HOME

TheInfoList




The
United States The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country Continental United States, primarily located in North America. It consists of 50 U.S. state, states, a Washington, D.C., ...

United States
Food and Drug Administration (FDA or USFDA) is a federal agency of the
Department of Health and Human Services The United States Department of Health and Human Services (HHS), also known as the Health Department, is a cabinet-level executive branch The executive is the branch of government exercising authority in and holding Moral responsibility, r ...
. The FDA is responsible for protecting and promoting
public health Public health has been defined as "the science and art of preventing disease", prolonging life and improving quality of life Quality of life (QOL) is defined by the World Health Organization The World Health Organization (WHO) is a lis ...

public health
through the control and supervision of
food safety Food safety (or food hygiene) is used as a scientific method/discipline describing handling, preparation, and storage of food in ways that prevent food-borne illness Foodborne illness (also foodborne disease and colloquially referred to as ...
,
tobacco Tobacco is the common name of several plants in the ' of the , and the general term for any product prepared from the of these plants. of tobacco are known, but the chief commercial crop is . The more potent variant is also used in som ...

tobacco
products,
dietary supplement A dietary supplement is a manufactured product intended to supplement one's diet by taking a pill Pill or The Pill may refer to: Drugs * Pill (pharmacy) A tablet is a pharmaceutical A medication (also referred to as medicine, ...
s, prescription and
over-the-counter Over-the-counter (OTC) drugs are medicine Medicine is the Art (skill), art, science, and Praxis (process) , practice of caring for a patient and managing the diagnosis, prognosis, Preventive medicine, prevention, therapy, treatment or Palliat ...
pharmaceutical drug A medication (also called medicament, medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to medical diagnosis, diagnose, cure, therapy, treat, or preventive medicine, prevent disease. Drug therapy (pharmacotherapy) ...
s (medications),
vaccine A vaccine is a biological preparation that provides active acquired immunity to a particular infectious disease. A vaccine typically contains an agent that resembles a disease-causing microorganism and is often made from weakened or killed for ...

vaccine
s,
biopharmaceutical A biopharmaceutical, also known as a biologic(al) medical product, or biologic, is any pharmaceutical drug A medication (also referred to as medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to diagnose, cure, t ...
s,
blood transfusion Blood transfusion is the process of transferring blood product A blood product is any therapeutic substance prepared from human blood. This includes whole blood; blood components; and plasma derivatives. Whole blood is not commonly used in t ...

blood transfusion
s,
medical device A medical device is any device intended to be used for medical purposes. Significant potential for hazard A hazard is a potential source of harm. Substances, events, or circumstances can constitute hazards when their nature would allow them, e ...
s,
electromagnetic radiation In physics Physics is the natural science that studies matter, its Elementary particle, fundamental constituents, its Motion (physics), motion and behavior through Spacetime, space and time, and the related entities of energy and force. ...

electromagnetic radiation
emitting devices (ERED), cosmetics, animal foods & feed and veterinary products. The FDA's primary focus is enforcement of the
Federal Food, Drug, and Cosmetic Act The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by Congress Congresses are formal meetings of the representatives of different countries A country is a distinct terri ...
(FD&C), but the agency also enforces other laws, notably Section 361 of the
Public Health Service Act The Public Health Service Act is a United States federal law The law of the United States comprises many levels of codified and uncodified forms of law, of which the most important is the nation's Constitution of the United States, Constitution ...
, as well as associated regulations. Much of this regulatory-enforcement work is not directly related to food or drugs, but involves such things as regulating
lasers A laser is a device that emits light through a process of optical amplification based on the stimulated emission of electromagnetic radiation. The word "laser" is an acronym for "light amplification by stimulated emission of radiation". Th ...

lasers
,
cellular phones A mobile phone, cellular phone, cell phone, cellphone, handphone, or hand phone, sometimes shortened to simply mobile, cell or just phone, is a portable telephone A telephone is a telecommunication Telecommunication is the tra ...
, and
condoms A condom is a sheath-shaped Barrier contraception, barrier device used during sexual intercourse to reduce the probability of pregnancy or a Sexually transmitted disease, sexually transmitted infection (STI). There are both male and female cond ...

condoms
, as well as control of disease in contexts varying from household
pet A pet, or companion animal, is an animal kept primarily for a person's company or entertainment rather than as a working animal, livestock or a laboratory animal. Popular pets are often considered to have attractive appearances, Animal cognitio ...

pet
s to human sperm donated for use in
assisted reproduction Assisted reproductive technology (ART) includes medical procedures used primarily to address infertility. This subject involves procedures such as in vitro fertilization, intracytoplasmic sperm injection (ICSI), cryopreservation of gametes or embryo ...
. The FDA is led by the
Commissioner of Food and Drugs The United States Commissioner of Food and Drugs is the head of the Food and Drug Administration (FDA), an Government agency, agency of the United States Department of Health and Human Services. The commissioner is appointed by the president of th ...
, appointed by the
President President most commonly refers to: *President (corporate title) A president is a leader of an organization, company, community, club, trade union, university or other group. The relationship between a president and a Chief Executive Officer, chi ...

President
with the
advice and consent Advice and consent is an English phrase frequently used in enacting formulae of bill Bill(s) may refer to: Common meanings * Banknote A banknote (often known as a bill (in the US and Canada), paper money, or simply a note) is a type o ...
of the
Senate The Curia Julia in the Roman Forum ">Roman_Forum.html" ;"title="Curia Julia in the Roman Forum">Curia Julia in the Roman Forum A senate is a deliberative assembly, often the upper house or Debating chamber, chamber of a bicameral legislatu ...
. The Commissioner reports to the
Secretary of Health and Human Services The United States secretary of health and human services is the head of the United States Department of Health and Human Services The United States Department of Health and Human Services (HHS), also known as the Health Department, is a Cabine ...
. Janet Woodcock is the acting commissioner, . The FDA has its
headquarters Headquarters (commonly referred to as HQ) denotes the location where most, if not all, of the important functions of an organization are coordinated. In the United States The United States of America (USA), commonly known as the United St ...

headquarters
in
unincorporatedUnincorporated may refer to: * Unincorporated area, land not governed by a local municipality * Unincorporated entity, a type of organization * Unincorporated territories of the United States, territories under U.S. jurisdiction, to which Congress h ...
White Oak, Maryland. The agency also has 223 field offices and 13
laboratories A laboratory (, ; colloquially lab) is a facility that provides controlled conditions in which scientific Science (from the Latin Latin (, or , ) is a classical language belonging to the Italic languages, Italic branch of the Indo-E ...
located throughout the 50
states State may refer to: Arts, entertainment, and media Literature * ''State Magazine'', a monthly magazine published by the U.S. Department of State * The State (newspaper), ''The State'' (newspaper), a daily newspaper in Columbia, South Carolina, Un ...
, the
United States Virgin Islands The United States Virgin Islands, officially the Virgin Islands of the United States, are a group of Caribbean The Caribbean (, ; es, Caribe; french: Caraïbes; ht, Karayib; also gcf, label=Antillean Creole Antillean Creole (Antillean ...
, and
Puerto Rico Puerto Rico (; abbreviated PR; tnq, Boriken, ''Borinquen''), officially the Commonwealth of Puerto Rico ( es, link=yes, Estado Libre Asociado de Puerto Rico, lit=Free Associated State of Puerto Rico) is a Caribbean The Caribbean (, ; es, ...

Puerto Rico
. In 2008, the FDA began to post employees to foreign countries, including China, India, Costa Rica, Chile, Belgium, and the United Kingdom.


Organizational structure

*
Department of Health and Human Services The United States Department of Health and Human Services (HHS), also known as the Health Department, is a cabinet-level executive branch The executive is the branch of government exercising authority in and holding Moral responsibility, r ...
** Food and Drug Administration *** Office of the Commissioner *** Office of Operations **** Office of Equal Employment Opportunity **** Office of Human Resources **** Office of Finance, Budget and Acquisition **** Office of Information Management and Technology ***** Office of Informatics & Technology Innovation ****** ***** Office of Information Management **** Office of Security Operations **** Office of Facilities Engineering and Mission Support Services ***
Center for Biologics Evaluation and Research The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the U.S. Food and Drug Administration The United States of America (USA), commonly known as the United States (U.S. or US), or America, is a country pri ...
(CBER) ***
Center for Devices and Radiological Health The Center for Devices and Radiological Health (CDRH) is the branch of the United States The United States of America (USA), commonly known as the United States (U.S. or US), or America, is a country Contiguous United States, primarily locat ...
(CDRH) ***
Center for Drug Evaluation and Research The Center for Drug Evaluation and Research (CDER, pronounced "see'-der") is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act. Some biological products are also le ...
(CDER) ***
Center for Food Safety and Applied Nutrition The Center for Food Safety and Applied Nutrition (CFSAN, pronounced sif'-san) is the branch of the United States Food and Drug Administration The United States The United States of America (USA), commonly known as the United States ( ...
(CFSAN) ***
Center for Tobacco ProductsThe Center for Tobacco Products (CTP) was established by the United States Food and Drug Administration The United States The United States of America (USA), commonly known as the United States (U.S. or US), or America, is a country Con ...
(CTP) ***
Center for Veterinary Medicine The Center for Veterinary Medicine (CVM) is a branch of the U.S. Food and Drug Administration (FDA) that regulates the manufacture and distribution of food Food is any substance consumed to provide nutritional support for an organism ...
(CVM) *** Oncology Center of Excellence (OCE) ***
Office of Regulatory Affairs The Office of Global Regulatory Operations and Policy (GO), also known as the Office of Regulatory Affairs (ORA), is the part of the Food and Drug Administration (United States), U.S. Food and Drug Administration (FDA) enforcing the federal laws go ...
*** Office of Clinical Policy and Programs *** Office of External Affairs *** Office of Food Policy and Response *** Office of Minority Health and Health Equity *** Office of Policy, Legislation, and International Affairs *** Office of the Chief Scientist *** Office of Women's Health ***
National Center for Toxicological Research The National Center for Toxicological Research (NCTR) is the branch of the United States Food and Drug Administration The United States The United States of America (USA), commonly known as the United States (U.S. or US), or America, ...
(NCTR)


Location


Headquarters

FDA headquarters facilities are currently located in
Montgomery CountyMontgomery County may refer to: Australia * The former name of Montgomery Land District, Tasmania United Kingdom * The historic county of Montgomeryshire, Wales, also called County of Montgomery United States

* Montgomery County, Alabama * Mon ...
and
Prince George's County ) , demonym = Prince Georgian , ZIP codes = 20607–20774 , area codes = 240, Area codes 240 and 301, 301 , founded date = April 23 , founded year = 1696 , named for = Prince George of Denmark , leader_title = Executive , leader_name ...
, Maryland.


White Oak Federal Research Center

Since 1990, the FDA has had employees and facilities on of the White Oak Federal Research Center in the
White Oak The genus Genus /ˈdʒiː.nəs/ (plural genera /ˈdʒen.ər.ə/) is a taxonomic rank In biological classification In biology, taxonomy () is the scientific study of naming, defining (Circumscription (taxonomy), circumscribing) and cl ...
area of
Silver Spring, Maryland Silver Spring is a census-designated place A census-designated place (CDP) is a Place (United States Census Bureau), concentration of population defined by the United States Census Bureau for statistical purposes only. CDPs have been used in ea ...
.Coordinates of FDA Headquarters at White Oak, Maryland: In 2001, the
General Services Administration The General Services Administration (GSA) is an Independent agencies of the United States government, independent agency of the United States government established in 1949 to help manage and support the basic functioning of federal agencies. G ...
(GSA) began new construction on the campus to consolidate the FDA's 25 existing operations in the
Washington metropolitan area#REDIRECT Washington metropolitan area The Washington metropolitan area (also known as the National Capital Region and colloquially as the DMV for "D.C., Maryland, Virginia") is the metropolitan area centered on Washington, D.C., the capital of ...
, its headquarters in Rockville, and several fragmented office buildings. The first building, the Life Sciences Laboratory, was dedicated and opened with 104 employees in December 2003. As of December 2018, the FDA campus has a population of 10,987 employees housed in approximately of space, divided into ten office and four laboratory buildings. The campus houses the Office of the Commissioner (OC), the Office of Regulatory Affairs (ORA),  the
Center for Drug Evaluation and Research The Center for Drug Evaluation and Research (CDER, pronounced "see'-der") is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act. Some biological products are also le ...
(CDER), the
Center for Devices and Radiological Health The Center for Devices and Radiological Health (CDRH) is the branch of the United States The United States of America (USA), commonly known as the United States (U.S. or US), or America, is a country Contiguous United States, primarily locat ...
(CDRH), the
Center for Biologics Evaluation and Research The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the U.S. Food and Drug Administration The United States of America (USA), commonly known as the United States (U.S. or US), or America, is a country pri ...
(CBER) and offices for the
Center for Veterinary Medicine The Center for Veterinary Medicine (CVM) is a branch of the U.S. Food and Drug Administration (FDA) that regulates the manufacture and distribution of food Food is any substance consumed to provide nutritional support for an organism ...
(CVM). With the passing of the FDA Reauthorization Act of 2017, the FDA is projecting a 64% increase in employees to 18,000 over the next 15 years, and would like to add approximately of office and special use space to their existing facilities. The
National Capital Planning Commission The National Capital Planning Commission (NCPC) is a United States government, U.S. government agency that provides Urban planning, planning guidance for Washington, D.C., and the surrounding National Capital Region. Through its planning policies an ...
approved a new master plan for this expansion in December 2018, and construction is expected to be completed by 2035, dependent on GSA appropriations.


Field locations


Office of Regulatory Affairs

The
Office of Regulatory Affairs The Office of Global Regulatory Operations and Policy (GO), also known as the Office of Regulatory Affairs (ORA), is the part of the Food and Drug Administration (United States), U.S. Food and Drug Administration (FDA) enforcing the federal laws go ...
is considered the agency's "eyes and ears," conducting the vast majority of the FDA's work in the field. Its employees, known as Consumer Safety Officers, or more commonly known simply as investigators, 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 20 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 remote offices that serve a particular geographic area. ORA also includes the Agency's network of regulatory 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.


Office of Criminal Investigations

The
Office of Criminal Investigations The United States Food and Drug Administration The United States The United States of America (USA), commonly known as the United States (U.S. or US), or America, is a country Contiguous United States, primarily located in North Ameri ...
was established in 1991 to investigate criminal cases. To do so, OCI employs approximately 200 Special Agents nationwide who, unlike ORA Investigators, are armed, have badges, and do not focus on technical aspects of the regulated industries. Rather, OCI agents pursue and develop cases when individuals and companies commit criminal actions, such as fraudulent claims or knowingly and willfully shipping known adulterated goods in interstate commerce. In many cases, OCI pursues cases involving violations of
Title 18 of the United States Code Title 18 of the United States Code The Code of Laws of the United States of America (variously abbreviated to Code of Laws of the United States, United States Code, U.S. Code, U.S.C., or USC) is the official compilation and codification C ...
(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 frequently work closely with the
Federal Bureau of Investigation The Federal Bureau of Investigation (FBI) is the domestic intelligence Intelligence has been defined in many ways: the capacity for abstraction Abstraction in its main sense is a conceptual process where general rules and concept Conce ...

Federal Bureau of Investigation
,
Assistant Attorney General Many of the divisions and offices of the United States Department of Justice The United States Department of Justice (DOJ), also known as the Justice Department, is a United States federal executive departments, federal executive department o ...
, and even
Interpol The International Criminal Police Organization (ICPO; french: link=no, Organisation internationale de police criminelle), commonly known as Interpol ( , ), is an international organization An international organization (also known as an ...

Interpol
. OCI receives cases from a variety of sources—including ORA, local agencies, and the FBI, and works with ORA Investigators to help develop the technical and science-based aspects of a case.


Other locations

The FDA has a number of field offices across the United States, in addition to international locations in China, India, Europe, the Middle East, and Latin America.


Scope and funding

The FDA regulates more than US$ 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 these expenditures are for goods imported into the United States; the FDA is responsible for monitoring imports. The FDA's federal budget request for fiscal year (FY) 2012 totaled $4.36 billion, while the proposed 2014 budget is $4.7 billion. About $2 billion of this budget is generated by user fees. Pharmaceutical firms pay the majority of these fees, which are used to expedite drug reviews. 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.


Regulatory programs


Emergency approvals (EUA)

Emergency Use Authorization (EUA) is a mechanism that was created to facilitate the availability and use of medical countermeasures, including vaccines and personal protective equipment, during public health emergencies such as the Zika virus epidemic, the Ebola virus epidemic and the COVID-19 pandemic.


Regulations

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 focuses 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 The U.S. Food and Drug Administration The United States The United States of America (USA), commonly known as the United States (U.S. or US), or America, is a country Contiguous United States, primarily located in North America. It co ...
. In June 2018, the FDA released a statement regarding new guidelines to help food and drug manufacturers "implement protections against potential attacks on the U.S. food supply". One of the new guidelines includes the Intentional Adulteration (IA) rule, which requires strategies and procedures by the food industry to reduce the risk of compromise in facilities and processes that are significantly vulnerable. The FDA also uses tactics of regulatory shaming, mainly through online publication of non-compliance, warning letters, and "shaming lists." Regulation by shaming harnesses firms' sensitivity to reputational damage. For example, in 2018, the agency published an online "black list," in which it named dozens of branded drug companies that are supposedly using unlawful or unethical means to attempt to impede competition from generic drug companies. The FDA frequently works with other federal agencies, including the Department of Agriculture, the
Drug Enforcement Administration The Drug Enforcement Administration (DEA; ) is a Federal law enforcement in the United States, United States federal law enforcement agency under the U.S. Department of Justice tasked with combating drug trafficking and distribution within th ...

Drug Enforcement Administration
, Customs and Border Protection, and the
Consumer Product Safety Commission The United States Consumer Product Safety Commission (USCPSC, CPSC, or commission) is an independent agency of the United States government Independent or Independents may refer to: Arts, entertainment, and media Artist groups * Independents (a ...
. They also often work with local and state government agencies in performing regulatory inspections and enforcement actions.


Food and dietary supplements

The regulation of food and dietary supplements by the Food and Drug Administration is governed by various statutes enacted by the
United States Congress The United States Congress is the legislature of the federal government of the United States. It is Bicameralism, bicameral, comprising a lower body, the United States House of Representatives, House of Representatives, and an upper body, t ...

United States Congress
and interpreted by the FDA. Pursuant to the
Federal Food, Drug, and Cosmetic Act The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by Congress Congresses are formal meetings of the representatives of different countries A country is a distinct terri ...
and accompanying legislation, the FDA has authority to oversee the quality of substances sold as food in the United States, and to monitor claims made in the
labeling Labelling or using a label is describing someone or something in a word or short phrase. For example, describing someone who has broken a law as a criminal. Labeling theory, Labelling theory is a theory in sociology which ascribes labelling of pe ...
of both the composition and the health benefits of foods. The FDA subdivides substances that it regulates as food into various categories—including foods,
food additive Food is any substance consumed to provide nutritional support for an organism In biology, an organism (from Ancient Greek, Greek: ὀργανισμός, ''organismos'') is any individual contiguous system that embodies the Life#Biology ...
s, added substances (man-made substances that are not intentionally introduced into food, but nevertheless end up in it), and
dietary supplements A dietary supplement is a manufactured product intended to supplement one's diet by taking a pill (pharmacy), pill, capsule (pharmacy), capsule, tablet (pharmacy), tablet, powder, or liquid. A supplement can provide nutrients either extra ...
. Dietary supplements or dietary ingredients include vitamins, minerals, herbs, amino acids, and. enzymes. Specific standards the FDA exercises differ from one category to the next. Furthermore, legislation had granted the FDA a variety of means to address violations of standards for a given substance category. Under the
Dietary Supplement Health and Education Act of 1994 The Dietary Supplement Health and Education Act of 1994 ("DSHEA"), is a 1994 statute of United States Federal legislation The Code of Laws of the United States of America (variously abbreviated to Code of Laws of the United States, United States ...
(DSHEA), the FDA is responsible for ensuring that manufacturers and distributors of dietary supplements and dietary ingredients meet the current requirements. These manufacturers and distributors are not allowed to advertise their products in an adulterated way, and they are responsible for evaluating the safety and labeling of their product. The FDA has a “Dietary Supplement Ingredient Advisory List” that includes ingredients that sometimes appear on dietary supplements but need further evaluation further. An ingredient is added to this list when it is excluded from use in a dietary supplement, does not appear to be an approved food additive or recognized as safe, and/or is subjected to the requirement for pre-market notification without having a satisfied requirement.


"FDA-Approved" vs. "FDA-Accepted in Food Processing"

The FDA does not approve applied coatings used in the
food processing industry The food industry is a complex, global network of diverse businesses that supplies most of the food consumed by the World population, world's population. The term food industries covers a series of industrial activities directed at the producti ...
. There is no review process to approve the composition of nonstick coatings; nor does the FDA inspect or test these materials. Through their governing of processes, however, the FDA does have a set of regulations that cover the formulation, manufacturing, and use of nonstick coatings. Hence, materials like
Polytetrafluoroethylene Polytetrafluoroethylene (PTFE) is a synthetic fluoropolymer of tetrafluoroethylene that has numerous applications. The commonly known brand name of PTFE-based compositions is Teflon by Chemours, a corporate spin-off, spin-off from DuPont (1802 ...

Polytetrafluoroethylene
(Teflon) are not, and cannot be, considered as FDA Approved, rather, they are "FDA Compliant" or "FDA Acceptable".


Medical countermeasures (MCMs)

Medical countermeasures (MCMs) are products such as
biologics A biopharmaceutical, also known as a biologic(al) medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, ...

biologics
and
pharmaceutical drug A medication (also called medicament, medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to medical diagnosis, diagnose, cure, therapy, treat, or preventive medicine, prevent disease. Drug therapy (pharmacotherapy) ...
s that can protect from or treat the health effects of a chemical, biological, radiological, or nuclear (CBRN) attack. MCMs can also be used for prevention and diagnosis of symptoms associated with CBRN attacks or threats. The FDA runs a program called the "FDA Medical Countermeasures Initiative" (MCMi), with programs funded by the federal government. It helps support "partner" agencies and organisations prepare for public health emergencies that could require MCMs.


Medications

The
Center for Drug Evaluation and Research The Center for Drug Evaluation and Research (CDER, pronounced "see'-der") is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act. Some biological products are also le ...
uses different requirements for the three main drug product types: new drugs, generic drugs, and over-the-counter drugs. A drug is considered "new" if it is made by a different manufacturer, uses different
excipient An excipient is a substance formulated alongside the active ingredient of a medication, included for the purpose of long-term stabilization, bulking up solid formulations that contain potent active ingredients in small amounts (thus often referred ...
s or inactive ingredients, is used for a different purpose, or undergoes any substantial change. The most rigorous requirements apply to ''new molecular entities'': drugs that are not based on existing medications.


New medications

New drugs receive extensive scrutiny before FDA approval in a process called a new drug application (NDA). Under the Trump administration, the agency has worked to make the drug-approval process go faster. Critics, however, argue that the FDA standards are not sufficiently rigorous, allowing unsafe or ineffective drugs to be approved. 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". Very rare limited exceptions to this multi-step process involving animal testing and controlled clinical trials can be granted out of compassionate use protocols. This was the case during the 2015 Ebola epidemic with the use, by prescription and authorization, of
ZMapp ZMapp is an experimental biopharmaceutical A biopharmaceutical, also known as a biologic(al) medical product, or biologic, is any pharmaceutical drug A medication (also referred to as medicine, pharmaceutical drug, medicinal drug or simply ...
and other experimental treatments, and for new drugs that can be used to treat debilitating and/or very rare conditions for which no existing remedies or drugs are satisfactory, or where there has not been an advance in a long period of time. The studies are progressively longer, gradually adding more individuals as they progress from stage I to stage III, normally over a period of years, and normally involve drug companies, the government and its laboratories, and often medical schools and hospitals and clinics. However, any exceptions to the aforementioned process are subject to strict review and scrutiny and conditions, and are only given if a substantial amount of research and at least some preliminary human testing has shown that they are believed to be somewhat safe and possibly effective. (See FDA Special Protocol Assessment about Phase III trials.)


=Advertising and promotion

= The FDA's Office of Prescription Drug Promotion reviews and regulates prescription drug advertising and promotion through surveillance activities and issuance of enforcement letters to pharmaceutical manufacturers. Advertising and promotion for over-the-counter drugs is regulated by the
Federal Trade Commission The Federal Trade Commission (FTC) is an independent agency of the United States government Independent agencies of the United States federal government The federal government of the United States (U.S. federal government or U.S. gover ...

Federal Trade Commission
. The FDA also empowers third-party enforcer-firms to engage in some regulatory oversight, e.g. the FDA expects pharmaceutical companies to make sure that third-party suppliers and labs abide by the agency's health and safety guidelines. The drug advertising regulation contains two broad requirements: (1) a company may advertise or promote a drug only for the specific indication or medical use for which it was approved by FDA. Also, an advertisement must contain a "fair balance" between the benefits and the risks (side effects) of a drug. The term
off-label Off-label use is the use of pharmaceutical drug A medication (also called medicament, medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to medical diagnosis, diagnose, cure, therapy, treat, or preventive medici ...
refers to drug usage for indications other than those approved by the FDA.


=Post-market safety surveillance

= After NDA approval, the sponsor must then review and report to the FDA every single patient adverse drug experience it learns of. They must report unexpected serious and fatal adverse drug events within 15 days, and other events on a quarterly basis. The FDA also receives directly adverse drug event reports through its
MedWatch MedWatch is the Food and Drug Administration The United States The United States of America (USA), commonly known as the United States (U.S. or US), or America, is a country Contiguous United States, primarily located in North America. ...
program. These reports are called "spontaneous reports" because reporting by consumers and health professionals is voluntary. While this remains the primary tool of post-market safety surveillance, FDA requirements for post-marketing risk management are increasing. As a condition of approval, a sponsor may be required to conduct additional
clinical trials Clinical trials are experiments or observations done in clinical research Clinical research is a branch of healthcare science The following outline is provided as an overview of and topical guide to health sciences: Health sciences &nda ...
, called Phase IV trials. In some cases, the FDA requires risk management plans called
Risk Evaluation and Mitigation StrategiesRisk Evaluation and Mitigation Strategies is a program of the US Food and Drug Administration The United States The United States of America (USA), commonly known as the United States (U.S. or US), or America, is a country Contiguous Un ...
(REMS) for some drugs that require actions to be taken to ensure that the drug is used safely. For example,
thalidomide Thalidomide, sold under the brand names Contergan and Thalomid among others, is a medication used to treat a number of cancers (including multiple myeloma), graft-versus-host disease, and a number of skin conditions including complications of l ...

thalidomide
can cause birth defects, but has uses that outweigh the risks if men and women taking the drugs do not conceive a child; a REMS program for thalidomide mandates an auditable process to ensure that people taking the drug take action to avoid pregnancy; many
opioid Opioids are substances that act on opioid receptors to produce morphine-like effects. Medically they are primarily used for pain relief, including anesthesia. Other medical uses include suppression of diarrhea, replacement therapy for opioid use ...
drugs have REMS programs to avoid addiction and diversion of drugs. The drug
isotretinoin Isotretinoin, also known as 13-''cis''-retinoic acid and sold under the brand name Accutane among others, is a medication primarily used to treat severe acne Acne, also known as acne vulgaris, is a long-term skin condition A skin condi ...

isotretinoin
has a REMS program called iPLEDGE.


Generic drugs

Generic drugs are chemical and therapeutic equivalents of name-brand drugs whose patents have expired. Approved generic drugs should have the same dosage, safety, effectiveness, strength, stability, and quality, as well as route of administration. In general, they are less expensive than their name brand counterparts, are manufactured and marketed by rival companies and, in the 1990s, accounted for about a third of all prescriptions written in the United States. For a pharmaceutical company to gain approval to produce a generic drug, the FDA requires scientific evidence that the generic drug is interchangeable with or therapeutically equivalent to the originally approved drug. This is called an
Abbreviated New Drug Application An Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Generic drugs are ...
(ANDA). As of 2012, 80% of all FDA approved drugs are available in generic form.


=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 during the course of an extensive congressional investigation into the FDA. The oversight subcommittee of the United States House Energy and Commerce Committee resulted from a complaint brought against the FDA by
Mylan Laboratories Inc. Mylan N.V. was a global generic Generic or generics may refer to: In business * Generic term, a common name used for a range or class of similar things not protected by trademark * Generic brand, a brand for a product that does not have an ass ...
of
Pittsburgh Pittsburgh ( ) is a city in the Commonwealth (U.S. state), Commonwealth of Pennsylvania in the United States and the county seat of Allegheny County, Pennsylvania, Allegheny County. A population of 302,971 residents lives within the city limit ...

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 Racketeering is a type of organized crime in which the perpetrators set up a coercion, coercive, fraud, fraudulent, extortionary, or otherwise illegal coordinated Confidence trick , scheme or operation (a racket) to repeatedly or consistently co ...
and in violations of
antitrust law Competition law is a that promotes or seeks to maintain by regulating conduct by companies. Competition law is implemented through public and private enforcement. It is also known as ''anti- law'' in China and Russia. In previous years it has ...
. "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 Endo International plc is an American Irish-domiciled generics and specialty branded pharmaceutical company that generated over 93% of its 2017 sales from the U.S. healthcare system. While Endo's management, operations, and customers are almost e ...
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 The U.S. Securities and Exchange Commission (SEC) is a large independent agency of the United States federal government, created in the aftermath of the Wall Street Crash of 1929 The Wall Street Crash of 1929, also known as the Great Crash ...
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) are drugs like
aspirin Aspirin, also known as acetylsalicylic acid (ASA), is a medication used to reduce pain, fever, or inflammation. Specific inflammatory conditions which aspirin is used to treat include Kawasaki disease, pericarditis, and rheumatic fever. Aspirin ...

aspirin
that do not require a doctor's prescription. The FDA has a list of approximately 800 such 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 A physician (American English American English (AmE, AE, AmEng, USEng, en-US), sometimes called United States English or U.S. English, is the set of variety (linguistics), varieties of the English language native to the United Sta ...

medical practitioner
's supervision like
ibuprofen Ibuprofen is a medication in the nonsteroidal anti-inflammatory drug (NSAID) class that is used for treating pain, fever, and inflammation. This includes dysmenorrhea, painful menstrual periods, migraines, and rheumatoid arthritis. It may also ...

ibuprofen
.


Ebola treatment

In 2014, the FDA added an
Ebola Ebola, also known as Ebola virus disease (EVD) and Ebola hemorrhagic fever (EHF), is a viral hemorrhagic fever Viral hemorrhagic fevers (VHFs) are a diverse group of animal and human illness A disease is a particular abnormal c ...

Ebola
treatment being developed by Canadian pharmaceutical company Tekmira to the Fast Track program, but halted the phase 1 trials in July pending the receipt of more information about how the drug works. This was widely viewed as increasingly important in the face of a major outbreak of the disease in West Africa that began in late March 2014 and ended in June 2016.


Coronavirus (COVID-19) testing

During the
coronavirus pandemic The COVID-19 pandemic, also known as the coronavirus pandemic, is an ongoing global pandemic of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 Severe acute respiratory syndrome coronavi ...
, FDA granted
emergency use authorization#REDIRECT Emergency Use Authorization {{Redirect category shell, {{R from move {{R from other capitalisation {{R unprintworthy ...
for
personal protective equipment Personal protective equipment (PPE) is protective clothing A kanga, worn throughout the African Great Lakes region Clothing (also known as clothes, apparel, and attire) are items worn on the body. Typically, clothing is made of fabr ...
(PPE), in vitro diagnostic equipment,
ventilator A ventilator is a machine that provides mechanical ventilation by moving breathable air into and out of the lungs, to deliver breaths to a patient who is physically unable to breathe, or breathing insufficiently. Ventilators are computer A ...

ventilator
s and other medical devices. On March 18, FDA inspectors postponed most foreign facility inspections and all domestic routine surveillance facility inspections. In contrast, the USDA's
Food Safety and Inspection Service The Food Safety and Inspection Service (FSIS), an agency of the United States Department of Agriculture (USDA), is the public health regulatory agency responsible for ensuring that United States' commercial supply of meat, poultry, and Egg (food ...
(FSIS) continued inspections of meatpacking plants, which resulted in 145 FSIS field employees who tested positive for COVID-19, and three who died.


Vaccines, blood and tissue products, and biotechnology

The
Center for Biologics Evaluation and Research The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the U.S. Food and Drug Administration The United States of America (USA), commonly known as the United States (U.S. or US), or America, is a country pri ...
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 called a
Biologics License Application A biologics license application (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows: The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into interst ...
(BLA), similar to that for drugs. The original authority for government regulation of biological products was established by the 1902
Biologics Control Act The Biologics Control Act of 1902, also known as the Virus-Toxin Law, was the first law that implemented federal regulations of biological products such as vaccine A vaccine is a biological preparation that provides active acquired immunity to ...
, with additional authority established by the 1944
Public Health Service Act The Public Health Service Act is a United States federal law The law of the United States comprises many levels of codified and uncodified forms of law, of which the most important is the nation's Constitution of the United States, Constitution ...
. Along with these Acts, the
Federal Food, Drug, and Cosmetic Act The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by Congress Congresses are formal meetings of the representatives of different countries A country is a distinct terri ...
applies to all biologic products, as well. Originally, the entity responsible for regulation of biological products resided under the
National Institutes of Health The National Institutes of Health (NIH ) is the primary agency of the United States government The federal government of the United States (U.S. federal government or U.S. government) is the national government of the United States ...
; this authority was transferred to the FDA in 1972.


Medical and radiation-emitting devices

The
Center for Devices and Radiological Health The Center for Devices and Radiological Health (CDRH) is the branch of the United States The United States of America (USA), commonly known as the United States (U.S. or US), or America, is a country Contiguous United States, primarily locat ...
(CDRH) is the branch of the FDA responsible for the premarket approval of all
medical device A medical device is any device intended to be used for medical purposes. Significant potential for hazard A hazard is a potential source of harm. Substances, events, or circumstances can constitute hazards when their nature would allow them, e ...
s, 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 A toothbrush is an oral hygiene Oral hygiene is the practice of keeping one's mouth clean and free of disease A disease is a particular abnormal condition that negatively affects the structure A structure is an arrangement and orga ...

toothbrush
to complex devices such as implantable neurostimulators. CDRH also oversees the safety performance of non-medical devices that emit certain types of
electromagnetic radiation In physics Physics is the natural science that studies matter, its Elementary particle, fundamental constituents, its Motion (physics), motion and behavior through Spacetime, space and time, and the related entities of energy and force. ...

electromagnetic radiation
. Examples of CDRH-regulated devices include
cellular phones A mobile phone, cellular phone, cell phone, cellphone, handphone, or hand phone, sometimes shortened to simply mobile, cell or just phone, is a portable telephone A telephone is a telecommunication Telecommunication is the tra ...
, airport baggage screening equipment, ,
microwave oven A microwave oven (commonly referred to as a microwave) is an electric oven upA double oven A ceramic oven An oven is a tool A tool is an object that can extend an individual's ability to modify features of the surrounding environment. ...

microwave oven
s, tanning booths, and . 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.


"FDA-Cleared" vs "FDA-Approved"

Clearance requests are required for medical devices that prove they are "substantially equivalent" to the predicate devices already on the market. Approved requests are for items that are new or substantially different and need to demonstrate "safety and efficacy", for example they may be inspected for safety in case of new toxic hazards. Both aspects need to be proved or provided by the submitter to ensure proper procedures are followed.


Cosmetics

Cosmetics are regulated by the
Center for Food Safety and Applied Nutrition The Center for Food Safety and Applied Nutrition (CFSAN, pronounced sif'-san) is the branch of the United States Food and Drug Administration The United States The United States of America (USA), commonly known as the United States ( ...
, the same branch of the FDA that regulates food. Cosmetic products are not, in general, subject to premarket approval by the FDA unless they make "structure or function claims" that make them into drugs (see Cosmeceutical). However, all color additives must be specifically FDA approved before manufacturers can include them in cosmetic products sold in the U.S. The FDA regulates cosmetics labeling, and cosmetics that have not been safety tested must bear a warning to that effect. According to the industry advocacy group the
American Council on Science and Health The American Council on Science and Health (ACSH) is a pro-industry science advocacy organization founded in 1978 by Elizabeth Whelan. ACSH's publications focus on advocacy related to food, nutrition, health, chemicals, pharmaceuticals, biology ...
, 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 in general does not require pre-market approval or testing. The ACSH says that companies are required to place a warning note on their products if they have not been tested and that experts in cosmetic ingredient reviews also play a role in monitoring safety through influence on the use of ingredients, but also lack legal authority. According to the ACSH, 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 The Center for Veterinary Medicine (CVM) is a branch of the U.S. Food and Drug Administration (FDA) that regulates the manufacture and distribution of food Food is any substance consumed to provide nutritional support for an organism ...
(CVM) is a center of the FDA that regulates food additives and drugs that are given to animals. CVM regulates animal drugs, animal food including pet animal, and animal medical devices. The FDA's requirements to prevent the spread of
bovine spongiform encephalopathy Bovine spongiform encephalopathy (BSE), commonly known as mad cow disease, is a neurodegenerative disease A neurodegenerative disease is caused by the progressive loss of structure or function of neuron A neuron or nerve cell is an membr ...
are also administered by CVM through inspections of feed manufacturers. CVM does not regulate vaccines for animals; these are handled by the
United States Department of Agriculture The United States Department of Agriculture (USDA), also known as the Agriculture Department, is the federal executive department responsible for developing and executing federal laws related to farming, forestry, rural economic development, ...
.


Tobacco products

The FDA regulates
tobacco products The following is an incomplete list of tobacco products. Tobacco village in Xanthi, Greece Tobacco is the common name of several plants in the '' Nicotiana'' genus Genus (plural genera) is a taxonomic rank Taxonomy (general) is th ...
with authority established by the 2009
Family Smoking Prevention and Tobacco Control Act The Family Smoking Prevention and Tobacco Control Act, (, ) is a federal statute in the United States The United States of America (USA), commonly known as the United States (U.S. or US), or America, is a country Contiguous United States, ...
. This Act requires color warnings on cigarette packages and printed advertising, and text warnings from the U.S. Surgeon General. The nine new graphic warning labels were announced by the FDA in June 2011 and were scheduled to be required to appear on packaging by September 2012. The implementation date is uncertain, due to ongoing proceedings in the case of R.J. Reynolds Tobacco Co. v. U.S. Food and Drug Administration.
R.J. Reynolds Richard Joshua "R. J." Reynolds (July 20, 1850 – July 29, 1918) was an American American(s) may refer to: * American, something of, from, or related to the United States of America, commonly known as the United States The United States ...
,
Lorillard Lorillard Tobacco Company was an American tobacco company that marketed cigarettes under the brand names Newport, Maverick, Old Gold (cigarette), Old Gold, Kent (cigarette), Kent, True (cigarette), True, Satin, and Max (cigarette), Max. The comp ...
,
Commonwealth Brands ITG Brands, LLC is the third-largest tobacco manufacturing company in the United States. It is a subsidiary of British Multinational corporation, multinational Imperial Brands. ITG Brands markets and sells multiple cigarette and cigar brands and se ...

Commonwealth Brands
,
Liggett Group Liggett Group ( ), formerly known as Liggett & Myers Tobacco Company, is the fourth largest tobacco company in the United States. Its headquarters are located in Durham, North Carolina, though its manufacturing facility is 30 miles to the west in ...
and Santa Fe Natural Tobacco Company have filed suit in Washington, D.C. federal court claiming that the graphic labels are an
unconstitutional Constitutionality is the condition of acting in accordance with an applicable constitution A constitution is an aggregate of fundamental principles or established precedents that constitute the legal basis of a polity, organisation ...
way of forcing tobacco companies to engage in anti-smoking advocacy on the government's behalf. A
First Amendment First or 1st is the ordinal form of the number one (#1). First or 1st may also refer to: *World record A world record is usually the best global and most important performance that is ever recorded and officially verified in a specific skill, ...
lawyer, Floyd Abrams, is representing the tobacco companies in the case, contending requiring graphic warning labels on a lawful product cannot withstand constitutional scrutiny. The
Association of National Advertisers The Association of National Advertisers (ANA) represents the marketing Marketing refers to activities a company A company, abbreviated as co., is a Legal personality, legal entity representing an association of people, whether Natural pe ...
and the
American Advertising Federation 200px, Logo of the American Advertising Federation until 2021 The American Advertising Federation (AAF), headquartered in Washington, D.C., is the oldest national advertising trade association A trade association, also known as an industry trad ...

American Advertising Federation
have also filed a brief in the suit, arguing that the labels infringe on commercial free speech and could lead to further government intrusion if left unchallenged. In November 2011, Federal judge of the U.S. District Court for the District of Columbia temporarily halted the new labels, likely delaying the requirement that tobacco companies display the labels. The
U.S. Supreme Court The Supreme Court of the United States (SCOTUS) is the highest court in the federal judiciary of the United States of America The United States of America (USA), commonly known as the United States (U.S. or US), or America, is a coun ...

U.S. Supreme Court
ultimately could decide the matter. In July 2017, the FDA announced a plan that would reduce the current levels of nicotine permitted in tobacco cigarettes.


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 device. The FDA also requires milk to be pasteurized to remove bacteria.


International Cooperation

In February 2011,
President President most commonly refers to: *President (corporate title) A president is a leader of an organization, company, community, club, trade union, university or other group. The relationship between a president and a Chief Executive Officer, chi ...

President
Barack Obama and Prime Minister of Canada, Canadian Prime Minister Stephen Harper issued a "Declaration on a Shared Vision for Perimeter Security and Economic Competitiveness" and announced the creation of the Canada-United States Regulatory Cooperation Council (RCC) "to increase regulatory transparency and coordination between the two countries.” Under the RCC mandate, the FDA and Health Canada undertook a "first of its kind" initiative by selecting "as its first area of alignment common cold indications for certain over-the-counter antihistamine ingredients (GC 2013-01-10)." A more recent example of the FDA's international work is their 2018 cooperation with regulatory and law-enforcement agencies worldwide through
Interpol The International Criminal Police Organization (ICPO; french: link=no, Organisation internationale de police criminelle), commonly known as Interpol ( , ), is an international organization An international organization (also known as an ...

Interpol
as part of Operation Pangea XI. The FDA targeted 465 websites that illegally sold potentially dangerous, unapproved versions of
opioid Opioids are substances that act on opioid receptors to produce morphine-like effects. Medically they are primarily used for pain relief, including anesthesia. Other medical uses include suppression of diarrhea, replacement therapy for opioid use ...
, Chemotherapy, oncology, and Antiviral drug, antiviral prescription drugs to U.S. consumers. The agency focused on money laundering, transaction laundering schemes in order to uncover the complex online drug network.


Science and research programs

The FDA Science policy of the United States, carries out research and development activities to develop technology and standards that support its regulatory role, with the objective of resolving scientific and technical challenges before they become impediments. The FDA's research efforts include the areas of biologics, medical devices, drugs, women's health, toxicology, food safety and applied nutrition, and veterinary medicine.


Data management

The FDA has collected a large amount of data through the decades. The OpenFDA project was created to enable easy access of the data for the public and was officially launched in June 2014.


History

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. The history of the FDA can be traced to the latter part of the 19th century and the Division of Chemistry of the U.S. Department of Agriculture, which United_States_Department_of_Agriculture#Origins_in_the_Patent_Office, was itself derived from the Copyright and Patent Clause. 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. Wiley's advocacy came at a time when the public had become aroused to hazards in the marketplace by muckraker, 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 Biologics Control Act, Biologics Control Act of 1902 was put in place after a diphtheria antitoxin—derived from tetanus-contaminated serum—was used to produce a vaccine that caused the deaths of thirteen children in St. Louis, Missouri. The serum was originally collected from a horse named Jim (horse), Jim who had contracted tetanus. In June 1906, President Theodore Roosevelt signed into law the Pure Food and Drug Act, Pure Food and Drug Act of 1906, also known as the "Wiley Act" after its chief advocate. The Act prohibited, under penalty of seizure of goods, the interstate transport of food that had been "adulterated". 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 Pharmacopeia'' or the ''National Formulary''. 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, which narrowly defined the bureau's powers and 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 Administration. This name was shortened to the Food and Drug Administration (FDA) three years later. By the 1930s, Muckraker, muckraking journalists, consumer protection organizations, and federal regulators began mounting a campaign for stronger regulatory authority by publicizing a list of injurious products that had been ruled permissible under the 1906 law, including radioactive beverages, the mascara Lash lure 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, Elixir Sulfanilamide tragedy, in which over 100 people died after using a drug formulated with a toxic, untested solvent. President Franklin Delano Roosevelt signed the
Federal Food, Drug, and Cosmetic Act The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by Congress Congresses are formal meetings of the representatives of different countries A country is a distinct terri ...
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. 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 drug, prescription-only" drugs was securely codified into law by the Durham-Humphrey Amendment in 1951. These developments confirmed extensive powers for the FDA to enforce post-marketing recalls of ineffective drugs. Outside of the US, the drug
thalidomide Thalidomide, sold under the brand names Contergan and Thalomid among others, is a medication used to treat a number of cancers (including multiple myeloma), graft-versus-host disease, and a number of skin conditions including complications of l ...

thalidomide
was marketed for the relief of general nausea and morning sickness, but caused birth defects and even the death of thousands of babies when taken during pregnancy. American mothers were largely unaffected as Dr. Frances Oldham Kelsey of the FDA refused to authorize the medication for market. In 1962, the Kefauver-Harris Amendment to the FD&C Act was passed, which 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. These reforms had the effect of increasing the time, and the difficulty, required to bring a drug to market. One of the most important statutes in establishing the modern American pharmaceutical market was the 1984 Drug Price Competition and Patent Term Restoration Act, more commonly known as the "Hatch-Waxman Act" after its chief sponsors. The act extended the patent exclusivity terms of new drugs, and tied those extensions, in part, to the length of the FDA approval process for each individual drug. For generic manufacturers, the Act created a new approval mechanism, the
Abbreviated New Drug Application An Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Generic drugs are ...
(ANDA), in which the generic drug manufacturer need only demonstrate that their generic formulation has the same active ingredient, route of administration, dosage form, strength, and pharmacokinetics, pharmacokinetic properties ("bioequivalence") as the corresponding brand-name drug. This Act has been credited with, in essence, creating the modern generic drug industry. 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. 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. All of the initial drugs approved for the treatment of HIV/AIDS were approved through these accelerated approval mechanisms. Frank Young, then commissioner of the FDA, was behind the Action Plan Phase II, established in August 1987 for quicker approval of AIDS medication. In two instances, state governments have sought to legalize drugs that the FDA has not approved. Under the theory that 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. The second wave concerned medical marijuana in the 1990s and 2000s. Though Cannabis in Virginia, Virginia passed legislation allowing doctors to recommend cannabis for glaucoma or the side effects of chemotherapy, a more widespread trend began in California with the 1996 California Proposition 215, Compassionate Use Act of 1996. When the FDA requested Endo Pharmaceuticals on June 8, 2017, to remove ''oxymorphone hydrochloride'' from the market, it was the first such request in FDA history.


21st century reforms


Critical Path Initiative

The Critical Path Initiative is the 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

The Compassionate Investigational New Drug program was created after ''Randall v. U.S.'' ruled in favor of Robert C. Randall in 1978, creating a program for medical marijuana. 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. Criticism of the Food and Drug Administration, 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 (NSAID) now estimated to have contributed to fatal myocardial infarction, 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  Retrieved August 30, 2012. for reforms in the FDA's procedures for pre- and post-market drug safety regulation. In 2006, a United States congressional committee, Congressional 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 medicine medical research, economics, biostatistics, law, public policy, public health, and the allied health professions, as well as current and former executives from the drug company, 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 were incorporated into drafts of the PDUFA IV amendment, which was signed into law as the Food and Drug Administration Amendments Act of 2007. As of 2011, Risk Minimization Action Plans (RiskMAPS) have been created to ensure risks of a drug never outweigh the benefits of that drug within the post-marketing period. This program requires that manufacturers design and implement periodic assessments of their programs' effectiveness. The Risk Minimization Action Plans are set in place depending on the overall level of risk a prescription drug is likely to pose to the public.


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. Children react differently to the drugs because of many reasons, including size, weight, etc. There were several reasons that few 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 that 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 Food and Drug Administration Modernization Act, Food and Drug Administration Modernization Act of 1997 to pass incentives that gave pharmaceutical manufacturers a six-month patent term extension on new drugs submitted with pediatric trial data. The Best Pharmaceuticals for Children Act, Best Pharmaceuticals for Children Act of 2007 reauthorized these provisions and allowed the FDA to request National Institutes of Health, NIH-sponsored testing for pediatric drug testing, although these requests are subject to NIH funding constraints. 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.


Priority review voucher (PRV)

The priority review voucher is a provision of the Food and Drug Administration Amendments Act of 2007, which awards a transferable "priority review voucher" to any company that obtains approval for a treatment for a neglected tropical diseases. The system was first proposed by Duke University faculty David Ridley, Henry Grabowski, and Jeffrey Moe in their 2006 ''Health Affairs'' paper: "Developing Drugs for Developing Countries". President Obama signed into law the Food and Drug Administration Safety and Innovation Act, Food and Drug Administration Safety and Innovation Act of 2012 which extended the authorization until 2017.


Rules for generic biologics

Since the 1990s, many successful new drugs for the treatment of cancer, autoimmunity, autoimmune diseases, and other conditions have been protein-based biologic medical product, biotechnology drugs, regulated by the
Center for Biologics Evaluation and Research The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the U.S. Food and Drug Administration The United States of America (USA), commonly known as the United States (U.S. or US), or America, is a country pri ...
. 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 Imiglucerase, 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 Drug Price Competition and Patent Term Restoration Act, Hatch-Waxman Act did not include biologics in the
Abbreviated New Drug Application An Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Generic drugs are ...
(ANDA) process. This precluded 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.


Mobile medical applications

In 2013, a guidance was issued to regulate mobile medical apps, mobile medical applications and protect users from their unintended use. This guidance distinguishes the apps subjected to regulation based on the marketing claims of the apps. Incorporation of the guidelines during the development phase of these apps has been proposed for expedited market entry and clearance.


Criticisms

The FDA 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 $1.8million 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 regulations, regulatory powers, funding, and independence of the FDA.Webcitation.org
/ref> 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 Libertarianism, libertarian Mercatus Center, 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 their 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, in particular 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), 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.


See also

* Adverse reaction * Adverse event * Adverse drug reaction * Biosecurity * Biosecurity in the United States * Drug Efficacy Study Implementation * Food and Drug Administration Modernization Act of 1997 * FDA Food Safety Modernization Act, FDA Food Safety Modernization Act of 2011 * FDA Fast Track Development Program (for drugs) * Food and Drug Administration Amendments Act of 2007 (e.g. drugs) * Food and Drug Administration Safety and Innovation Act, Food and Drug Administration Safety and Innovation Act of 2012 (GAIN/QIDP etc.) * Inverse benefit law * Investigational Device Exemption (for use in clinical trials) * Kefauver Harris Amendment 1962 – required "proof-of-efficacy" for drugs International: * Food Administration * International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) * Australia: Therapeutic Goods Administration * Brazil: National Health Surveillance Agency * Canada: Marketed Health Products Directorate * Canada: Health Canada * Denmark: Danish Medicines Agency * European Union: European Medicines Agency * Germany: Federal Institute for Drugs and Medical Devices * India: Food Safety and Standards Authority of India * India: Central Drugs Standard Control Organization * Japan: Ministry of Health, Labour and Welfare (MHLW) * Japan: Pharmaceuticals and Medical Devices Agency * Mexico: Federal Commission for the Protection against Sanitary Risk *Philippines: Food and Drug Administration (Philippines), Food and Drug Administration (FDA) * Singapore: Health Sciences Authority * United Kingdom: Medicines and Healthcare products Regulatory Agency * United States: Food and Drug Administration


Notes


References


Further reading

* Givel, Michael (December 2005). "Philip Morris' FDA Gambit: Good for Public Health?" ''Journal of Public Health Policy'' (26): pp. 450–468 * * Hilts, Philip J. (2003). ''Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation.'' New York: Alfred E. Knopf. * Kevin Fain, Matthew Daubresse, G. Caleb Alexander (2013). "The Food and Drug Administration Amendments Act and Postmarketing Commitments." "JAMA" 310(2): 202–204 . * Madden, Bartley (2010) ''Free To Choose Medicine: How Faster Access to New Drugs Would Save Countless Lives and End Needless Suffering'' Chicago: The Heartland Institute. * Moore, Thomas J. (1998). ''Prescription for Disaster: The Hidden Dangers in Your Medicine Cabinet.'' New York: Simon & Schuster. * Obenchain, Janel, and Arlene Spark. Food Policy: Looking Forward from the Past. CRC Press, 2015.


External links

*
Food and Drug Administration
in the Federal Register
FDA Organizational Hierarchy Chart
in PDF format
Strategic Plan
*
Online books by United States Food and Drug Administration
at Online Books Page, The Online Books Page {{DEFAULTSORT:Food And Drug Administration (United States) Food and Drug Administration, 1906 establishments in the United States American medical research Government agencies established in 1906 Regulators of biotechnology products