Agency name	Food and Drug Administration
Parent agency	Department of Health and Human Services
Logo	Food and Drug Administration logo.svg
Logo width	200px
Logo caption	FDA Logo
Formed	1906 |preceding1 Food, Drug, and Insecticide Administration (July 1927 to July 1930)
Preceding2	Bureau of Chemistry, USDA (July 1901 through July 1927)
Preceding3	Division of Chemistry, USDA (Established 1862)
Jurisdiction	Federal government of the United States
Headquarters	White Oak Campus, 10903 New Hampshire Ave, Silver Spring, MD 20993
Employees	9,300 (2008)
Budget	$2.3 billion (2008)
Chief1 name	Margaret Hamburg
Chief1 position	Commissioner of Food and Drugs
Website	fda.gov }}

The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics.

The FDA also enforces other laws, notably Section 361 of the Public Health Service Act and associated regulations, many of which are not directly related to food or drugs. These include sanitation requirements on interstate travel and control of disease on products ranging from certain household pets to sperm donation for assisted reproduction.

The FDA is led by the Commissioner of Food and Drugs, appointed by the President with the advice and consent of the Senate. The Commissioner reports to the Secretary of Health and Human Services. The 21st and current Commissioner is Dr. Margaret A. Hamburg. She has served as Commissioner since February 2009.

The FDA has its headquarters at White Oak, Maryland.The agency also has 223 field offices and 13 laboratories located throughout the 50 states, the United States Virgin Islands, and Puerto Rico. In 2008, the FDA started opening offices in foreign countries, including China, India, Costa Rica, Chile, Belgium, and the United Kingdom.

Organization

The FDA comprises several offices and centers. There are

Office of the Commissioner

Center for Biologics Evaluation and Research

Center for Devices and Radiological Health (CDRH)

*Office of the Center Director

*Office of Communication, Education, and Radiation Programs

*Office of Compliance

*Office of Device Evaluation

*Office of In Vitro Diagnostic Device Evaluation and Safety

*Office of Management Operations

*Office of Science and Engineering Laboratories

*Office of Surveillance and Biometrics

Center for Drug Evaluation and Research (CDER)

*Office of the Center Director

**Advisory Committee Staff

**Controlled Substance Staff

*Office of Compliance

**Division of Compliance Risk Management and Surveillance

**Division of Manufacturing and Product Quality

**Division of New Drugs and Labeling Compliance

**Division of Scientific Investigations

*Office of Medical Policy

**Division of Drug Marketing, Advertising and Communications8

*Office of New Drugs

*Office of Nonprescription Products

*Office of Oncology Drug Products

**Radioactive Drug Research Committee (RDRC) Program

*Office of Pharmaceutical Science

**Office of Biotechnology Products

**Office of Generic Drugs

**Office of New Drugs Quality Assessment

**Office of Testing and Research

***Division of Applied Pharmacology Research

***Division of Pharmaceutical Analysis

***Division of Product Quality Research

****Informatics and Computational Safety Analysis Staff (ICSAS)

*Office of Surveillance and Epidemiology (formerly Office of Drug Safety)

*Office of Translational Sciences23

**Office of Biostatistics

**Office of Clinical Pharmacology

***Pharmacometrics Staff

*Division of Drug Information

**FDA Pharmacy Student Experiential Program

*Botanical Review Team

*Maternal Health Team

Center for Food Safety and Applied Nutrition

Center for Tobacco Products

Center for Veterinary Medicine

National Center for Toxicological Research

Office of Regulatory Affairs

In recent years, the agency began undertaking a large-scale effort to consolidate its operations in the Washington Metropolitan Area from its main headquarters in Rockville and several fragmented office buildings in the vicinity to the former site of the Naval Ordnance Laboratory in the White Oak area of Silver Spring, Maryland. When the FDA arrived, the site was renamed from the White Oak Naval Surface Warfare Center to the Federal Research Center at White Oak. The first building, the Life Sciences Laboratory, was dedicated and opened with 104 employees on the campus in December 2003. The project is slated to be completed by 2013.

While most of the Centers are located around the Washington, D.C., area as part of the Headquarters divisions, two offices - the Office of Regulatory Affairs (ORA) and the Office of Criminal Investigations (OCI) - are primarily field offices with a workforce spread across the country.

The Office of Regulatory Affairs is considered the "eyes and ears" of the agency, conducting the vast majority of the FDA's work in the field. Consumer Safety Officers, more commonly called Investigators, are the individuals who inspect production and warehousing facilities, investigate complaints, illnesses, or outbreaks, and review documentation in the case of medical devices, drugs, biological products, and other items where it may be difficult to conduct a physical examination or take a physical sample of the product. The Office of Regulatory Affairs is divided into five regions, which are further divided into 13 districts. Districts are based roughly on the geographic divisions of the federal court system. Each district comprises a main district office, and a number of Resident Posts, which are FDA offices located away from the district office to serve a particular geographic area. ORA also includes the Agency's network of laboratories, which analyze any physical samples taken. Though samples are usually food-related, some laboratories are equipped to analyze drugs, cosmetics, and radiation-emitting devices.

The Office of Criminal Investigations was established in 1991 to investigate criminal cases. Unlike ORA Investigators, OCI Special Agents are armed, and are not focused on the technical aspects of the regulated industries. OCI agents pursue and develop cases where criminal actions have occurred, such as fraudulent claims, or knowingly and willfully shipping known adulterated goods in interstate commerce. In many cases, OCI will pursue cases where Title 18 violations have occurred (e.g. conspiracy, false statements, wire fraud, mail fraud), in addition to prohibited acts as defined in Chapter III of the FD&C; Act. OCI Special Agents often come from other criminal investigations backgrounds, and work closely with the Federal Bureau of Investigation, Assistant Attorney General, and even Interpol. OCI will receive cases from a variety of sources, including ORA, local agencies, and the FBI, and will work with ORA investigators to help develop the technical and science-based aspects of a case. OCI is a smaller branch, comprising about 200 agents nationwide.

The FDA frequently works in conjunction with other federal agencies including the Department of Agriculture, Drug Enforcement Administration, Customs and Border Protection, and Consumer Product Safety Commission. Often local and state government agencies also work in cooperation with the FDA to provide regulatory inspections and enforcement action.

Scope and funding

The FDA regulates more than $1 trillion worth of consumer goods, about 25% of consumer expenditures in the United States. This includes $466 billion in food sales, $275 billion in drugs, $60 billion in cosmetics and $18 billion in vitamin supplements. Much of the expenditures is for goods imported into the United States; the FDA is responsible for monitoring a third of all imports.

The FDA's federal budget request for fiscal year (FY) 2008 (October 2007 through September 2008) totaled $2.1 billion, a $105.8 million increase from what it received for fiscal year 2007. In February 2008, the FDA announced that the Bush Administration's FY 2009 budget request for the agency was just under $2.4 billion: $1.77 billion in budget authority (federal funding) and $628 million in user fees. The requested budget authority was an increase of $50.7 million more than the FY 2008 funding - about a three percent increase. In June 2008, Congress gave the agency an emergency appropriation of $150 million for FY 2008 and another $150 million.

Legal authority

Most federal laws concerning the FDA are part of the Food, Drug and Cosmetic Act, (first passed in 1938 and extensively amended since) and are codified in Title 21, Chapter 9 of the United States Code. Other significant laws enforced by the FDA include the Public Health Service Act, parts of the Controlled Substances Act, the Federal Anti-Tampering Act, as well as many others. In many cases these responsibilities are shared with other federal agencies.

Important enabling legislation for the FDA includes: 1902 Biologics Control Act 1906 Pure Food and Drug Act 1938 Federal Food, Drug, and Cosmetic Act 1944 Public Health Service Act 1951 1951 Food, Drug, and Cosmetics Act Amendments PL 82–215 1962 1962 Food, Drug, and Cosmetics Act Amendments PL 87–781 1966 Fair Packaging and Labeling Act PL 89–755 1976 Medical Device Regulation Act PL 94–295 1987 Prescription Drug Marketing Act 1988 Anti–drug Abuse Act PL 100–690 1990 Nutrition Labeling and Education Act PL 101–535 1992 Prescription Drug User Fee Act PL 102–571 1994 Dietary Supplement Health and Education Act 1997 Food and Drug Administration Modernization Act 105-115 2002 Bioterrorism Act 107-188 2002 Medical Device User Fee and Modernization Act (MDUFMA) PL 107-250 2003 Animal Drug User Fee Act PL 108-130 2007 Food and Drug Administration Amendments Act of 2007 2009 Family Smoking Prevention and Tobacco Control Act 2010 FDA Food Safety Modernization Act

Regulatory programs

The programs for safety regulation vary widely by the type of product, its potential risks, and the regulatory powers granted to the agency. For example, the FDA regulates almost every facet of prescription drugs, including testing, manufacturing, labeling, advertising, marketing, efficacy and safety, yet FDA regulation of cosmetics is focused primarily on labeling and safety. The FDA regulates most products with a set of published standards enforced by a modest number of facility inspections. Inspection observations are documented on Form 483.

Food and dietary supplements

The Center for Food Safety and Applied Nutrition is the branch of the FDA which is responsible for ensuring the safety and accurate labeling of nearly all food products in the United States. One exception is meat products derived from traditional domesticated animals, such as cattle and chickens, which fall under the jurisdiction of the United States Department of Agriculture Food Safety and Inspection Service. Products which contain minimal amounts of meat are regulated by FDA, and the exact boundaries are listed in a memorandum of understanding between the two agencies. However, medicines and other products given to all domesticated animals are regulated by the FDA through a different branch, the Center for Veterinary Medicine. Other consumables which are not regulated by the FDA include beverages containing more than 7% alcohol (regulated by the Bureau of Alcohol, Tobacco, Firearms and Explosives in the Department of Justice), and non-bottled drinking water (regulated by the United States Environmental Protection Agency (EPA)).

CFSAN's activities include establishing and maintaining food standards, such as standards of identity (for example, what the requirements are for a product to be labeled, "yogurt") and standards of maximum acceptable contamination. CFSAN also sets the requirements for nutrition labeling of most foods. Both food standards and nutrition labeling requirements are part of the Code of Federal Regulations.

The Dietary Supplement Health and Education Act of 1994 mandated that the FDA regulate dietary supplements as foods, rather than as drugs. Therefore, dietary supplements are not subject to safety and efficacy testing and there are no approval requirements. The FDA can take action against dietary supplements only after they are proven to be unsafe. Manufacturers of dietary supplements are permitted to make specific claims of health benefits, referred to as "structure or function claims" on the labels of these products. They may not claim to treat, diagnose, cure, or prevent disease and must include a disclaimer on the label.

Bottled water is regulated in America by the FDA. State governments also regulate bottled water. Tap water is regulated by state and local regulations, as well as the United States EPA. FDA regulations of bottled water generally follow the guidelines established by the EPA, and new EPA rules automatically apply to bottled water if the FDA does not release an explicit new rule.

Drugs

The Center for Drug Evaluation and Research has different requirements for the three main types of drug products: new drugs, generic drugs and over-the-counter drugs. A drug is considered "new" if it is made by a different manufacturer, uses different excipients or inactive ingredients, is used for a different purpose, or undergoes any substantial change. The most rigorous requirements apply to "new molecular entities": drugs which are not based on existing medications.

New drugs

New drugs receive extensive scrutiny before FDA approval in a process called a New Drug Application or NDA. New drugs are available only by prescription by default. A change to over-the-counter (OTC) status is a separate process, and the drug must be approved through an NDA first. A drug that is approved is said to be "safe and effective when used as directed."

Advertising and promotion

The FDA reviews and regulates prescription drug advertising and promotion. (Other kinds of advertising, including for over-the-counter drugs, are regulated by the Federal Trade Commission). The drug advertising regulation contains two key requirements. Under most circumstances, a company may only advertise a drug for the specific indication or medical use for which it was approved. Also, an advertisement must contain "fair balance" between the benefits and risks of a drug.

The term "off-label" refers to drug usage for indications other than those approved by the FDA.

Postmarket safety surveillance

After approval of an NDA, the sponsor must review and report to the FDA every patient adverse drug experience of which it learns. Unexpected serious and fatal adverse drug events must be reported within 15 days, and other events on a quarterly basis. The FDA also receives directly adverse drug event reports through its MedWatch program. These reports are called "spontaneous reports" because reporting by consumers and health professionals is voluntary. While this remains the primary tool of postmarket safety surveillance, FDA requirements for postmarketing risk management are increasing. As a condition of approval, a sponsor may be required to conduct additional clinical trials, called Phase IV trials. In some cases, the FDA requires risk management plans for some drugs that may provide for other kinds of studies, restrictions, or safety surveillance activities.

Generic drugs

Generic drugs are chemical equivalents of name-brand drugs whose patents have expired. Generally, they are less expensive than their name brand counterparts, are manufactured and marketed by other companies and, in the 1990s, accounted for about a third of all prescriptions written in the United States. For approval of a generic drug, the U.S. Food and Drug Administration (FDA) requires scientific evidence that the generic drug is interchangeable with or therapeutically equivalent to the originally approved drug. This is called an "ANDA" (Abbreviated New Drug Application).

Generic drug scandal

In 1989, a major scandal erupted involving the procedures used by the FDA to approve generic drugs for sale to the public. Charges of corruption in generic drug approval first emerged in 1988, in the course of an extensive congressional investigation into the FDA. The oversight subcommitee of the United States House Energy and Commerce Committee resulted from a complaint brought against the FDA by Mylan Laboratories Inc. of Pittsburgh. When its application to manufacture generics were subjected to repeated delays by the FDA, Mylan, convinced that it was being discriminated against, soon began its own private investigation of the agency in 1987. Mylan eventually filed suit against two former FDA employees and four drug-manufacturing companies, charging that corruption within the federal agency resulted in racketeering and in violations of antitrust law. "The order in which new generic drugs were approved was set by the FDA employees even before drug manufacturers submitted applications" and, according to Mylan, this illegal procedure was followed to give preferential treatment to certain companies. During the summer of 1989, three FDA officials (Charles Y. Chang, David J. Brancato, Walter Kletch) pleaded guilty to criminal charges of accepting bribes from generic drugs makers, and two companies (Par Pharmaceutical and its subsidiary Quad Pharmaceuticals) pleaded guilty to giving bribes. Furthermore, it was discovered that several manufacturers had falsified data submitted in seeking FDA authorization to market certain generic drugs. Vitarine Pharmaceuticals of New York, which sought approval of a generic version of the drug Dyazide, a medication for high blood pressure, submitted Dyazide, rather than its generic version, for the FDA tests. In April 1989, the FDA investigated 11 manufacturers for irregularities; and later brought that number up to 13. Dozens of drugs were eventually suspended or recalled by manufacturers. In the early 1990s, the U.S. Securities and Exchange Commission filed "securities fraud charges against the Bolar Pharmaceutical Company, a major generic manufacturer based in Long Island, New York.

Over-the-counter drugs

Over-the-counter (OTC) drugs are drugs and combinations that do not require a doctor's prescription. The FDA has a list of approximately 800 approved ingredients that are combined in various ways to create more than 100,000 OTC drug products. Many OTC drug ingredients had been previously approved prescription drugs now deemed safe enough for use without a medical practitioner's supervision.

Vaccines, blood and tissue products, and biotechnology

The Center for Biologics Evaluation and Research is the branch of the FDA responsible for ensuring the safety and efficacy of biological therapeutic agents. These include blood and blood products, vaccines, allergenics, cell and tissue-based products, and gene therapy products. New biologics are required to go through a premarket approval process similar to that for drugs. The original authority for government regulation of biological products was established by the 1902 Biologics Control Act, with additional authority established by the 1944 Public Health Service Act. Along with these Acts, the Federal Food, Drug, and Cosmetic Act applies to all biologic products, as well. Originally, the entity responsible for regulation of biological products resided under the National Institutes of Health; this authority was transferred to the FDA in 1972.

Medical and radiation-emitting devices

The Center for Devices and Radiological Health (CDRH) is the branch of the FDA responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices. The definition of a medical device is given in the FD&C; Act, and it includes products from the simple toothbrush to complex devices such as implantable brain pacemakers. CDRH also oversees the safety performance of non-medical devices which emit certain types of electromagnetic radiation. Examples of CDRH-regulated devices include cellular phones, airport baggage screening equipment, television receivers, microwave ovens, tanning booths, and laser products.

CDRH regulatory powers include the authority to require certain technical reports from the manufacturers or importers of regulated products, to require that radiation-emitting products meet mandatory safety performance standards, to declare regulated products defective, and to order the recall of defective or noncompliant products. CDRH also conducts limited amounts of direct product testing.

Cosmetics

Cosmetics are regulated by the Center for Food Safety and Applied Nutrition, the same branch of the FDA that regulates food. Cosmetic products are not generally subject to premarket approval by the FDA unless they make "structure or function claims", which make them into drugs (see Cosmeceutical). However, all color additives must be specifically approved by the FDA before they can be included in cosmetic products sold in the U.S. The labelling of cosmetics is regulated by the FDA, and cosmetics which have not been subjected to thorough safety testing must bear a warning to that effect.

Cosmetic products

Though the cosmetic industry is predominantly responsible in ensuring the safety of its products, the FDA also has the power to intervene when necessary to protect the public but does not generally require pre-market approval or testing. Companies are required to place a warning note on their products if they have not been tested. Experts in cosmetic ingredient reviews also play a role in monitoring safety through influence on the use of ingredients, but also lack legal authority. Overall the organization has reviewed about 1,200 ingredients and has suggested that several hundred be restricted, but there is no standard or systemic method for reviewing chemicals for safety and a clear definition of what is meant by ‘safety’ so that all chemicals are tested on the same basis.

Veterinary products

The Center for Veterinary Medicine (CVM) is the branch of the FDA which regulates food, food additives, and drugs that are given to animals, including food animals and pets. CVM does not regulate vaccines for animals; these are handled by the United States Department of Agriculture.

CVM's primary focus is on medications that are used in food animals and ensuring that they do not affect the human food supply. The FDA's requirements to prevent the spread of bovine spongiform encephalopathy are also administered by CVM through inspections of feed manufacturers.

Tobacco products

Since the Family Smoking Prevention and Tobacco Control Act became law in 2009, the FDA also has had the authority to regulate tobacco products.

In June 21st 2011, FDA had released Nine Graphic Warning Labels for Cigarette packets.

History

Early history

Origins of federal food and drug regulation

Up until the 20th century, there were few federal laws regulating the contents and sale of domestically produced food and pharmaceuticals, with one exception being the short-lived Vaccine Act of 1813. A patchwork of state laws provided varying degrees of protection against unethical sales practices, such as misrepresenting the ingredients of food products or therapeutic substances. The history of the FDA can be traced to the latter part of the 19th century and the U.S. Department of Agriculture's Division of Chemistry (later Bureau of Chemistry). Under Harvey Washington Wiley, appointed chief chemist in 1883, the Division began conducting research into the adulteration and misbranding of food and drugs on the American market. Although they had no regulatory powers, the Division published its findings from 1887 to 1902 in a ten-part series entitled ''Foods and Food Adulterants''. Wiley used these findings, and alliances with diverse organizations such as state regulators, the General Federation of Women's Clubs, and national associations of physicians and pharmacists, to lobby for a new federal law to set uniform standards for food and drugs to enter into interstate commerce. Wiley's advocacy came at a time when the public had become aroused to hazards in the marketplace by muckraking journalists like Upton Sinclair, and became part of a general trend for increased federal regulations in matters pertinent to public safety during the Progressive Era. The 1902 Biologics Control Act was put in place after diphtheria antitoxin was collected from a horse named Jim who contracted tetanus, resulting in several deaths.

The 1906 Food and Drug Act and creation of the FDA

In June 1906, President Theodore Roosevelt signed into law the Food and Drug Act, also known as the "Wiley Act" after its chief advocate. The Act prohibited, under penalty of seizure of goods, the interstate transport of food which had been "adulterated", with that term referring to the addition of fillers of reduced "quality or strength", coloring to conceal "damage or inferiority," formulation with additives "injurious to health," or the use of "filthy, decomposed, or putrid" substances. The act applied similar penalties to the interstate marketing of "adulterated" drugs, in which the "standard of strength, quality, or purity" of the active ingredient was not either stated clearly on the label or listed in the ''United States Pharmacopoeia'' or the ''National Formulary''. The act also banned "misbranding" of food and drugs. The responsibility for examining food and drugs for such "adulteration" or "misbranding" was given to Wiley's USDA Bureau of Chemistry.

Wiley used these new regulatory powers to pursue an aggressive campaign against the manufacturers of foods with chemical additives, but the Chemistry Bureau's authority was soon checked by judicial decisions, as well as by the creation of the Board of Food and Drug Inspection and the Referee Board of Consulting Scientific Experts as separate organizations within the USDA in 1907 and 1908 respectively. A 1911 Supreme Court decision ruled that the 1906 act did not apply to false claims of therapeutic efficacy, in response to which a 1912 amendment added "false and fraudulent" claims of "curative or therapeutic effect" to the Act's definition of "misbranded." However, these powers continued to be narrowly defined by the courts, which set high standards for proof of fraudulent intent. In 1927, the Bureau of Chemistry's regulatory powers were reorganized under a new USDA body, the Food, Drug, and Insecticide organization. This name was shortened to the Food and Drug Administration (FDA) three years later.

The 1938 Food, Drug, and Cosmetic Act

By the 1930s, muckraking journalists, consumer protection organizations, and federal regulators began mounting a campaign for stronger regulatory authority by publicizing a list of injurious products which had been ruled permissible under the 1906 law, including radioactive beverages, cosmetics which caused blindness, and worthless "cures" for diabetes and tuberculosis. The resulting proposed law was unable to get through the Congress of the United States for five years, but was rapidly enacted into law following the public outcry over the 1937 Elixir Sulfanilamide tragedy, in which over 100 people died after using a drug formulated with a toxic, untested solvent. The only way that the FDA could even seize the product was due to a misbranding problem: an "Elixir" was defined as a medication dissolved in ethanol, not the diethylene glycol used in the Elixir Sulfanilamide.

President Franklin Delano Roosevelt signed the new Food, Drug, and Cosmetic Act (FD&C; Act) into law on June 24, 1938. The new law significantly increased federal regulatory authority over drugs by mandating a pre-market review of the safety of all new drugs, as well as banning false therapeutic claims in drug labeling without requiring that the FDA prove fraudulent intent. The law also authorized factory inspections and expanded enforcement powers, set new regulatory standards for foods, and brought cosmetics and therapeutic devices under federal regulatory authority. This law, though extensively amended in subsequent years, remains the central foundation of FDA regulatory authority to the present day.

Regulation of human drugs and medical devices after 1938

Early FD&C; Act amendments: 1938-1958

Soon after passage of the 1938 Act, the FDA began to designate certain drugs as safe for use only under the supervision of a medical professional, and the category of "prescription-only" drugs was securely codified into law by the 1951 Durham-Humphrey Amendment. While pre-market testing of drug efficacy was not authorized under the 1938 FD&C; Act, subsequent amendments such as the Insulin Amendment and Penicillin Amendment did mandate potency testing for formulations of specific lifesaving pharmaceuticals. The FDA began enforcing its new powers against drug manufacturers who could not substantiate the efficacy claims made for their drugs, and the United States Court of Appeals for the Ninth Circuit ruling in ''Alberty Food Products Co. v. United States'' (1950) found that drug manufacturers could not evade the "false therapeutic claims" provision of the 1938 act by simply omitting the intended use of a drug from the drug's label. These developments confirmed extensive powers for the FDA to enforce post-marketing recalls of ineffective drugs. Much of the FDA's regulatory attentions in this era were directed towards abuse of amphetamines and barbiturates, but the agency also reviewed some 13,000 new drug applications between 1938 and 1962. While the science of toxicology was in its infancy at the start of this era, rapid advances in experimental assays for food additive and drug safety testing were made during this period by FDA regulators and others.

Expansion of premarket approval process: 1959-1985

In 1959, Senator Estes Kefauver began holding congressional hearings into concerns about pharmaceutical industry practices, such as the perceived high cost and uncertain efficacy of many drugs promoted by manufacturers. There was significant opposition, however, to calls for a new law expanding the FDA's authority. This climate was rapidly changed by the thalidomide tragedy, in which thousands of European babies were born deformed after their mothers took that drug - marketed for treatment of nausea - during their pregnancies. Thalidomide had not been approved for use in the U.S. due to the concerns of an FDA reviewer, Frances Oldham Kelsey, about thyroid toxicity. However, thousands of "trial samples" had been sent to American doctors during the "clinical investigation" phase of the drug's development, which at the time was entirely unregulated by the FDA. Individual members of Congress cited the thalidomide incident in lending their support to expansion of FDA authority.

The 1962 Kefauver-Harris Amendment to the FD&C; act represented a "revolution" in FDA regulatory authority. The most important change was the requirement that all new drug applications demonstrate "substantial evidence" of the drug's efficacy for a marketed indication, in addition to the existing requirement for pre-marketing demonstration of safety. This marked the start of the FDA approval process in its modern form. Drugs approved between 1938 and 1962 were also subject to FDA review of their efficacy, and to potential withdrawal from the market. Other important provisions of the 1962 amendments included the requirement that drug companies use the "established" or "generic" name of a drug along with the trade name, the restriction of drug advertising to FDA-approved indications, and expansion of FDA powers to inspect drug manufacturing facilities.

These reforms had the effect of increasing the time required to bring a drug to market. In the mid-1970s, 13 of the 14 drugs the FDA saw as most important to approve were on the market in other countries before the United States.

FDA reforms in the AIDS era

Concerns about the length of the drug approval process were brought to the fore early in the AIDS epidemic. In the mid- and late 1980s, ACT-UP and other HIV activist organizations accused the FDA of unnecessarily delaying the approval of medications to fight HIV and opportunistic infections, and staged large protests, such as a confrontational October 11, 1988 action at the FDA campus which resulted in nearly 180 arrests. In August 1990, Dr. Louis Lasagna, then chairman of a presidential advisory panel on drug approval, estimated that thousands of lives were lost each year due to delays in approval and marketing of drugs for cancer and AIDS.

Partly in response to these criticisms, the FDA issued new rules to expedite approval of drugs for life threatening diseases, and expanded pre-approval access to drugs for patients with limited treatment options. The first of these new rules was the "IND exemption" or "treatment IND" rule, which allowed expanded access to a drug undergoing phase II or III trials (or in extraordinary cases even earlier) if it potentially represented a safer or better alternative to treatments currently available for terminal or serious illness. A second new rule, the "parallel track policy", allowed a drug company to set up a mechanism for access to a new potentially lifesaving drug by patients who for various reasons would be unable to participate in ongoing clinical trials. The "parallel track" designation could be made at the time of IND submission. The accelerated approval rules were further expanded and codified in 1992.

All of the initial drugs approved for the treatment of HIV/AIDS were approved through accelerated approval mechanisms. For example, a "treatment IND" was issued for the first HIV drug, AZT, in 1985, and approval was granted just two years later in 1987. Three of the first five drugs targeting HIV were approved in the United States before they were approved in any other country.

Challenges to FDA authority by states

In two instances, state governments have sought to legalize drugs which have not been approved by the FDA. Because federal law passed pursuant to Constitutional authority overrules conflicting state laws, federal authorities still claim the authority to seize, arrest, and prosecute for possession and sales of these substances, even in states where they are legal under state law.

The first wave was the legalization by 27 states of laetrile in the late 1970s. This drug was used as a treatment for cancer, but scientific studies both before and after this legislative trend found it to be ineffective. Federal law enforcement prevented interstate shipment, making the drug infeasible to manufacture and sell. Further studies based on a Mexican formulation also showed no effectiveness in treating cancer, but did find that some patients experienced symptoms of cyanide poisoning. Though the political movement died out in the 1980s, FDA enforcement actions against laetrile purveyors continued into the 2000s.

The second wave concerned medical marijuana in the 1990s and 2000s. Though Virginia passed a law with limited effect in 1979, a more widespread trend began in California in 1996. The Obama Administration de-prioritized enforcement of federal law against patients using the drug in compliance with state law, resulting in a de facto legalization. Recreational marijuana remains illegal (but not necessarily criminal) in all states and at the federal level, as of 2009.

Recent and ongoing reforms

Critical Path Initiative

The Critical Path Initiative is FDA's effort to stimulate and facilitate a national effort to modernize the sciences through which FDA-regulated products are developed, evaluated, and manufactured. The Initiative was launched in March 2004, with the release of a report entitled Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products.

Patients' rights to access unapproved drugs

A 2006 court case, Abigail Alliance v. von Eschenbach, would have forced radical changes in FDA regulation of unapproved drugs. The Abigail Alliance argued that the FDA must license drugs for use by terminally ill patients with "desperate diagnoses," after they have completed Phase I testing. The case won an initial appeal in May 2006, but that decision was reversed by a March 2007 rehearing. The US Supreme Court declined to hear the case, and the final decision denied the existence of a right to unapproved medications.

Critics of the FDA's regulatory power argue that the FDA takes too long to approve drugs that might ease pain and human suffering faster if brought to market sooner. The AIDS crisis created some political efforts to streamline the approval process. However, these limited reforms were targeted for AIDS drugs, not for the broader market. This has led to the call for more robust and enduring reforms that would allow patients, under the care of their doctors, access to drugs that have passed the first round of clinical trials.

Post-marketing drug safety monitoring

The widely publicized recall of Vioxx, a non-steroidal anti-inflammatory drug now estimated to have contributed to fatal heart attacks in thousands of Americans, played a strong role in driving a new wave of safety reforms at both the FDA rulemaking and statutory levels. Vioxx was approved by the FDA in 1999, and was initially hoped to be safer than previous NSAIDs, due to its reduced risk of intestinal tract bleeding. However, a number of pre- and post-marketing studies suggested that Vioxx might increase the risk of myocardial infarction, and this was conclusively demonstrated by results from the APPROVe trial in 2004. Faced with numerous lawsuits, the manufacturer voluntarily withdrew it from the market. The example of Vioxx has been prominent in an ongoing debate over whether new drugs should be evaluated on the basis of their absolute safety, or their safety relative to existing treatments for a given condition. In the wake of the Vioxx recall, there were widespread calls by major newspapers, medical journals, consumer advocacy organizations, lawmakers, and FDA officials for reforms in the FDA's procedures for pre- and post- market drug safety regulation.

In 2006, a congressionally requested committee was appointed by the Institute of Medicine to review pharmaceutical safety regulation in the U.S. and to issue recommendations for improvements. The committee was composed of 16 experts, including leaders in clinical medicinemedical research, economics, biostatistics, law, public policy, public health, and the allied health professions, as well as current and former executives from the pharmaceutical, hospital, and health insurance industries. The authors found major deficiencies in the current FDA system for ensuring the safety of drugs on the American market. Overall, the authors called for an increase in the regulatory powers, funding, and independence of the FDA. Some of the committee’s recommendations have been incorporated into drafts of the PDUFA IV bill which was signed into law in 2007.

Pediatric drug testing

Prior to the 1990s, only 20% of all drugs prescribed for children in the United States were tested for safety or efficacy in a pediatric population. This became a major concern of pediatricians as evidence accumulated that the physiological response of children to many drugs differed significantly from those drugs' effects on adults. There were several reasons that not many medical trials were done with children. For many drugs, children represented such a small proportion of the potential market, that drug manufacturers did not see such testing as cost-effective. Also, because children were thought to be ethically restricted in their ability to give informed consent, there were increased governmental and institutional hurdles to approval of these clinical trials, as well as greater concerns about legal liability. Thus, for decades, most medicines prescribed to children in the U.S. were done so in a non-FDA-approved, "off-label" manner, with dosages "extrapolated" from adult data through body weight and body-surface-area calculations.

An initial attempt by the FDA to address this issue was the 1994 FDA Final Rule on Pediatric Labeling and Extrapolation, which allowed manufacturers to add pediatric labeling information, but required drugs which had not been tested for pediatric safety and efficacy to bear a disclaimer to that effect. However, this rule failed to motivate many drug companies to conduct additional pediatric drug trials. In 1997, the FDA proposed a rule to require pediatric drug trials from the sponsors of New Drug Applications. However, this new rule was successfully preempted in federal court as exceeding the FDA's statutory authority. While this debate was unfolding, Congress used the 1997 Food and Drug Administration Modernization Act to pass incentives which gave pharmaceutical manufacturers a six-month patent term extension on new drugs submitted with pediatric trial data. The act reauthorizing these provisions, the 2002 Best Pharmaceuticals for Children Act, allowed the FDA to request NIH-sponsored testing for pediatric drug testing, although these requests are subject to NIH funding constraints. Most recently, in the Pediatric Research Equity Act of 2003, Congress codified the FDA's authority to mandate manufacturer-sponsored pediatric drug trials for certain drugs as a "last resort" if incentives and publicly funded mechanisms proved inadequate.

Rules for generic biologics

Since the 1990s, many successful new drugs for the treatment of cancer, autoimmune diseases, and other conditions have been protein-based biotechnology drugs, regulated by the Center for Biologics Evaluation and Research. Many of these drugs are extremely expensive; for example, the anti-cancer drug Avastin costs $55,000 for a year of treatment, while the enzyme replacement therapy drug Cerezyme costs $200,000 per year, and must be taken by Gaucher's Disease patients for life. Biotechnology drugs do not have the simple, readily verifiable chemical structures of conventional drugs, and are produced through complex, often proprietary techniques, such as transgenic mammalian cell cultures. Because of these complexities, the 1984 Hatch-Waxman Act did not include biologics in the Abbreviated New Drug Application (ANDA) process, essentially precluding the possibility of generic drug competition for biotechnology drugs. In February 2007, identical bills were introduced into the House to create an ANDA process for the approval of generic biologics, but were not passed.

Criticism

The FDA currently has regulatory oversight over a large array of products that affect the health and life of American citizens. As a result, the FDA's powers and decisions are carefully monitored by several governmental and non-governmental organizations. A $1.8 million 2006 Institute of Medicine report on pharmaceutical regulation in the U.S. found major deficiencies in the current FDA system for ensuring the safety of drugs on the American market. Overall, the authors called for an increase in the regulatory powers, funding, and independence of the FDA.

Nine FDA scientists appealed to then president-elect Barack Obama over pressures from management, experienced during the George W. Bush presidency, to manipulate data, including in relation to the review process for medical devices. Characterized as "corrupted and distorted by current FDA managers, thereby placing the American people at risk," these concerns were also highlighted in the 2006 report on the agency as well.

The FDA has also been criticized from the opposite viewpoint, as being too tough on industry. According to an analysis published on the website of the libertarian Mercatus Center as well as published statements by economists, medical practitioners, and concerned consumers, many feel the FDA oversteps its regulatory powers and undermines small business and small farms in favor of large corporations. Three of the FDA restrictions under analysis are the permitting of new drugs and devices, the control of manufacturer speech, and the imposition of prescription requirements. The authors argue that in the increasingly complex and diverse food marketplace, the FDA is not equipped to adequately regulate or inspect food.

However, in an indicator that the FDA may be too lax in their approval process, particularly for medical devices, a 2011 study by Dr. Diana Zuckerman and Paul Brown of the National Research Center for Women and Families, and Dr. Steven Nissen of the Cleveland Clinic, published in the Archives of Internal Medicine, showed that most medical devices recalled in the last five years for “serious health problems or death” had been previously approved by the FDA using the less stringent, and cheaper, 510(k) process. In a few cases the devices had been deemed so low-risk that they did not need FDA regulation. Of the 113 devices recalled, 35 were for cardiovascular health purposes.

In 1956 the FDA had moved for the burning of William Reich's books and research materials, which is seen as arguably one of the worst examples of censorship in U.S. history.

Also the testing process of the TAVI aortic valve replacement device, in use in Europe since 2007 and still clinical trials in the United States, has left patients without an alternative to open heart surgery, which is too risky for many elderly patients.

Regulation of living organisms

With acceptance of premarket notification 510(k) k033391 in January 2004, the FDA granted Dr. Ronald Sherman permission to produce and market medical maggots for use in humans or other animals as a prescription medical device. Medical maggots represent the first living organism allowed by the Food and Drug Administration for production and marketing as a prescription medical device.

In June 2004, the FDA cleared ''Hirudo medicinalis'' (medicinal leeches) as the second living organism to be used as a medical devices.

See also

''100,000,000 Guinea Pigs: Dangers in Everyday Foods, Drugs, and Cosmetics'' (book)

Criticism of the Food and Drug Administration

Drug Efficacy Study Implementation

European Medicines Agency

FDA Food Safety Modernization Act

Food Administration

Food and Drug Administration Amendments Act of 2007

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)

Inverse benefit law

Investigational Device Exemption

Kefauver Harris Amendment

Medicines and Healthcare products Regulatory Agency (UK)

Pharmaceutical company

The Food Defect Action Levels, an FDA publication

References

Further reading

Michael Givel (December 2005) ''Philip Morris’ FDA Gambit: Good for Public Health?'' Journal of Public Health Policy (26): pp. 450–468.

Philip J. Hilts. ''Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation.'' New York: Alfred E. Knopf, 2003. ISBN 0-375-40466-X

Thomas J. Moore. ''Prescription for Disaster: The Hidden Dangers in Your Medicine Cabinet.'' New York: Simon & Schuster, 1998. ISBN 0-684-82998-3.

Bartley Madden (July 2010) ''Free To Choose Medicine: How Faster Access to New Drugs Would Save Countless Lives and End Needless Suffering'' Chicago: The Heartland Institute, 2010. ISBN 978-1-934791-32-5

External links

Food & Drug Administration homepage

Strategic Plan (in XML) - from StratML

Biologics Centennial: 100 Years of Biologics Regulation from the Food and Drug Administration Home Page U.S. FDA CDER Home Page the Center for Drug Evaluation and Research CBER Center for Biologics Evaluation and Research, FDA

Past FDA Commissioners

Agency Presentations

Category:United States Public Health Service Category:United States Department of Health and Human Services agencies Category:Society-related timelines Category:National agencies for drug regulation Category:Regulators of biotechnology products Category:Food safety organizations Category:Government agencies established in 1906 Category:1906 establishments in the United States Category:Pharmacology Category:Clinical pharmacologists Category:Clinical pharmacology Category:Therapeutics Category:Article Feedback Pilot

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A pharmaceutical drug, also referred to as medicine, medication or medicament, can be loosely defined as any chemical substance intended for use in the medical diagnosis, cure, treatment, or prevention of disease.

Classification

Medications can be classified in various ways, such as by chemical properties, mode or route of administration, biological system affected, or therapeutic effects. An elaborate and widely used classification system is the Anatomical Therapeutic Chemical Classification System (ATC system). The World Health Organization keeps a list of essential medicines.

A sampling of classes of medicine includes: # Trentyxicyls: reducing headache (sexual appetite/erectile disfunction) # Antipyretics: reducing fever (pyrexia/pyresis) # Analgesics: reducing pain (painkillers) # Antimalarial drugs: treating malaria # Antibiotics: inhibiting germ growth # Antiseptics: prevention of germ growth near burns, cuts and wounds

Types of medications (type of pharmacotherapy)

For the gastrointestinal tract (digestive system)

Upper digestive tract: antacids, reflux suppressants, antiflatulents, antidopaminergics, proton pump inhibitors (PPIs), H₂-receptor antagonists, cytoprotectants, prostaglandin analogues

Lower digestive tract: laxatives, antispasmodics, antidiarrhoeals, bile acid sequestrants, opioid

For the cardiovascular system

General: β-receptor blockers ("beta blockers"), calcium channel blockers, diuretics, cardiac glycosides, antiarrhythmics, nitrate, antianginals, vasoconstrictors, vasodilators, peripheral activators

Affecting blood pressure (antihypertensive drugs): ACE inhibitors, angiotensin receptor blockers, α blockers, calcium channel blockers

Coagulation: anticoagulants, heparin, antiplatelet drugs, fibrinolytics, anti-hemophilic factors, haemostatic drugs

Atherosclerosis/cholesterol inhibitors: hypolipidaemic agents, statins.

For the central nervous system

Drugs affecting the central nervous system include: hypnotics, anaesthetics, antipsychotics, antidepressants (including tricyclic antidepressants, monoamine oxidase inhibitors, lithium salts, and selective serotonin reuptake inhibitors (SSRIs)), antiemetics, anticonvulsants/antiepileptics, anxiolytics, barbiturates, movement disorder (e.g., Parkinson's disease) drugs, stimulants (including amphetamines), benzodiazepines, cyclopyrrolones, dopamine antagonists, antihistamines, cholinergics, anticholinergics, emetics, cannabinoids, and 5-HT (serotonin) antagonists.

For pain & consciousness (analgesic drugs)

The main classes of painkillers are NSAIDs, opioids and various orphans such as paracetamol, tricyclic antidepressants and anticonvulsants.

For musculo-skeletal disorders

The main categories of drugs for musculoskeletal disorders are: NSAIDs (including COX-2 selective inhibitors), muscle relaxants, neuromuscular drugs, and anticholinesterases.

For the eye

General: adrenergic neurone blocker, astringent, ocular lubricant

Diagnostic: topical anesthetics, sympathomimetics, parasympatholytics, mydriatics, cycloplegics

Anti-bacterial: antibiotics, topical antibiotics, sulfa drugs, aminoglycosides, fluoroquinolones

Antiviral drug:

Anti-fungal: imidazoles, polyenes

Anti-inflammatory: NSAIDs, corticosteroids

Anti-allergy: mast cell inhibitors

Anti-glaucoma: adrenergic agonists, beta-blockers, carbonic anhydrase inhibitors/hyperosmotics, cholinergics, miotics, parasympathomimetics, prostaglandin agonists/prostaglandin inhibitors. nitroglycerin

For the ear, nose and oropharynx

sympathomimetics, antihistamines, anticholinergics, NSAIDs, steroids, antiseptics, local anesthetics, antifungals, cerumenolyti

For the respiratory system

bronchodilators, NSAIDs, anti-allergics, antitussives, mucolytics, decongestantscorticosteroids, Beta2-adrenergic agonists, anticholinergics, steroids

For endocrine problems

androgens, antiandrogens, gonadotropin, corticosteroids, human growth hormone, insulin, antidiabetics (sulfonylureas, biguanides/metformin, thiazolidinediones, insulin), thyroid hormones, antithyroid drugs, calcitonin, diphosponate, vasopressin analogues

For the reproductive system or urinary system

antifungal, alkalising agents, quinolones, antibiotics, cholinergics, anticholinergics, anticholinesterases, antispasmodics, 5-alpha reductase inhibitor, selective alpha-1 blockers, sildenafils, fertility medications

For contraception

Hormonal contraception

Ormeloxifene

Spermicide

For obstetrics and gynecology

NSAIDs, anticholinergics, haemostatic drugs, antifibrinolytics, Hormone Replacement Therapy (HRT), bone regulators, beta-receptor agonists, follicle stimulating hormone, luteinising hormone, LHRH gamolenic acid, gonadotropin release inhibitor, progestogen, dopamine agonists, oestrogen, prostaglandins, gonadorelin, clomiphene, tamoxifen, Diethylstilbestrol

For the skin

emollients, anti-pruritics, antifungals, disinfectants, scabicides, pediculicides, tar products, vitamin A derivatives, vitamin D analogues, keratolytics, abrasives, systemic antibiotics, topical antibiotics, hormones, desloughing agents, exudate absorbents, fibrinolytics, proteolytics, sunscreens, antiperspirants, corticosteroids

For infections and infestations

antibiotics, antifungals, antileprotics, antituberculous drugs, antimalarials, anthelmintics, amoebicides, antivirals, antiprotozoals

For the immune system

vaccines, immunoglobulins, immunosuppressants, interferons, monoclonal antibodies

For allergic disorders

anti-allergics, antihistamines, NSAIDs

For nutrition

tonics, iron preparations, electrolytes, parenteral nutritional supplements, vitamins, anti-obesity drugs, anabolic drugs, haematopoietic drugs, food product drugs

For neoplastic disorders

cytotoxic drugs, therapeutic antibodies, sex hormones, aromatase inhibitors, somatostatin inhibitors, recombinant interleukins, G-CSF, erythropoietin

For diagnostics

contrast media

For euthanasia

An euthanaticum is used for euthanasia and physician-assisted suicide.

Euthanasia is not permitted by law in many countries, and consequently medicines will not be licensed for this use in those countries.

== Administration == Administration is the delivery of a pharmaceutical drug to a patient.

It can be performed in various dosage forms such as pills, tablets, or capsules.

There are also many variations in the routes of administration, including intravenous (into the blood through a vein) and oral administration (through the mouth).

They can be administered all at once as a bolus, at frequent intervals or continuously. Frequencies are often abbreviated from Latin, such as ''every 8 hours'' reading Q8H from ''Quaque VIII Hora''.

Legal considerations

Depending upon the jurisdiction, medications may be divided into over-the-counter drugs (OTC) which may be available without special restrictions, and prescription only medicine (POM), which must be prescribed by a licensed medical practitioner. The precise distinction between OTC and prescription depends on the legal jurisdiction. A third category, behind-the-counter medications (BTMs), is implemented in some jurisdictions. BTMs do not require a prescription, but must be kept in the dispensary, not visible to the public, and only be sold by a pharmacist or pharmacy technician. Doctors may also prescribe prescription drugs for off-label use - purposes which the drugs were not originally approved for by the regulatory agency. The Classification of Pharmaco-Therapeutic Referrals helps guide the referral process between pharmacists and doctors.

The International Narcotics Control Board of the United Nations imposes a world law of prohibition of certain medications. They publish a lengthy list of chemicals and plants whose trade and consumption (where applicable) is forbidden. OTC medications are sold without restriction as they are considered safe enough that most people will not hurt themselves accidentally by taking it as instructed. Many countries, such as the United Kingdom have a third category of pharmacy medicines which can only be sold in registered pharmacies, by or under the supervision of a pharmacist.

For patented medications, countries may have certain mandatory licensing programs which compel, in certain situations, a medication's owner to contract with other agents to manufacture the drug. Such programs may deal with the contingency of a lack of medication in the event of a serious epidemic of disease, or may be part of efforts to ensure that disease treating drugs, such as AIDS drugs, are available to countries which cannot afford the drug owner's price.

Prescription practice

Drugs which are prescription only are regulated as such because they can impose adverse effects and should not be used unless necessary. Medical guidelines and clinical trials required for approval are used to help inform doctors' prescription of these drugs, but errors can happen. Reasons to not prescribe drugs such as interactions or side effects are called contraindications.

Errors include overprescription and polypharmacy, misprescription, contraindication and lack of detail in dosage and administrations instructions. In 2000 the definition of a prescription error was studied using a Delphi method conference; the conference was motivated by ambiguity in the what a prescription error and a need to use a uniform definition in studies.

Development

Drug development is the process by which a drug is created. Drugs can be extracted from natural products (pharmacognosy) or synthesized through chemical processes. The drug's active ingredient will be combined with a "vehicle" such as a capsule, cream, or liquid which will be administered through a particular route of administration. Child-resistant packaging will likely be used in the ultimate package sold to the consumer.

==Blockbuster drug== A blockbuster drug is a drug generating more than $1 billion of revenue for its owner each year.

A report from URCH Publishing estimated that about one third of the pharma market by value is accounted for by blockbusters. About 125 products are blockbusters. The top seller was Lipitor, a cholesterol-lowering medication marketed by Pfizer with sales of $12.5 billion.

In 2009 there were a total of seven new blockbuster drugs, with combined sales of $9.8 billion.

Beyond this purely arbitrary financial consideration,

::"In the pharmaceutical industry, a blockbuster drug is one that achieves acceptance by prescribing physicians as a therapeutic standard for, most commonly, a highly prevalent chronic (rather than acute) condition. Patients often take the medicines for long periods."

Leading blockbuster drugs

!Drug	!Trade name	!Company	Sales (billion $), year
Atorvastatin	Lipitor	Pfizer	12 (2007) >
Clopidogrel	Plavix	Bristol-Myers Squibb and Sanofi-Aventis	5.9 (2005)
Enoxaparin	Lovenox or Clexane	Sanofi-Aventis
Celecoxib	Celebrex	Pfizer	2.3 (2007)
Omeprazole	Losec/Prilosec	AstraZeneca	2.6 (2004)
Esomeprazole	Nexium	AstraZeneca	3.3 (2003)
Fexofenadine	Telfast/Allegra	Aventis	1.87 (2004)
Quetiapine	Seroquel	AstraZeneca	1.5 (2003)
Metoprolol	Seloken/Toprol	AstraZeneca	1.3 (2003)
Budesonide	Pulmicort/Rhinocort	AstraZeneca	1.3 (2003) (plus some fraction of the $0.6bn sales of Symbicort)

Environmental impact

Since the 1990s water contamination by pharmaceuticals has been an environmental issue of concern. Most pharmaceuticals are deposited in the environment through human consumption and excretion, and are often filtered ineffectively by wastewater treatment plants which are not designed to manage them. Once in the water they can have diverse, subtle effects on organisms, although research is limited. Pharmaceuticals may also be deposited in the environment through improper disposal, runoff from sludge fertilizer and reclaimed wastewater irrigation, and leaky sewage. In 2009 an investigative report by Associated Press concluded that U.S. manufacturers had legally released 271 million pounds of drugs into the environment, 92% of which was the antiseptics phenol and hydrogen peroxide. It could not distinguish between drugs released by manufacturers as opposed to the pharmaceutical industry. It also found that an estimated 250 million pounds of pharmaceuticals and contaminated packaging were discarded by hospitals and long-term care facilities.

Pharmacoenvironmentology is a branch of pharmacology and a form of pharmacovigilance which deals entry of chemicals or drugs into the environment after elimination from humans and animals post-therapy. It deals specifically with those pharmacological agents that have impact on the environment via elimination through living organisms subsequent to pharmacotherapy, while Ecopharmacology is concerned with the entry of chemicals or drugs into the environment through any route and at any concentration disturbing the balance of ecology (ecosystem), as a consequence. Ecopharmacology is a broad term that includes studies of “PPCPs” irrespective of doses and route of entry into environment.

History

Ancient pharmacology

Using plants and plant substances to treat all kinds of diseases and medical conditions is believed to date back to prehistoric medicine.

The Kahun Gynaecological Papyrus, the oldest known medical text of any kind, dates to about 1800 BCE and represents the first documented use of any kind of medication. It and other medical papyri describe Ancient Egyptian medical practices, such as using honey to treat infections.

Ancient Babylonian medicine demonstrate the use of prescriptions in the first half of the 2nd millennium BC. Medicinal creams and pills were employed as treatments.

On the Indian subcontinent, the Atharvaveda, a sacred text of Hinduism whose core dates from the 2nd millennium BCE, although the hymns recorded in it are believed to be older, is the first Indic text dealing with medicine. It describes plant-based medications to counter diseases. The earliest foundations of ayurveda were built on a synthesis of selected ancient herbal practices, together with a massive addition of theoretical conceptualizations, new nosologies and new therapies dating from about 400 BCE onwards. The student of Āyurveda was expected to know ten arts that were indispensable in the preparation and application of his medicines: distillation, operative skills, cooking, horticulture, metallurgy, sugar manufacture, pharmacy, analysis and separation of minerals, compounding of metals, and preparation of alkalis.

The Hippocratic Oath for physicians, attributed to 5th century BCE Greece, refers to the existence of "deadly drugs", and ancient Greek physicians imported medications from Egypt and elsewhere.

The first drugstores were created in Baghdad in the 8th century CE. The injection syringe was invented by Ammar ibn Ali al-Mawsili in 9th century Iraq. Al-Kindi's 9th century CE book, ''De Gradibus'', developed a mathematical scale to quantify the strength of drugs.

''The Canon of Medicine'' by Ibn Sina (Avicenna), who is considered the father of modern medicine, reported 800 tested drugs at the time of its completion in 1025 CE. Ibn Sina's contributions include the separation of medicine from pharmacology, which was important to the development of the pharmaceutical sciences. Islamic medicine knew of at least 2,000 medicinal and chemical substances.

Medieval pharmacology

Medieval medicine saw advances in surgery, but few truly effective drugs existed, beyond opium and quinine. Folklore cures and potentially poisonous metal-based compounds were popular treatments. Theodoric Borgognoni, (1205–1296), one of the most significant surgeons of the medieval period, responsible for introducing and promoting important surgical advances including basic antiseptic practice and the use of anaesthetics. Garcia de Orta described some herbal treatments that were used.

Modern pharmacology

For most of the 19th century, drugs were not highly effective, leading Oliver Wendell Holmes, Sr. to famously comment in 1842 that "if all medicines in the world were thrown into the sea, it would be all the better for mankind and all the worse for the fishes".

During the First World War, Alexis Carrel and Henry Dakin developed the Carrel-Dakin method of treating wounds with an irrigation, Dakin's solution, a germicide which helped prevent gangrene.

In the inter-war period, the first anti-bacterial agents such as the sulpha antibiotics were developed. The Second World War saw the introduction of widespread and effective antimicrobial therapy with the development and mass production of penicillin antibiotics, made possible by the pressures of the war and the collaboration of British scientists with the American pharmaceutical industry.

Medicines commonly used by the late 1920s included aspirin, codeine, and morphine for pain; digitalis, nitroglycerin, and quinine for heart disorders, and insulin for diabetes. Other drugs included antitoxins, a few biological vaccines, and a few synthetic drugs. In the 1930s antibiotics emerged: first sulfa drugs, then penicillin and other antibiotics. Drugs increasingly became "the center of medical practice". In the 1950s other drugs emerged including corticosteroids for inflammation, rauwolfia alkloids as tranqulizers and antihypertensives, antihistamines for nasal allergies, xanthines for asthma, and typical antipsychotics for psychosis. As of 2008, thousands of approved drugs have been developed. Increasingly, biotechnology is used to discover biopharmaceuticals. Recently, multi-disciplinary approaches have yielded a wealth of new data on the development of novel antibiotics and antibacterials and on the use of biological agents for antibacterial therapy.

In the 1950s new psychiatric drugs, notably the antipsychotic chlorpromazine, were designed in laboratories and slowly came into preferred use. Although often accepted as an advance in some ways, there was some opposition, due to serious adverse effects such as tardive dyskinesia. Patients often opposed psychiatry and refused or stopped taking the drugs when not subject to psychiatric control.

Governments have been heavily involved in the regulation of drug development and drug sales. In the U.S., the Elixir Sulfanilamide disaster led to the establishment of the Food and Drug Administration, and the 1938 Federal Food, Drug, and Cosmetic Act required manufacturers to file new drugs with the FDA. The 1951 Humphrey-Durham Amendment required certain drugs to be sold by prescription. In 1962 a subsequent amendment required new drugs to be tested for efficacy and safety in clinical trials.

Until the 1970s, drug prices were not a major concern for doctors and patients. As more drugs became prescribed for chronic illnesses, however, costs became burdensome, and by the 1970s nearly every U.S. state required or encouraged the substitution of generic drugs for higher-priced brand names. This also led to the 2006 U.S. law, Medicare Part D, which offers Medicare coverage for drugs.

As of 2008, the United States is the leader in medical research, including pharmaceutical development. U.S. drug prices are among the highest in the world, and drug innovation is correspondingly high. In 2000 U.S. based firms developed 29 of the 75 top-selling drugs; firms from the second-largest market, Japan, developed eight, and the United Kingdom contributed 10. France, which imposes price controls, developed three. Throughout the 1990s outcomes were similar.

See also

References

External links

WHO Model List of Essential Medicines

New Medicines Database | PHRMA

Informations and Leaflets of approved pharmaceutical drugs | Diagnosia

SuperCYP: Database for Drug-Cytochrome- and Drug-Drug-interactions

Category:Pharmacology

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Name	Gregory James Caton
Birth date	April 06, 1956
Death date
Resting place coordinates
Nationality	American
Citizenship	American
Other names	James Carr
Known for	Herbalist, Alternative Medicine Promoter
Education	AA (1975), Los Angeles Valley College
Alma mater	Los Angeles Valley College
Home town	Glendale, California
Callsign	N5OY
Website	Gregcaton.com

Gregory James Caton (b. April 6, 1956) is an American businessman, inventor, manufacturer and promoter of various herbal products, the main one being Cansema which is claimed to cure skin cancer, although the U.S. Food and Drug Administration (FDA) banned it in 2003 as worthless. Caton is the founder of Alpha Omega Labs, a manufacturer of natural health care products, that currently distributs internationally from Guayaquil, Ecuador.

Early life and education

Caton attended Los Angeles Valley College, a community college in the San Fernando Valley, and then served in the US Navy as a cryptologist from 1975 through 1978. Caton has been an avid amateur and short wave radio operator.

First businesses

Caton founded Consumer Express in 1984. which later became Nutrition for Life, a multi level mailorder company (MLM). The firm traded briefly on the NASDAQ stock exchange.

Nutrition for Life entered into a business agreement with Kevin Trudeau After the change of ownership of Consumer Express, Caton authored a book (which was since withdrawn) on his version of the alleged fraud surrounding this transaction. Down-Line News reviewed this work in February 1993 on their website. Caton filed a suit against Kevin Trudeau in the US Fifth District Court of Appeals, in response to a libel suit by Trudeau in 1996 over Caton's aforementioned book.

In January 1996, Kevin Trudeau filed a libel suit against Caton in Illinois state court based on statements Caton made in a book and on an Internet website. Caton removed the action to federal court, but on Trudeau's motion, the action was remanded. Thereafter, Caton failed to respond to Trudeau's claims and the court entered a default and noticed an evidential hearing. On June 5, 1996, after a hearing, the court rendered a default judgment against Caton, awarding Trudeau $5 million in compensatory damages and $5 million in punitive damages.

In November 1996, Caton filed for Chapter 7 bankruptcy in response to the judgment. Shortly afterward, the company was subject to a class action lawsuit filed in Harris County, Texas. Nutrition for Life filed for Chapter 7 bankruptcy on July 8, 2003.

Caton then took up a project to detail the issues associated with multi-level marketing on a site entitled ''MLM Credit Bureau''. He was featured in an online article by Ami Mills on the Metroactive website in 1996 regarding his work.

Lumen Foods, Alpha Omega Labs and Herbologics

Caton started Alpha Omega Labs in 1995 using the pseudonym "James Carr". Alpha Omega Labs became a provider of over 300 alternative health products with 14 distributors around the world, before its closure by the U.S. Food and Drug Administration (FDA) in 2003.

Lumen Foods was featured in an article by the online newspaper World Net Daily, alleging that the firm was under seizure of its accounts due to fraudulent activity. Caton vigorously refuted the claim, which he alleged was related to issues surrounding the Y2K panic.

In early 2000, Lumen Foods reportedly "broke ranks" with the health food industry when it was reported that it would actively include Genetically modified organism (GMO) products in its offerings.

"They have it all wrong", said Lumen Foods' President, Greg Caton. "FDA, USDA, and EPA have all done exhaustive research into their safety and have found nothing that remotely suggests that either the consumer or the environment are at risk from GM seed", he said.

This earned significant attention from non-GMO advocates. Caton spoke at Cornell University's sponsored symposium, Informing the Dialogue about Agricultural Biotechnology, in November 1999. His topic was GMO Controversy & the Whole Foods Industry: Why Wholesale Condemnation of Agricultural Biotechnology Hurts our Most Ingredient-Sensitive Markets Lumen Foods reversed their position later in the year, supposedly from pressure by their customers.

Alpha Omega was the topic of an exposé by ''Business Week'' in their review of the book ''Natural Causes''. The review in ''Business Week'' references the case of Sue Gilliatt, a nurse from Indianapolis who claimed she used Cansema, as well as a product named "H3O" (also sold by Caton) for skin cancer on her nose and that they burned off her nose (in the lawsuit, H3O was primarily blamed). Caton contested Gilliatt's assertions, claiming that due to the individual's use of additional alternative medicine, exclusive attribution of damages from H3O could not be determined. Furthermore, according to Caton, Gilliatt contradicted herself several times in her various court testimonies. Caton even claims that Gilliatt's nose appears to have been surgically removed, citing photographs. The use of escharotics (caustic pastes) such as Cansema to treat skin cancer is "unproven" and can have "serious consequences", according to dermatologists.

Federal conviction

In 2003, United States Federal agents from the joint task force (including U.S. FDA, Bureau of Alcohol, Firearms and Tobacco and local law enforcement) raided Caton's offices, factory and home. As a result of the raid, Caton pled guilty in 2004 and was sentenced to 33 months in prison for weapons possession by a felon and for defrauding customers and violating FDA regulations. Caton had received a previous felony conviction for counterfeiting in 1990.

Caton filed for a writ of habeas corpus based upon ineffective counsel in 2005. This was denied with prejudice by the courts.

Reestablishment of Alpga Omega Labs in Ecuador

On 5 June 2006, after serving his sentence, Greg Caton was released on three years probation with specific restrictions against possession of firearms or manufacture of non-FDA approved materials. Caton and his family relocated to Ecuador in the summer of 2007. Alpha Omega Labs were reopened in June 2008.

Re-arrest and extradition

On 27 October 2007, Caton was found in violation of the terms of his probation. In September 2008, a filing was made with the U.S. patent office in which Caton expressed a fear of arrest for violation of his probation, if he returned to the US.

Caton's probation violation was reported to Interpol, and was placed in their database; it was reported on Interpol website on 30 September 2008. In February 2009, Caton was featured in ''Parade Magazine'''s "On the Run In America" as an Interpol international fugitive.

On 3 December 2009, Caton was arrested at a checkpoint in Ecuador and held in prison. What followed was a complex set of legal manoeuvres involving multiple parties. According to Cathryn Caton, his wife, these manoeuvres included various members of the Ecuadorian judiciary and Police officials. A judicial hearing on the case was scheduled in Guayaquil, Ecuador on 14 December 2009.

Caton is currently imprisoned in the US. He was sentenced sentenced in a Louisiana court in May 2010 to serve the remainder of his probation (24 months) in prison. He filed a motion of appeal on June 23, 2011, under the provision that the court failed to consider sentencing guidelines. This appeal was denied

Patents

Greg Caton submitted a patent application in 2008 for a food preservative

Patent application title: Lower alkyl carboxylic acid moieties as organoleptic stabilizers and preservatives of food and beverages and for preventing oxidative corrosion of metals; Inventors: Gregory James Caton - Agents: WEINGARTEN, SCHURGIN, GAGNEBIN & LEBOVICI LLP - Assignees: Intellectual Concepts, LLC - Origin: BOSTON, MA US IPC8 Class: AA23L33517FI USPC Class: 4263303

Authored works

Caton, G.J.; ''Lumen: Food For A New Age'', Calcasieu Graphics & Pressworks, 1986. ISBN 0-939955-00-8

Caton, Greg; ''MLM Fraud: A Practical Handbook for the Network Marketing Professional'', (self-published), 1990. ISBN 0-939955-03-2

Websites

Altcancer

Lumen Foods

Additional reading

Hurley, Dan, ''Natural Causes: Death, Lies, and Politics in America's Vitamin and Herbal Supplement Industry''. Broadway Publishers (2007) ISBN 0-7679-2042-2

References

External links

Alpha Omega Lab Site

Category:People in alternative medicine Category:Herbalists Category:1956 births Category:Living people