of sales

The top ten pharmaceutical companies by 2006 sales are:
Rank Company Sales ($m) Growth (%) Market Share (%) Based/Headquartered in
1 Pfizer
Pfizer

Pfizer Incorporated is a major pharmaceutical company, ranking number one in sales in the world. The company is based in New York City, and its research headquarters is in Groton, Connecticut....
 
45,983 2.1 7.3 US
2 GlaxoSmithKline
GlaxoSmithKline

GlaxoSmithKline plc is a United Kingdom-based pharmaceutical industry, biological, and healthcare company. GSK is the world's second largest pharmaceutical company and a research-based company with a wide portfolio of pharmaceutical products covering anti-infectives, central nervous system, respiratory, gastro-intestinal/metabolic,...
 
37,034 9.7 5.9 UK
3 Sanofi-Aventis
Sanofi-Aventis

Sanofi-Aventis , headquartered in Paris, France, is a multinational pharmaceutical company. The company is the world's fourth largest List of pharmaceutical companies....
 
35,638 5.0 5.7 France
France

France , officially the French Republic , is a country whose Metropolitan France is located in Western Europe and that also comprises various Overseas departments and territories of France....
4 Novartis
Novartis

Novartis International AG is a multinational corporation pharmaceutical company based in Basel, Switzerland that manufactures drugs such as clozapine , diclofenac , carbamazepine , valsartan , imatinib mesylate , ciclosporin , letrozole , methylphenidate , terbinafine , and others....
 
28,880 18.0 4.6 Switzerland
Switzerland

Switzerland is a landlocked Swiss Alps country of roughly 7.7 million people in Western Europe with an area of 41,285 km?. Switzerland is a federal republic consisting of 26 states called Cantons of Switzerland....
5 Hoffmann–La Roche 26,596 21.8 4.2 Switzerland
Switzerland

Switzerland is a landlocked Swiss Alps country of roughly 7.7 million people in Western Europe with an area of 41,285 km?. Switzerland is a federal republic consisting of 26 states called Cantons of Switzerland....
6 AstraZeneca
AstraZeneca

AstraZeneca plc , is a large Anglo-Swedish pharmaceutical company formed on 6 April 1999 by the remerger of Swedish Astra AB and British Zeneca Group plc....
 
25,741 10.5 4.1 UK/Sweden
Sweden

Sweden , officially the Kingdom of Sweden , is a Nordic countries on the Scandinavian Peninsula in Northern Europe. Sweden has land borders with Norway to the west and Finland to the northeast, and it is connected to Denmark by the ?resund Bridge in the south....
7 Johnson & Johnson
Johnson & Johnson

Johnson & Johnson is a global United States pharmaceutical, medical devices and consumer packaged goods manufacturer founded in 1886. Its common stock is a component of the Dow Jones Industrial Average and the company is listed among the Fortune 500....
 
23,267 4.2 3.7 US
8 Merck & Co.
Merck & Co.

Merck & Co., Inc. , also known as Merck Sharp & Dohme or MSD outside the USA and Canada, is one of the largest pharmaceutical companies in the world....
 
22,636 2.8 3.6 US
9 Wyeth
Wyeth

Wyeth, formerly known as American Home Products , is one of the largest pharmaceutical company in the world. The company is based in Madison, New Jersey....
 
15,683 2.4 2.5 US
10 Eli Lilly and Company
Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company and one of the world's largest corporations. Eli Lilly's global headquarters is located in Indianapolis, Indiana, in the United States....
 
14,814 7.5 2.4 US


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.

Patents and generics


Depending on a number of considerations, a company may apply for and be granted a patent
Chemical patent

A chemical patent or pharmaceutical patent is a patent for an invention in the chemical industry or pharmaceuticals industry. Strictly speaking, in most jurisdictions, there are essentially no differences between the legal requirements to obtain a patent for an invention in the chemical or pharmaceutical fields, in comparison to obtain...
 for the drug, or the process of producing the drug, granting exclusivity rights typically for about 20 years. However, only after rigorous study and testing, which takes 10 to 15 years on average, will governmental authorities grant permission for the company to market and sell the drug. Patent protection enables the owner of the patent to recover the costs of research and development through high profit margins for the brand
Brand

A brand is a collection of symbols, experiences and associations connected with a product, a service, a person or any other artifact or entity....
ed drug. When the patent protection for the drug expires, a generic drug
Generic drug

A generic drug is a medication which isproduced and distributed without patent protection. The generic drug may still have a patent on the formulation but not on the active ingredient....
 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.

Medicare Part D

In 2003 the United States enacted the Medicare Prescription Drug, Improvement, and Modernization Act
Medicare Prescription Drug, Improvement, and Modernization Act

The Medicare Prescription Drug, Improvement, and Modernization Act is a law of the United States which was enacted in 2003. It produced the largest overhaul of Medicare in the public health program's 38-year history....
 (MMA), a program to provide prescription drug benefits to the elderly and disabled. This program is a component of Medicare (United States)
Medicare (United States)

Medicare is a social insurance program administered by the United States government, providing health insurance coverage to people who are aged 65 and over, or who meet other special criteria....
 and is known as Medicare Part D
Medicare Part D

Medicare Part D is a federal program to subsidy the costs of prescription drugs for Medicare beneficiaries in the United States. It was enacted as part of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and went into effect on January 1, 2006....
. 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.

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
Mergers and acquisitions

The phrase mergers and acquisitions refers to the aspect of corporate strategy, corporate finance and management dealing with the buying, selling and combining of different corporation that can aid, finance, or help a growing company in a given industry grow rapidly without having to create another business entity....
, or co-marketing
Co-marketing

Co-marketing is a marketing practice where two company cooperate with separate Distribution channels, sometimes including profit sharing. It is frequently confused with Co-promotion....
 deal between pharmaceutical companies may occur as a result of complementary capabilities between them. A small biotechnology
Biotechnology

Biotechnology is technology based on biology, especially when used in agriculture, food science, and medicine. United Nations Convention on Biological Diversity defines biotechnology as:...
 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.

Prescriptions

In the U.S. , prescriptions have increased over the past decade to 3.4 billion annually, a 61 percent increase. Retail sales of prescription drugs jumped 250 percent from $72 billion to $250 billion, while the average price of prescriptions has more than doubled from $30 to $68.



Publications

The drug company Merck & Co.
Merck & Co.

Merck & Co., Inc. , also known as Merck Sharp & Dohme or MSD outside the USA and Canada, is one of the largest pharmaceutical companies in the world....
 publishes the Merck Manual of Diagnosis and Therapy
Merck Manual of Diagnosis and Therapy

The Merck Manual of Diagnosis and Therapy, often called simply The Merck Manual, is the world's best-selling medical textbook. First published in 1899, it is now in its 18th edition....
, the world's best-selling medical textbook, and the Merck Index
Merck Index

The Merck Index is an encyclopedia of chemicals, medication and biomolecules with over 10,000 monographs on single substances or groups of related chemical compounds....
, a collection of information about chemical compounds.

Marketing


Pharmaceutical companies commonly spend a large amount on advertising, marketing and lobbying. In the US, drug companies spend $19 billion a year on promotions. Advertising is common in healthcare journals as well as through more mainstream media routes. In some countries, notably the US, they are allowed to advertise direct to the general public. 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. In some countries, notably the US, pharmaceutical companies also employ lobbyists to influence politicians. Marketing of prescription drugs in the US is regulated by the federal Prescription Drug Marketing Act of 1987
Prescription Drug Marketing Act (PDMA)

The Prescription Drug Marketing Act of 1987 is a law of the United States federal government. It establishes legal safeguards for prescription drug distribution to ensure safe and effective pharmaceuticals....
.

To healthcare professionals

Physicians, physician assistants, and nurse practitioners 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. 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. 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 Physicians and other Healthcare professionals.

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. Public and private insurers restrict the brands, types and number 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 as well. In January 2006, the U.S. instituted a new public prescription drug plan through its Medicare program known as Medicare Part D
Medicare Part D

Medicare Part D is a federal program to subsidy the costs of prescription drugs for Medicare beneficiaries in the United States. It was enacted as part of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and went into effect on January 1, 2006....
. This program engages private insurers to negotiate with pharmaceutical companies for the placement of drugs on tiered formularies.

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


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; 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; sponsorship of medical school
Medical school

A medical school is a tertiary educational institution?or part of such an institution?that teaches medicine.In addition to a medical degree program, some medical schools offer programs leading to a Master's Degree, Doctor of Philosophy , or other post-secondary education....
s or nurse training; sponsorship of continuing educational events, with influence on the curriculum; and hiring physicians as paid consultants on medical advisory boards.

To help ensure the status quo on U.S. drug regulation and pricing, the pharmaceutical industry has thousands of lobbyists in Washington, DC that lobby Congress and protect their interests. The pharmaceutical industry spent $855 million, more than any other industry, on lobbying activities from 1998 to 2006, according to the non-partisan Center for Public Integrity.

Some advocacy groups, such as No Free Lunch
No Free Lunch (organization)

No Free Lunch is a United States-based advocacy organization that holds that marketing methods employed by drug companies influence the way doctors and other healthcare providers prescribe medications....
, 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.

There have been related accusations of disease mongering
Disease mongering

Disease mongering is a pejorative term for a perceived practice of widening the diagnostic boundaries of illnesses, and promoting public awareness of such, in order to expand the markets for those who sell and deliver treatments, which may include pharmaceutical company, physicians, and other professional or consumer organizations....
 (over-medicalising) to expand the market for medications. An inaugural conference on that subject took place in Australia in 2006.

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

There is also huge concern about the influence of the pharmaceutical industry on the scientific process. Meta-analyses have shown that studies sponsored by pharmaceutical companies are several times more likely to report positive results, and if a drug company employee is involved (as is often the case, often multiple employees as co-authors and helped by contracted marketing companies) the effect is even larger. Influence has also extended to the training of doctors and nurses in medical schools, which is being fought.

It has been argued that the design of the Diagnostic and Statistical Manual of Mental Disorders
Diagnostic and Statistical Manual of Mental Disorders

The Diagnostic and Statistical Manual of Mental Disorders is published by the American Psychiatric Association and provides diagnostic criteria for classification of mental disorders....
 and the expansion of the criteria represents an increasing medicalization of human nature, or "disease mongering
Disease mongering

Disease mongering is a pejorative term for a perceived practice of widening the diagnostic boundaries of illnesses, and promoting public awareness of such, in order to expand the markets for those who sell and deliver treatments, which may include pharmaceutical company, physicians, and other professional or consumer organizations....
", driven by drug company influence on psychiatry. The potential for direct conflict of interest
Conflict of interest

A conflict of interest occurs when an individual or organization has an interest that might compromise their reliability. A conflict of interest exists even if no improper act results from it, and can create an appearance of impropriety that can undermine confidence in the conflicted individual or organization....
 has been raised, partly because roughly half the authors who selected and defined the DSM-IV psychiatric disorders had or previously had financial relationships with the pharmaceutical industry. The president of the organisation that designs and publishes the DSM, the American Psychiatric Association
American Psychiatric Association

The American Psychiatric Association is the main professional organization of psychiatrists and trainee psychiatrists in the United States, and the most influential world-wide....
, recently acknowledged that in general American psychiatry has "allowed the biopsychosocial model to become the bio-bio-bio model" and routinely accepted "kickbacks and bribes" from pharmaceutical companies.

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
Rule of law

The rule of law is a legal concept which includes a number of interrelated principles. First, protecting the rule of law ensures that no one is above the law....
. Other criticisms include an alleged reluctance of the industry to invest in treatments of diseases in less economically advanced countries, such as malaria
Malaria

Malaria is a Vector -borne infectious disease caused by protozoan parasites. It is widespread in Tropics and subtropical regions, including parts of the Americas, Asia, and Africa....
; Criticism for the price of patent
Patent

A patent is a set of exclusive rights granted by a state to an inventor or his assignee for a term of patent in exchange for a disclosure of an invention....
ed AIDS
AIDS

Acquired immune deficiency syndrome or acquired immunodeficiency syndrome is a disease of the human immune system caused by the HIV ....
 medication, which could limit therapeutic options for patients in the Third World
Third World

Third World is a categorical label used to describe states that are considered to be developed in terms of their economy or level of industrialization, globalization, standard of living, health, education or other criteria for 'advancements'....
, where the most people have AIDS.

In September 2008 the was launched in India to combat infectious diseases common to developing countries.

Patents

Under World Trade Organization
World Trade Organization

The World Trade Organization is an international organization designed to supervise and Free trade international trade. The WTO came into being on 1 January 1995, and is the successor to the General Agreement on Tariffs and Trade , which was created in 1947, and continued to operate for almost five decades as a de facto international org...
 rules, a developing country has options for obtaining needed medications under compulsory licensing or importation of cheaper versions of the drugs, even before patent
Patent

A patent is a set of exclusive rights granted by a state to an inventor or his assignee for a term of patent in exchange for a disclosure of an invention....
 expiration . Pharmaceutical companies often offer much needed medication at no or reduced cost to the developing countries. Proposals to allow the manufacture of generic AIDS drugs are not without controversy; it is sometimes claimed that this might cause pharmaceutical companies to move away from AIDS drug research and focus their research on other, more profitable areas). In March 2001, South Africa
South Africa

The Republic of South Africa, also known by Official names of South Africa, is a country located at the southern tip of the continent of 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.

Nigerian clinical trial

In 1996, a pediatric clinical trial conducted on behalf of Pfizer
Pfizer

Pfizer Incorporated is a major pharmaceutical company, ranking number one in sales in the world. The company is based in New York City, and its research headquarters is in Groton, Connecticut....
 tested the antibiotic Trovan
Trovafloxacin

Trovafloxacin is a broad spectrum antibiotic that inhibits the uncoiling of supercoiling DNA in various bacteria by blocking the activity of DNA gyrase and topoisomerase IV....
 allegedly without first obtaining the informed consent of participants or their parents.

Charitable programmes

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

  • "Merck
    Merck & Co.

    Merck & Co., Inc. , also known as Merck Sharp & Dohme or MSD outside the USA and Canada, is one of the largest pharmaceutical companies in the world....
    's Gift," wherein billions of River Blindness drugs were donated in Africa
  • Pfizer
    Pfizer

    Pfizer Incorporated is a major pharmaceutical company, ranking number one in sales in the world. The company is based in New York City, and its research headquarters is in Groton, Connecticut....
    's gift of free/discounted fluconazole
    Fluconazole

    Fluconazole is a triazole antifungal drug used in the treatment and prevention of superficial and systemic fungal infections. In a bulk powder form, it appears as a white crystalline powder, and it is very slightly soluble in water and soluble in alcohol....
     and other drugs for AIDS
    AIDS

    Acquired immune deficiency syndrome or acquired immunodeficiency syndrome is a disease of the human immune system caused by the HIV ....
     in South Africa
    South Africa

    The Republic of South Africa, also known by Official names of South Africa, is a country located at the southern tip of the continent of Africa....
     
  • GSK
    GlaxoSmithKline

    GlaxoSmithKline plc is a United Kingdom-based pharmaceutical industry, biological, and healthcare company. GSK is the world's second largest pharmaceutical company and a research-based company with a wide portfolio of pharmaceutical products covering anti-infectives, central nervous system, respiratory, gastro-intestinal/metabolic,...
    's commitment to give free albendazole tablets to the WHO for, and until, the elimination of lymphatic filariasis worldwide.
  • In 2006, Novartis
    Novartis

    Novartis International AG is a multinational corporation pharmaceutical company based in Basel, Switzerland that manufactures drugs such as clozapine , diclofenac , carbamazepine , valsartan , imatinib mesylate , ciclosporin , letrozole , methylphenidate , terbinafine , and others....
     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
    Leprosy

    Leprosy , or Hansen's disease , is a Chronic disease caused by the bacteria Mycobacterium leprae and Mycobacterium lepromatosis. Leprosy is primarily a granulomatous disease of the Peripheral nervous system and Mucous membrane of the upper respiratory tract; skin lesions are the primary external symptom....
    , tuberculosis
    Tuberculosis

    Tuberculosis is a common and often deadly infectious disease caused by mycobacterium, mainly Mycobacterium tuberculosis . Tuberculosis usually attacks the lungs but can also affect the central nervous system, the lymphatic system, the circulatory system, the genitourinary system, the gastrointestinal system, bones, joints, and even the...
    , and malaria
    Malaria

    Malaria is a Vector -borne infectious disease caused by protozoan parasites. It is widespread in Tropics and subtropical regions, including parts of the Americas, Asia, and Africa....
    ; Glivec patient assistance programmes; and relief to support major humanitarian organisations with emergency medical needs.


However, some NGOs such as Médecins Sans Frontières
Médecins Sans Frontières

M?decins Sans Fronti?res , or Doctors Without Borders, is a Secularism humanitarian aid non-governmental organization best known for its projects in war-torn regions and developing country facing Endemic ....
 do not routinely accept corporate donations of medicines. More precisely, they do not become reliant on such supplies of medicines because the supply is dependent upon the fluid, profit-driven charities of said pharmaceutical companies, and thus may dry up during a critical or otherwise important time. [citation: "An Imperfect Offering" by ex-MSF president James Orbinski
James Orbinski

James Jude Orbinski is a Canadian physician, writer and humanitarian activist. He is an Associate Professor of Medicine at the University of Toronto and a Fellow at the Munk Centre for International Studies....
]

Industry associations

  • European Federation of Pharmaceutical Industries and Associations
    European Federation of Pharmaceutical Industries and Associations

    Founded in 1978, the European Federation of Pharmaceutical Industries and Associations or 'EFPIA' represents the research-based pharmaceutical industry operating in Europe....
     (EFPIA)
  • European Pharmaceutical Market Research Association (EphMRA)
  • International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)
  • Japan Pharmaceutical Manufacturers Association
    Japan Pharmaceutical Manufacturers Association

    The Japan Pharmaceutical Manufacturers Association or JPMA is the organization representing the research-based pharmaceutical industry operating in Japan....
     (JPMA)
  • New York Health Products Council (NYHPC)
  • Pharmaceutical Research and Manufacturers of America
    Pharmaceutical Research and Manufacturers of America

    Pharmaceutical Research and Manufacturers of America is an industry trade group representing the pharmaceutical research and biotechnology companies in the United States....
     (PhRMA)
  • Irish Pharmaceutical Healthcare Association
    Irish Pharmaceutical Healthcare Association

    The Irish Pharmaceutical Healthcare Association represents manufacturers of prescription medicines and non-prescription or consumer health care medicines in Ireland....
     (IPHA)


Regulatory authorities

  • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
  • European Medicines Agency
    European Medicines Agency

    The European Medicines Agency is a European agency for the evaluation of medication. From 1995 to 2004, the European Medicines Agency was known as The European Agency for the Evaluation of Medicinal Products....
     (EMEA)
  • Food and Drug Administration
    Food and Drug Administration

    The U.S. Food and Drug Administration is an Government agency of the United States Department of Health and Human Services and is responsible for regulating and supervising the safety of foods, dietary supplements, Medications, vaccines, Biopharmaceutical, blood transfusion, medical devices, Electromagnetic radiation-emitting devices, veteri...
     (FDA)
  • Ministry of Health, Labour and Welfare (Japan)
    Ministry of Health, Labour and Welfare (Japan)

    The is a Cabinet level ministry of the Japanese government. It is commonly known as Koro-sho in Japan. This ministry provides regulations on maximum residue limits for agricultural chemicals in foods, basic food and drug regulations, standards for foods, food additives, etc....
  • Medicines and Healthcare products Regulatory Agency
    Medicines and Healthcare products Regulatory Agency

    The Medicines and Healthcare products Regulatory Agency is the UK government agency which is responsible for ensuring that medicines and medical devices work and are acceptably safe....
     (MHRA)
  • Central Drugs Standards Control Organisation(India) CDSCO
  • Ukrainian Drug Registration Agency


See also

  • Biotechnology
    Biotechnology

    Biotechnology is technology based on biology, especially when used in agriculture, food science, and medicine. United Nations Convention on Biological Diversity defines biotechnology as:...
  • Cautionary and advisory label
    Cautionary and advisory label

    Cautionary and advisory labels are sometimes added to a medicine dispensed by the pharmacist to the patient.A dispensing label is always added to a medicine to show the essential details , and in some cases the pharmacist will add cautionary and advisory labels....
  • Clinical trial
    Clinical trial

    In health care, clinical trials are conducted to allow safety and efficacy data to be collected for new drugs or devices. These trials can only take place once satisfactory information has been gathered on the quality of the product and its non-clinical safety, and Institutional review board approval is granted in the country where the trial...
  • Contamination control
    Contamination control

    Contamination control is the generic term for all activities aiming to control the existence, growth and proliferation of contamination in certain areas....
  • Cost effectiveness analysis
  • Drug development
    Drug development

    Drug development or preclinical development is defined in many pharmaceutical companies as the process of taking a new chemical lead through the stages necessary to allow it to be tested in human clinical trials, although a broader definition would encompass the entire process of drug discovery and clinical testing of novel drug candida...
  • Drug design
    Drug design

    Drug design is the approach of finding medication by design, based on their biological targets. Typically a drug target is a key molecule involved in a particular metabolic or signalling Metabolic pathway that is specific to a disease condition or pathology, or to the infectivity or survival of a Microorganism pathogen....
  • Drug discovery
    Drug discovery

    In medicine, biotechnology and pharmacology, drug discovery is the process by which medication are discovered and/or designed.In the past most drugs have been discovered either by identifying the active ingredient from traditional remedies or by serendipity discovery....
  • Generic drug
    Generic drug

    A generic drug is a medication which isproduced and distributed without patent protection. The generic drug may still have a patent on the formulation but not on the active ingredient....
  • Health care system
    Health care system

    Health care systems are designed to meet the health care needs of target populations. There are a wide variety of health care systems around the world....
  • List of top selling drugs
  • List of pharmaceutical companies
    List of pharmaceutical companies

    The following is a list of the 50 largest pharmaceutical and biotech companies ranked by healthcare revenue. Some companies have additional revenue not included here....
  • National pharmaceuticals policy
    National pharmaceuticals policy

    A National Pharmaceuticals Policy is one that aims at ensuring that people get good quality Medication at the lowest possible price, and that doctors prescribe the minimum of required drugs in order to treat the patient's illness....
  • NICE
    Nice

    Nice is a city in Southern France France located on the Mediterranean Sea coast, between Marseille, France, and Genoa, Italy, with 1,197,751 inhabitants in the 2007 estimate....
  • Orphan drug
    Orphan drug

    The term orphan drug refers to a medication that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an rare disease....
  • Pharmaceutical marketing
    Pharmaceutical marketing

    Pharmaceutical marketing is the business of advertising or otherwise promoting the sale of pharmaceuticals or medication.Evidence show that marketing practices can negatively effect both patients and the health care profession....
  • Pharmaceutical lobby
    Pharmaceutical lobby

    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....
  • Prescription drug prices in the United States
    Prescription drug prices in the United States

    Prescription drug prices in the United States are the highest in the world. "The prices Americans pay for prescription drugs, which are far higher than those paid by citizens of any other developed country, help explain why the pharmaceutical industry is ? and has been for years ? the most profitable of all businesses in the U.S....
  • Use of biotechnology in pharmaceutical manufacturing
    Use of biotechnology in pharmaceutical manufacturing

    Modern pharmaceutical manufacturing techniques frequently rely upon biotechnology....


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.
  • 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


Economics of the industry

  • Merrill Goozner: . University of California Press, Berkeley, 2004, 297 S. ISBN 0-520-23945-8.


Relationship between pharma and the medical profession

  • Joanna Moncrieff, "", Spinwatch, 27 June 2006.
  • Jaconelli T, "", Lancet, 2008.


Relationship between pharma and consumers (general public)

  • Ray Moynihan, Alan Cassels: Selling sickness: How the world's biggest pharmaceutical companies are turning us all into patients. Nation Books, New York, 2005.


Industry trends