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Thursday, July 9, 2020

Coalition government

From Wikipedia, the free encyclopedia
 
A coalition government is a form of government in which political parties cooperate, reducing the dominance of any one party within that "coalition". The usual reason for this arrangement is that no party on its own can achieve a majority in the election. A coalition government might also be created in a time of national difficulty or crisis (for example, during wartime or economic crisis) to give a government the high degree of perceived political legitimacy or collective identity, it can also play a role in diminishing internal political strife. In such times, parties have formed all-party coalitions (national unity governments, grand coalitions). If a coalition collapses, a confidence vote is held or a motion of no confidence is taken.

Practice

When a general election does not produce a clear majority for a single party, parties either form coalition cabinets, supported by a parliamentary majority, or minority cabinets which may consist of one or more parties. Cabinets based on a group of parties that command a majority in parliament tend to be more stable and long-lived than minority cabinets. While the former are prone to internal struggles, they have less reason to fear votes of no confidence. Majority governments based on a single party are typically even more stable, as long as their majority can be maintained.

Distribution

Countries which often operate with coalition cabinets include: the Nordic countries, the Benelux countries, Australia, Austria, Cyprus, France, Germany, Greece, India, Indonesia, Ireland, Israel, Italy, Japan, Kenya, Kosovo, Lithuania, Latvia, Lebanon, Nepal, New Zealand, Pakistan, Thailand, Trinidad and Tobago, Turkey and Ukraine. Switzerland has been ruled by a coalition of the four strongest parties in parliament from 1959 to 2008, called the "Magic Formula". Between 2010 and 2015, the United Kingdom also operated a formal coalition between the Conservative and the Liberal Democrat parties, but this was unusual: the UK usually has a single-party majority government.

Coalitions composed of few parties

United Kingdom

In the United Kingdom, coalition governments (sometimes known as "national governments") usually have only been formed at times of national crisis. The most prominent was the National Government of 1931 to 1940. There were multi-party coalitions during both world wars. Apart from this, when no party has had a majority, minority governments normally have been formed with one or more opposition parties agreeing to vote in favour of the legislation which governments need to function: for instance the Labour government of James Callaghan formed a pact with the Liberals from March 1977 until July 1978, after a series of by-election defeats had eroded Labour's majority of three seats which had been gained at the October 1974 election. However, in the run-up to the 1997 general election, Labour opposition leader Tony Blair was in talks with Liberal Democrat leader Paddy Ashdown about forming a coalition government if Labour failed to win a majority at the election; but there proved to be no need for a coalition as Labour won the election by a landslide. The 2010 general election resulted in a hung parliament (Britain's first for 36 years), and the Conservatives, led by David Cameron, which had won the largest number of seats, formed a coalition with the Liberal Democrats in order to gain a parliamentary majority, ending 13 years of Labour government. This was the first time that the Conservatives and Lib Dems had made a power-sharing deal at Westminster. It was also the first full coalition in Britain since 1945, having been formed 70 years virtually to the day after the establishment of Winston Churchill's wartime coalition, Labour and the Liberal Democrats have entered into a coalition twice in the Scottish Parliament, as well as twice in the Welsh Assembly.

Germany

In Germany, for instance, coalition government is the norm, as it is rare for either the Christian Democratic Union of Germany together with their partners the Christian Social Union in Bavaria (CDU/CSU), or the Social Democratic Party of Germany (SPD), to win an unqualified majority in a national election. Thus, at the federal level, governments are formed with at least two parties. For example, Helmut Kohl's CDU governed for years in coalition with the Free Democratic Party (FDP); from 1998 to 2005 Gerhard Schröder's SPD was in power with the Greens; and from 2009 Angela Merkel, CDU/CSU was in power with the FDP.

"Grand coalitions" of the two large parties also occur, but these are relatively rare, as large parties usually prefer to associate with small ones. However, if none of the larger parties can receive enough votes to form their preferred coalition, a grand coalition might be their only choice for forming a government. This was the situation in Germany in 2005 when Angela Merkel became Chancellor: in early elections, the CDU/CSU did not garner enough votes to form a majority coalition with the FDP; similarly the SPD and Greens did not have enough votes to continue with their formerly ruling coalition. A grand coalition government was subsequently forged between the CDU/CSU and the SPD. Partnerships like these typically involve carefully structured cabinets. The CDU/CSU ended up holding the Chancellery while the SPD took the majority of cabinet posts. Parties frequently make statements ahead of elections which coalitions they categorically reject, similar to election promises or shadow cabinets in other countries.

In Germany, coalitions rarely consist of more than two parties (CDU and CSU, two allies which always form a single caucus, are in this regard considered a single party). However, in the 2010s coalitions on the state level increasingly included three different parties, often FDP, Greens and one of the major parties or "red red green" coalitions of SPD, Linkspartei and Greens. By 2016, the Greens have joined governments on the state level in eleven coalitions in seven various constellations.

Examples of coalitions

Armenia

Armenia became an independent state in 1991, following the collapse of the Soviet Union. Since then, many political parties were formed in it, who mainly work with each other to form coalition governments. Currently the country is governed by the My Step Alliance coalition after successfully gaining a majority in the National Assembly of Armenia following the 2018 Armenian parliamentary election.

Australia

In federal Australian politics, the conservative Liberal, National, Country Liberal and Liberal National parties are united in a coalition, known simply as the Coalition. The Coalition has become so stable, at least at the federal level, that in practice the lower house of Parliament has become a two-party house, with the Coalition and the Labor Party being the major parties. This coalition is also found in the states of New South Wales and Victoria. In South Australia and Western Australia the Liberal and National parties compete separately, while in the Northern Territory and Queensland the two parties have merged, forming the Country Liberal Party, in 1978, and the Liberal National Party, in 2008, respectively. 

The other federal coalition has been:

Belgium

In Belgium, where there are separate Dutch-speaking and French-speaking parties for each political grouping, coalition cabinets of up to six parties are common.

Canada

In Canada, the Great Coalition was formed in 1864 by the Clear Grits, Parti bleu, and Liberal-Conservative Party. During the First World War, Prime Minister Robert Borden attempted to form a coalition with the opposition Liberals to broaden support for controversial conscription legislation. The Liberal Party refused the offer but some of their members did cross the floor and join the government. Although sometimes referred to as a coalition government, according to the definition above, it was not. It was disbanded after the end of the war.

As a result of the 1919 Ontario election, the United Farmers of Ontario and the Labour Party, together with three independent MLAs, formed a coalition that governed Ontario until 1923.

In British Columbia, the governing Liberals formed a coalition with the opposition Conservatives in order to prevent the surging, left-wing Cooperative Commonwealth Federation from taking power in the 1941 British Columbia general election. Liberal premier Duff Pattullo refused to form a coalition with the third-place Conservatives, so his party removed him. The Liberal–Conservative coalition introduced a winner-take-all preferential voting system (the "Alternative Vote") in the hopes that their supporters would rank the other party as their second preference; however, this strategy did not take CCF second preferences into account. In the 1952 British Columbia general election, to the surprise of many, the right-wing populist BC Social Credit Party won a minority. They were able to win a majority in the subsequent election as Liberal and Conservative supporters shifted their anti-CCF vote to Social Credit.

Manitoba has had more formal coalition governments than any other province. Following gains by the United Farmer's/Progressive movement elsewhere in the country, the United Farmers of Manitoba unexpectedly won the 1921 election. Like their counterparts in Ontario, they had not expected to win and did not have a leader. They asked John Bracken, a professor in animal husbandry, to become leader and premier. Bracken changed the party's name to the Progressive Party of Manitoba. During the Great Depression, Bracken survived at a time when other premiers were being defeated by forming a coalition government with the Manitoba Liberals (eventually, the two parties would merge into the Liberal-Progressive Party of Manitoba, and decades later, the party would change its name to the Manitoba Liberal Party). In 1940, Bracken formed a wartime coalition government with almost every party in the Manitoba Legislature (the Conservatives, CCF, and Social Credit; however, the CCF broke with the coalition after a few years over policy differences). The only party not included was the small, communist Labor-Progressive Party, which had a handful of seats.

In Saskatchewan, NDP premier Roy Romanow formed a formal coalition with the Saskatchewan Liberals in 1999 after being reduced to a minority. After two years, the newly elected Liberal leader David Karwacki ordered the coalition be disbanded, the Liberal caucus disagreed with him and left the Liberals to run as New Democrats in the upcoming election. The Saskatchewan NDP was re-elected with a majority under its new leader Lorne Calvert, while the Saskatchewan Liberals lost their remaining seats and have not been competitive in the province since. 

According to historian Christopher Moore, coalition governments in Canada became much less possible in 1919, when the leaders of parties were no longer chosen by elected MPs but instead began to be chosen by party members. Such a manner of leadership election had never been tried in any parliamentary system before. According to Moore, as long as that kind of leadership selection process remains in place and concentrates power in the hands of the leader, as opposed to backbenchers, then coalition governments will be very difficult to form. Moore shows that the diffusion of power within a party tends to also lead to a diffusion of power in the parliament in which that party operates, thereby making coalitions more likely.

During the 2008–09 Canadian parliamentary dispute, two of Canada's opposition parties signed an agreement to form what would become the country's second coalition government since Confederation if the minority Conservative government was defeated on a vote of non-confidence, unseating Stephen Harper as Prime Minister. The agreement outlined a formal coalition consisting of two opposition parties, the Liberal Party and the New Democratic Party. The Bloc Québécois agreed to support the proposed coalition on confidence matters for 18 months. In the end, parliament was prorogued by the Governor General, and the coalition dispersed before parliament was reconvened.

Denmark

From the creation of the Folketing in 1849 through the introduction of proportional representation in 1918, there were only single-party governments in Denmark. Thorvald Stauning formed his second government and Denmark's first coalition government in 1929. With the exception of a string of one-party governments during the 1970s, the norm since 1929 has been coalition governments. Every government from 1982 until the 2015 elections were coalitions. The most recent coalition was Løkke's third government, which was replaced by the one-party Frederiksen government in 2019.

When the Social Democrats under Stauning won 46% of the votes in the 1935 election, this was the closest any party has gotten to winning an outright majority in parliament. One party has thus never held a majority alone, and even one-party governments since 1918 have needed the support of at least one other party to govern. For example, the current government consists only of the Social Democrats, but also relies on the support of the Social Liberal Party, the Socialist People's Party, and the Red–Green Alliance.

Finland

In Finland, no party has had an absolute majority in the parliament since independence, and multi-party coalitions have been the norm. Finland experienced its most stable government (Lipponen I and II) since independence with a five-party governing coalition, a so-called "rainbow government". The Lipponen cabinets set the stability record and were unusual in the respect that both the centre-left (SDP) and radical left-wing (Left Alliance) parties sat in the government with the major centre-right party (National Coalition). The Katainen cabinet was also a rainbow coalition of a total of five parties.

India

Since India's Independence on 15 August 1947, Indian National Congress, the major political party instrumental in Indian independence movement, ruled the nation. The first Prime Minister Jawaharlal Nehru, second PM Lal Bahadur Shastri and the third PM Indira Gandhi, all were from the Congress party. However, Raj Narain, who had unsuccessfully contested election against Indira from the constituency of Rae Bareilly in 1971, lodged a case, alleging electoral malpractices. In June 1975, Indira was found guilty and barred by High Court from holding public office for six years. In response, an ungracious Emergency was declared under the pretext of national security. The next election's result was that India's first-ever coalition government was formed at the national level under the Prime Ministership of Morarji Desai, which was also the first non-Congress national government, which existed from 24 March 1977 to 15 July 1979, headed by the Janata Party, an amalgam of political parties opposed to Emergency imposed between 1975 and 1977. As the popularity of Janata Party dwindled, Morarji Desai had to resign and Charan Singh, a rival of Desai became the fifth PM. However, due to lack of support, this coalition government did not complete its five-year term.

Congress returned to the power in 1980 under Indira Gandhi, and later under Rajiv Gandhi as the 6th PM. However, the next general election of 1989 once again brought a coalition government under National Front, which lasted until 1991, with two Prime Ministers, the second one being supported by Congress. The 1991 election resulted in a Congress led stable minority government for five years. The next 11th parliament produced three Prime Ministers in two years and forced the country back to the polls in 1998. The first successful coalition government in India which completed the whole 5-year term was the Bharatiya Janata Party (BJP) led National Democratic Alliance with Atal Bihari Vajpayee as PM from 1999 to 2004. Then another coalition, Congress led United Progressive Alliance, consisting of 13 separate parties ruled India for two terms from 2004 to 2014 with Manmohan Singh as PM. However, in the 16th general election in May 2014, BJP secured majority on its own (first party to do so since 1984 election) and National Democratic Alliance came into power, with Narendra Modi as Prime Minister. In 2019, Narendra Modi got re-elected as Prime Minister for the second time as National Democratic Alliance again secured majority in the 17th general election.

Indonesia

As a result of the toppling of Suharto, political freedom is significantly increased. Compared to only three parties allowed to exist in the New Order era, a total of 48 political parties participated in the 1999 election, a total of 24 parties in the 2004 election, 38 parties in the 2009 election, and 15 parties in the 2014 election. There are no majority winner of those elections and coalition governments are inevitable. The current government is a coalition of seven parties led by the PDIP and Golkar.

Ireland

In Ireland, coalition governments are common; not since 1977 has a single party formed a majority government. Coalition governments to date have been led by either Fianna Fáil or Fine Gael. They have been joined in government by one or more smaller parties or independent members of parliament (TDs).

Ireland's first coalition government was formed after the 1948 general election, with five parties and independents represented at cabinet. Before 1989, Fianna Fáil had opposed participation in coalition governments, preferring single-party minority government instead. It formed a coalition government with the Progressive Democrats in that year.

The Labour Party has been in government on eight occasions. On all but one of those occasions, it was as a junior coalition party to Fine Gael. The exception was a government with Fianna Fáil from 1993 to 1994. The Government of the 31st Dáil (2011–16), though a traditional Fine Gael–Labour coalition, was a grand coalition of the two largest parties, as Fianna Fáil had fallen to third place in the Dáil.

The current government is minority Fine Gael government with Independents at cabinet, supported by a confidence and supply arrangement with Fianna Fáil.

Israel

A similar situation exists in Israel, which typically has at least 10 parties holding representation in the Knesset. The only faction to ever gain the majority of Knesset seats was Alignment, an alliance of the Labor Party and Mapam that held an absolute majority for a brief period from 1968 to 1969. Historically, control of the Israeli government has alternated between periods of rule by the right-wing Likud in coalition with several right-wing and religious parties and periods of rule by the center-left Labor in coalition with several left-wing parties. Ariel Sharon's formation of the centrist Kadima party in 2006 drew support from former Labor and Likud members, and Kadima ruled in coalition with several other parties.

Israel also formed a national unity government from 1984–1988. The premiership and foreign ministry portfolio were held by the head of each party for two years, and they switched roles in 1986.

Japan

Post-World War II Japan has historically been dominated by the Liberal Democratic Party, but there was a brief coalition government formed after the 1993 election following LDP's first loss of its overall House of Representatives majority since 1955, winning only 223 out of 511 seats. The LDP government was replaced by an eight-party coalition government, which consisted of all of the previous opposition parties excluding the Japanese Communist Party, who together controlled 243 seats. Every Japanese government since then has been a coalition government in one way or another.

New Zealand

MMP was introduced in New Zealand in the 1996 election. In order to get into power, parties need to get a total of 50% of the 121 seats in parliament – 61. Since no parties have ever gotten a full majority, they must form coalitions with other parties. For example, during the 2017 general election, Labour got 46 seats and New Zealand First got nine. The two formed a Coalition Government with confidence and supply from the Green Party which got eight seats.

Spain

Since 2015, there are many more coalition governments than previously in municipalities, autonomous regions and, since 2020 (coming from the November 2019 Spanish general election), in the Spanish Government. There are two ways of conforming them: all of them based on a program and its institutional architecture, one consists on distributing the different areas of government between the parties conforming the coalition and the other one is, like in the Valencian Community, where the ministries are structured with members of all the political parties being represented, so that conflicts that may occur are regarding competences and not fights between parties.

Coalition governments in Spain had already existed during the 2nd Republic, and have been common in some specific Autonomous Communities since the 80's. Nonetheless, the prevalence of two big parties overall has been eroded and the need for coalitions appears to be the new normal since around 2015.

Uruguay

Since the 1989 election, there have been 4 coalition governments, all including at least both the conservative National Party and the liberal Colorado Party. The first one was after the election of the blanco Luis Alberto Lacalle and lasted until 1992 due to policy disagreements, the longest lasting coalition was the Colorado-led coalition under the second government of Julio María Sanguinetti, in which the national leader Alberto Volonté was frequently described as a "Prime Minister", the next coalition (under president Jorge Batlle) was also Colorado-led, but it lasted only until after the 2002 Uruguay banking crisis, when the blancos abandoned the government. After the 2019 Uruguayan general election, the blanco Luis Lacalle Pou formed the coalición multicolor, composed of his own National Party, the liberal Colorado Party, the right wing populist Open Cabildo and the center left Independent Party.

Criticism

Advocates of proportional representation suggest that a coalition government leads to more consensus-based politics, as a government comprising differing parties (often based on different ideologies) need to compromise about governmental policy. Another stated advantage is that a coalition government better reflects the popular opinion of the electorate within a country.

Those who disapprove of coalition governments believe that such governments have a tendency to be fractious and prone to disharmony, as their component parties hold differing beliefs and thus may not always agree on policy. Sometimes the results of an election mean that the coalitions which are mathematically most probable are ideologically infeasible, for example in Flanders or Northern Ireland. A second difficulty might be the ability of minor parties to play "kingmaker" and, particularly in close elections, gain far more power in exchange for their support than the size of their vote would otherwise justify.

Coalition governments have also been criticized for sustaining a consensus on issues when disagreement and the consequent discussion would be more fruitful. To forge a consensus, the leaders of ruling coalition parties can agree to silence their disagreements on an issue to unify the coalition against the opposition. The coalition partners, if they control the parliamentary majority, can collude to make the parliamentary discussion on the issue irrelevant by consistently disregarding the arguments of the opposition and voting against the opposition's proposals — even if there is disagreement within the ruling parties about the issue.

Powerful parties can also act in an oligocratic way to form an alliance to stifle the growth of emerging parties. Of course, such an event is rare in coalition governments when compared to two-party systems, which typically exist because of stifling of the growth of emerging parties, often through discriminatory nomination rules regulations and plurality voting systems, and so on.

A single, more powerful party can shape the policies of the coalition disproportionately. Smaller or less powerful parties can be intimidated to not openly disagree. In order to maintain the coalition, they would have to vote against their own party's platform in the parliament. If they do not, the party has to leave the government and loses executive power. However, this is contradicted by the "kingmaker" factor mentioned above.

Biosecurity in the United States

From Wikipedia, the free encyclopedia
 
Biosecurity in the United States is governed by the Bureau of Western Hemisphere Affairs, which is part of the US Department of State. It obtains guidance and advice on specific matters relating to biosecurity from various other government agencies.

Biosecurity is set of measures aimed at preventing the introduction and/or spread of harmful organisms, in order to minimise the risk of transmission of infectious diseases to people, animals and plants caused by viruses, bacteria or other microorganisms. As well as protecting the agricultural economy and other industries of countries, it protects human health against biorisks caused by natural occurrences, accident, or deliberate acts of bioterrorism. The term also extends to dealing with epidemic and pandemic diseases, with the World Health Organisation (WHO) playing an important role in the management of the latter. WHO has described biosecurity as a strategic and integrated approach to analysing and managing relevant risks to human, animal and plant life and health and associated risks for the environment.

Biosecurity protocols are also used in laboratories and research facilities to prevent dangerous biological materials from falling into the hands of malevolent parties, particularly where dual-use research is being undertaken, for both peaceful and military applications.

Terminology

The term "biosecurity" has multiple meanings and is defined differently according to various disciplines. The term was first used by the agricultural and environmental communities. Starting from the late 1990s in response to the threat of biological terrorism, biosecurity encompasses the prevention of the theft of biological materials from research laboratories. These preventative measures are a combination of systems and practices put into its place at bioscience laboratories to prevent the use of dangerous pathogens and toxins for malicious use, as well as by customs agents and agricultural and natural resource managers to prevent the spread of these biological agents.

WHO has described biosecurity as a strategic and integrated approach to analysing and managing relevant risks to human, animal and plant life and health and associated risks for the environment.

The term has in the past been used purely to describe preventive and quarantine measures put in place to minimise the risk of invasive pests or diseases arriving at a specific location that could damage crops and livestock as well as the wider environment. However, the term has evolved to encompass much more. It includes managing biological threats to people, industries or environment. These may be from foreign or endemic organisms, but they can also extend to pandemic diseases and the threat of bioterrorism.

US definitions

In 2001, the US National Association of State Departments of Agriculture (NASDA) defined biosecurity as "the sum of risk management practices in defense against biological threats", and its main goal as "protect[ing] against the risk posed by disease and organisms".

The USDA Animal and Plant Health Inspection Service (APHIS) defines biosecurity as "everything that’s done to keep diseases and the pathogens that carry them – viruses, bacteria, funguses, parasites and other microorganisms – away from birds, property, and people".

The National Academy of Sciences defines biosecurity as "security against the inadvertent, inappropriate, or intentional malicious or malevolent use of potentially dangerous biological agents or biotechnology, including the development, production, stockpiling, or use of biological weapons as well as outbreaks of newly emergent and epidemic disease". It is thus one aspect of health security.

Governance and legislation

In the US, biosecurity is governed by the Bureau of Western Hemisphere Affairs, which is within the Department of State. The Bureau promotes global health security as part of its role in the biodefense network, "because infectious disease threats, whether naturally occurring, deliberate, or accidental, have the potential to spread globally and affect American people and interests". The Department of State works with other US government agencies such as the Department of Defense, Department of Health and Human Services (HHS), Centers for Disease Control (CDC), and National Institutes of Health (NIH), and also international organizations like the Pan American Health Organization and partner countries in order to protect US citizens.

The National Science Advisory Board for Biosecurity is a panel of experts that reports to the Secretary of the United States Department of Health and Human Services. It is tasked with recommending policies on such questions as how to prevent published research in biotechnology from aiding terrorism, without slowing scientific progress. It provides "advice, guidance, and leadership regarding biosecurity oversight of dual-use research to all Federal departments and agencies with an interest in life sciences research".

The Federal Select Agent Program (FSAP) regulates the use of biological select agents and toxins that could pose a severe threat directly to human, animal or plant health, or to animal or plant products that may be consumed. FSAP is jointly managed by the Division of Select Agents and Toxins (DSAT) at the CDC, which is part of the HHS, and the Agriculture Select Agent Services (AgSAS) at APHIS, which is part of the US Department of Agriculture (USDA). DSAT is concerned with human health, while AgSAS is concerned with animals and plants.

Securing our Agriculture and Food Act 2017

A bipartisan bill described as an "agro-terrorism bill" was signed by the President and passed in both houses 2017, the result of concerns raised after the 2015 outbreak of avian influenza that had a devastating effect on poultry in Iowa. The response to that emergency had revealed cracks in the federal government’s ability to react quickly to this type of large-scale animal disease outbreak, and raised concerns about the nation's ability to respond to agro-terrorism. The new legislation, called Securing our Agriculture and Food Act (H.R. 1238), amended the Homeland Security Act of 2002 and requires the Secretary of Homeland Security, through the Assistant Secretary of Homeland Security for Health Affairs, to lead the federal government’s efforts to ensure the security of food, agriculture and veterinary systems against terrorism and other high-risk events, thus making this person responsible for coordinating the efforts of the Department of Homeland Security.

Medical countermeasures

Medical countermeasures (MCMs) are products such as biologics and pharmaceutical drugs that can protect from or treat the 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). It helps support "partner" agencies and organizations prepare for public health emergencies that could require MCMs. Its partners include government agencies at all levels of government, NGOs, universities, research centers, and FDA medical product centers. The federal government provides funding for MCM-related programs. In June 2016, a Senate Appropriations subcommittee approved a bill that would continue funding four specific medical countermeasure programs:

Challenges

The destruction of the World Trade Center in Manhattan on September 11, 2001 by terrorists and a subsequent wave of anthrax attacks on US media and government outlets (both real and hoax) led to increased attention on the risk of bioterrorism attacks in the United States. This led to increased funding to prepare for and respond to threats of bioterrorism. The US spent about $60 billion between October 2001 and September 2011.

In the October 2011 Bio-Response Report Card, the Center for the Study of Weapons of Mass Destruction (established in 1994 as the Center for Counterproliferation Research, as an outgrowth of the Defense Counterproliferation Initiative) stated that the major challenges to biosecurity were:
  • attribution
  • communication
  • detection and diagnosis
  • environmental cleanup
  • medical countermeasure availability
  • medical countermeasure development and approval process
  • medical countermeasure dispensing
  • medical management

Food and Drug Administration

From Wikipedia, the free encyclopedia

Logo of the United States Food and Drug Administration.svg
Agency overview
FormedJune 30, 1906
Preceding agencies
  • Food, Drug, and Insecticide Administration (July 1927 to July 1930)
  • Bureau of Chemistry, USDA (July 1901 through July 1927)
  • Division of Chemistry, USDA (established 1862)
JurisdictionFederal government of the United States
HeadquartersWhite Oak Campus
10903 New Hampshire Avenue
Silver Spring, Maryland 20993
39°02′07″N 76°58′59″WCoordinates: 39°02′07″N 76°58′59″W
Employees14,824 (2010)
Annual budget$3.16 billion (2020)
Agency executives
Parent agencyDepartment of Health and Human Services
Child agencies
Websitewww.fda.gov

The Food and Drug Administration (FDA or USFDA) is a federal 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 control 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), cosmetics, animal foods & feed and veterinary products.

The FDA was empowered by the United States Congress to enforce the Federal Food, Drug, and Cosmetic Act, which serves as the primary focus for the Agency; 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 regulating lasers, cellular phones, condoms 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. Stephen M. Hahn, MD is the acting commissioner, as of December 2019.

The FDA has its headquarters in unincorporated 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 began to post employees to foreign countries, including China, India, Costa Rica, Chile, Belgium, and the United Kingdom.

FDA Building 31 houses the Office of the Commissioner and the Office of Regulatory Department of Health and Human Services. The agency consists of fourteen Centers and Offices.

Organizational chart

Taha Kass-Hout (2014)

Location

Building 66 at the site of the former Naval Ordnance Laboratory
 
In recent years, the agency began undertaking a large-scale effort to consolidate its 25 operations in the Washington metropolitan area, moving from its main headquarters in Rockville and several fragmented office buildings to the former site of the Naval Ordnance Laboratory in the White Oak area of Silver Spring, Maryland. 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. Only one original building from the naval facility was kept. All other buildings are new construction. The project is slated to be completed by 2021, assuming future Congressional funding.

Regional facilities

The Arkansas Laboratory in Jefferson, Arkansas is the headquarters of the National Center for Toxicological Research

While most of the Centers are located in the Montgomery and Prince George's Counties in 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. There also a number of field locations across the United States in addition to international locations in China, India, Europe, Middle East, and Latin America. 

White Oak Campus is known as the “Federal Research Center” of the FDA. In total, the campus is 710 acres and separated by eight stream courses. This campus houses the Office of the Commissioner (OC), the Office of Regulatory Affairs (ORA),  the Center for Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH), the Center for Biologics Evaluation and Research (CBER) and offices for the Center for Veterinary Medicine (CVM).

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 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.

Jamaica, Queens, NY Regional Office - USFDA
 
The Office of Criminal Investigations was established in 1991 to investigate criminal cases. Unlike ORA Investigators, OCI Special Agents are armed, and don't focus on technical aspects of the regulated industries. OCI agents pursue and develop cases where individuals and companies have committed criminal actions, such as fraudulent claims, or knowingly and willfully shipping known adulterated goods in interstate commerce. In many cases, OCI pursues cases involving Title 18 violations (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 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. OCI is a smaller branch, comprising about 200 agents nationwide.

The FDA frequently works 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 with the FDA to provide regulatory inspections and enforcement action.

Scope and funding

The FDA regulates more than US$2.4 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 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.

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.

Regulatory programs

As of 2015, the agency regulates more than $1 trillion in consumer products, including:
  • $466 billion in food
  • $275 billion in drugs
  • $60 billion in cosmetics
  • $18 billion in vitamin supplements
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

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.

Canada-United States Regulatory Cooperation Council

On February 4, 2011, Prime Minister of Canada Stephen Harper and United States President Barack Obama 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".

Health Canada and the U.S. Food and Drug Administration (FDA) under the RCC mandate, undertook the "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)."

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 and interpreted by the FDA. Pursuant to the Federal Food, Drug, and Cosmetic Act ("the Act") 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 about both the composition and the health benefits of foods.

The FDA subdivides substances that it regulates as food into various categories—including foods, food additives, added substances (man-made substances that are not intentionally introduced into food, but nevertheless end up in it), and dietary supplements. 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 (DSHEA), the FDA is responsible for making sure 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 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. 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 (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 and pharmaceutical drugs that can protect from or treat the 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

FDA Building 51 houses the Center for Drug Evaluation and Research.

The Center for Drug Evaluation and Research 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 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 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). 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".

Some very rare limited exceptions to this multi-step process involving animal testing and controlled clinical trials can be granted out of compassionate use protocols, as was the case during the 2015 Ebola epidemic with the use, by prescription and authorization, of ZMapp 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.
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 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 refers to drug usage for indications other than those approved by the FDA.
Postmarket safety surveillance
After NDA approval, the sponsor must review and report to the FDA every 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 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 ("Risk Evaluation and Mitigation Strategies" or "REMS") for some drugs that require actions to be taken to ensure that the drug is used safely. For example, 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 drugs have REMS programs to avoid addiction and diversion of drugs. There is also a REMS program called iPLEDGE for the drug, isotretinoin.

Generic drugs

Generic drugs are chemical and therapeutical 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 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). 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, in 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. 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 like aspirin 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 like ibuprofen.

Ebola treatment

In 2014, the FDA added an 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 is seen as increasingly important in the face of a major outbreak of the disease in West Africa that began in late March 2014 and continued as of August 2014.

Coronavirus (COVID-19) testing

During the coronavirus pandemic, FDA granted Emergency Use Authorization for personal protective equipment (PPE), in vitro diagnostic equipment, ventilators and other medical devices.

On March 18, FDA inspectors postponed most foreign facility inspections and all domestic routine surveillance facility inspections. By contrast, the USDA's Food Safety and Inspection Service (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

FDA scientist prepares blood donation samples for testing

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 called a Biologics License Application (BLA), 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

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 neurostimulators. CDRH also oversees the safety performance of non-medical devices that 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.

"FDA-Cleared" vs "FDA-Approved"

Clearance requests are 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 it 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 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. 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, 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 (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 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.

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 2009, Congress passed a law requiring color warnings on cigarette packages and on printed advertising, in addition to 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, Lorillard, Commonwealth Brands Inc., Liggett Group LLC and Santa Fe Natural Tobacco Company Inc. have filed suit in Washington, D.C. federal court claiming that the graphic labels are an unconstitutional way of forcing tobacco companies to engage in anti-smoking advocacy on the government's behalf.

A First Amendment 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 and the 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 Richard Leon 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 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

The FDA cooperated with international regulatory and law enforcement agencies through Interpol as part of Operation Pangea XI from October 9 to October 16, 2018. The FDA targeted 465 websites that illegally sold potentially dangerous, unapproved versions of opioid, oncology and antiviral prescription drugs to U.S. consumers. In terms of money laundering, the FDA targeted transaction laundering schemes in order to uncover the complex online drug network.

Science and research programs

FDA lab at Building 64 in Silver Spring, Maryland
 
In addition to its regulatory functions, the FDA 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 decades. In March 2013, OpenFDA was created to enable easy access of the data for the public.

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 U.S. Department of Agriculture's Division of Chemistry, later its 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. 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 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, who had contracted tetanus.

Harvey W. Wiley, chief advocate of the Food and Drug Act

In June 1906, President Theodore Roosevelt signed into law the Pure 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 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 organization. This name was shortened to the Food and Drug Administration (FDA) three years later.

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 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 tragedy, in which over 100 people died after using a drug formulated with a toxic, untested solvent.

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. 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. These developments confirmed extensive powers for the FDA to enforce post-marketing recalls of ineffective drugs.

Medical Officer Alexander Fleming, M. D., examines a portion of a 240-volume new drug application around the late 1980s. Applications grew considerably after the efficacy mandate under the 1962 Drug Amendments.

Outside of the US, the drug 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, the 1962 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 (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 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, the 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 Virginia passed a law with limited effect in 1979, a more widespread trend began in California in 1996.

Historical first: FDA and Endo Pharmaceutical's Opana ER (2017)

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 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.

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 medicine medical 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.

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 postmarketing 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 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 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 1997 Food and Drug Administration Modernization Act to pass incentives that 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. 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 (HR 3580) signed by President George W. Bush signed the bill in September 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". In 2012, President Obama signed into law the FDA Safety and Innovation Act which includes Section 908 the "Rare Pediatric Disease Priority Review Voucher Incentive Program".

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, in essence 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.

Mobile medical applications

In 2013, a guidance was issued to regulate 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 such app has been proposed for expedite 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 $1.8 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. In addition, excessive regulation is blamed for the rising costs of health care and the creation of monopolies, as potential competitors are unable to get FDA approval to enter the market to compete and keep health care costs down.

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) 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.

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