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99-505: ARS conducts scientific research for the American public. Their main focus is on research to develop solutions to agricultural problems and provide information access and dissemination to: ARS research complements the work of state colleges and universities, agricultural experiment stations, other federal and state agencies, and the private sector. ARS research may often focus on regional issues that have national implications, and where there

198-477: A Toxoplasma gondii ( T. gondii ) research program, which experimented on cats infected with the parasite, from 1982 until 2018. The prevalence of T. gondii parasite has been reduced by 50% in the U.S. As of September 2018, which the ARS claims is a result of their research. The USDA has since discontinued the use of cats in their research amid acute accusations of animal abuse, and a lack of meaningful contribution to

297-618: A Biosafety Level 4 designation; in 2002, the US Congress again considered the plan. The Wall Street Journal reported in January 2002 that many scientists and government officials wanted the lab to close, believing that the threat of foot-and-mouth disease was so remote that the center did not merit its $ 16.5 million annual budget. In 2002, the Plum Island Animal Disease Center was transferred from

396-411: A United States Department of Homeland Security spokesperson in 2004, Building 257 was closed in 1995 and poses no health hazard. The structure is a 164,000-square-foot (15,200 m ) T-shaped white building. It is situated on Plum Island's northwest plateau on a 10-acre (40,000 m ) site where it is buttressed by a steep cliff which leads into the ocean. To the south-west of the building's site

495-743: A medical practitioner 's supervision like ibuprofen . 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 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. During

594-589: A quadruped of indeterminate size, was dead when discovered, and was assumed by some to have come from Plum Island as a result of the currents and proximity to the mainland. Palaeozoologist Darren Naish studied the photograph and concluded from visible dentition and the front paws that the creature may have been a raccoon . This was also the opinion of Larry Penny, the East Hampton Natural Resources Director. When American educated Pakistani neuroscientist Aafia Siddiqui ,

693-460: A "FDA Compliant" or "FDA Acceptable". Medical countermeasures (MCMs) are products such as biologics and pharmaceutical drugs 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

792-425: A REMS program called iPLEDGE . Generic drugs are chemical and therapeutic equivalents of name-brand drugs, normally 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

891-767: A case. 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. As of 2021, the FDA had responsibility for overseeing $ 2.7 trillion in food, medical, and tobacco products. Some 54% of its budget derives from the federal government, and 46% is covered by industry user fees for FDA services. For example, pharmaceutical firms pay fees to expedite drug reviews. According to Forbes, pharmaceutical firms provide 75% of

990-527: 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 regulation of drug advertising in the U.S. is divided between the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC), based on whether

1089-426: 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

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1188-536: A diagnostic facility, PIADC scientists study more than 40 foreign animal diseases , including classical swine fever and African swine fever . PIADC runs about 30,000 diagnostic tests each year. PIADC operates Biosafety Level 3 Agriculture (BSL-3Ag), BSL-3 and BSL-2 laboratory facilities. The facility's research program includes developing diagnostic tools and biologicals for foot-and-mouth disease and other diseases of livestock. Because federal law stipulates that live foot-and-mouth disease virus cannot be studied on

1287-432: 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

1386-594: A new lab facility, known as Building 101 , also began about this time but was not completed until September 1956. A modernization program in 1977 aimed to update both Building 257 and Building 101, but the program was canceled in 1979 because of construction contract irregularities. Plum Island facilities were essentially unchanged until a new modernization began in 1990. Two-thirds of the laboratory facilities inside Building 101 were renovated and operations in Building 257 were consolidated into Building 101. According to

1485-560: A new master plan for this expansion in December 2018, and construction is expected to be completed by 2035, dependent on GSA appropriations. The Office of Regulatory Affairs 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, warehousing facilities, investigate complaints, illnesses, or outbreaks, and review documentation in

1584-651: 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. The Office of Criminal Investigations 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

1683-415: A period of activations and deactivations through World War II until the U.S. Army Chemical Corps took over the facility in 1952 for use in anti-animal biological warfare (BW) research. The Chemical Corps planned a laboratory for the fort, to be housed in Building 257. The conversion of Fort Terry to a BW facility required the remodeling of Building 257 and other structures. As work neared completion on

1782-498: A role in monitoring safety through influence on ingredients, but they lack legal authority. According to the ACSH, it 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, or a clear definition of what 'safety' even means so that all chemicals get tested on the same basis. However, on December 29, 2022, President Biden signed

1881-523: A satisfied requirement. 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, but rather, they are

1980-440: 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.) The FDA's Office of Prescription Drug Promotion (OPDP) has responsibilities that revolve around the review and regulation of prescription drug advertising and promotion. This is achieved through surveillance activities and

2079-561: A warning to that effect. According to the industry advocacy group, the American Council on Science and Health , though the cosmetic industry is primarily responsible for its own product safety, the FDA can intervene when necessary to protect the public. In general, though, cosmetics do not require pre-market approval or testing. The ACSH says that companies must place a warning note on their products if they have not been tested, and that experts in cosmetic ingredient review also play

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2178-610: Is a federal agency of the Department of Health and Human Services . The FDA is responsible for protecting and promoting public health through the control and supervision of food safety , tobacco products, caffeine 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's primary focus

2277-441: Is a United States federal research facility dedicated to the study of foreign animal diseases of livestock . It is a national laboratory of the Department of Homeland Security (DHS) Directorate for Science and Technology (S&T), and operates as a partnership with the U.S. Department of Agriculture (USDA). The facility's director is Larry Barrett. Isolated on Plum Island off the eastern tip of Long Island , New York ,

2376-401: 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

2475-588: Is a clear federal role. ARS also provides information on its research results to USDA action and regulatory agencies and to several other federal regulatory agencies, including the Food and Drug Administration and the United States Environmental Protection Agency . ARS disseminates much of its research results through scientific journals, technical publications, Agricultural Research magazine, and other forums. Information

2574-651: 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 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

2673-697: Is also distributed through ARS's National Agricultural Library (NAL). ARS has more than 150 librarians and other information specialists who work at two NAL locations—the Abraham Lincoln Building in Beltsville, Maryland; and the DC Reference Center in Washington, D.C. NAL provides reference and information services, document delivery, interlibrary loan and interlibrary borrowing services to a variety of audiences. Prior to

2772-564: Is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C). However, the agency also enforces other laws, notably Section 361 of the Public Health Service Act as well as associated regulations. Much of this regulatory-enforcement work is not directly related to food or drugs but involves other factors like regulating lasers , cellular phones , and condoms . In addition, the FDA takes control of diseases in

2871-745: Is located in the White Oak area of Silver Spring, Maryland . The agency has 223 field offices and 13 laboratories located across 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 headquarters facilities are currently located in Montgomery County and Prince George's County , Maryland. Since 1990,

2970-717: Is located on Plum Island near the northeast coast of Long Island in New York state. During the Spanish–American War , the island was purchased by the government for the construction of Fort Terry , which was later deactivated after World War II and then reactivated in 1952 for the Army Chemical Corps . The center comprises 70 buildings (many of them dilapidated) on 840 acres (3.4 km ). Plum Island has its own fire department , power plant , water treatment plant, and security. Any wild mammal seen on

3069-449: 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

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3168-741: 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

3267-498: Is the old Plum Island Lighthouse . Construction on Plum Island's new laboratory Building 101 began around July 1, 1954, around the same time that the Army's anti-animal bio-warfare (BW) facilities at Fort Terry were transferred to the U.S. Department of Agriculture . Following the transfer, the facilities on Plum Island became known as the Plum Island Animal Disease Center. The USDA's $ 7.7. million Building 101 laboratory facility

3366-890: Is the world's largest agricultural research complex. Other D.C. area locations include the United States National Agricultural Library and the United States National Arboretum . ARS also has six major human nutrition research centers that focus on solving a wide spectrum of human nutrition questions by providing authoritative, peer-reviewed, science-based evidence. The centers are located in Arkansas, Maryland, Texas, North Dakota, Massachusetts (the Human Nutrition Research Center on Aging ), and California. ARS scientists at these centers study

3465-555: Is to be complete by 2023. The USDA has named former director of Canada's Centers for Animal Disease Alfonso Clavijo as the director of the new facility. PIADC's mission can be grouped into three main categories: diagnosis, research, and education. Since 1971, PIADC has been educating veterinarians in foreign animal diseases. The center hosts several Foreign Animal Disease Diagnostic schools each year to train federal and state veterinarians and laboratory diagnostic staff, military veterinarians and veterinary school faculty. At PIADC,

3564-702: 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 drugs receive extensive scrutiny before FDA approval in a process called a new drug application (NDA). Under the Presidency of Donald Trump , the agency has worked to make the drug-approval process go faster. Critics, however, argue that FDA standards are not sufficiently rigorous to prevent unsafe or ineffective drugs from getting approval. New drugs are available only by prescription by default. A change to over-the-counter (OTC) status

3663-451: 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 , called Phase IV trials. In some cases, the FDA requires risk management plans called Risk Evaluation and Mitigation Strategies (REMS) for some drugs that require actions to be taken to ensure that

3762-685: 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). With the passing of the FDA Reauthorization Act of 2017, the FDA projects a 64% increase in employees to 18,000 over the next 15 years and wants to add approximately 1,600,000 square feet (150,000 square metres) of office and special use space to their existing facilities. The National Capital Planning Commission approved

3861-539: The Department of Homeland Security (DHS), Building 257 currently poses no health hazard. Prolific but unfounded conspiracy theories have alleged that Lyme disease , first documented in nearby Lyme, Connecticut , was a biological weapon that originated in the Plum Island laboratory. A discredited 2004 book entitled Lab 257: The Disturbing Story of the Government's Secret Plum Island Germ Laboratory fueled

3960-1270: The U.S. National Poultry Research Center in Athens, Georgia . Other notable ARS facilities include Northern Great Basin Experimental Range in Oregon, and formerly the Plum Island Animal Disease Center off Long Island . Several ARS research units focus on pests, diseases, and management practices of horticultural crops. The Cereal Disease Laboratory is located on the campus of the University of Minnesota in Saint Paul . It primarily hosts research into rusts and Fusaria of cereals. The San Joaquin Valley Agricultural Sciences Center in Parlier, California conducts research on specialty crops including grapes, citrus, almonds, alfalfa, peaches, pomegranates, and many others. Several research locations throughout

4059-544: The U.S. program was ended by Richard Nixon in 1969. The bio-weapons research at Building 257 and Fort Terry was shrouded in aura of mystery and secrecy. The existence of biological warfare experiments on Plum Island during the Cold War era was denied for decades by the U.S. government. In 1993 Newsday unearthed documents proving otherwise and in 1994, Russian scientists inspected the Plum Island research facility to verify that these experiments had indeed ended. As

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4158-661: The US Army gave the island to the Agriculture Department to establish a research center dedicated to the study of foot-and-mouth disease in cattle. The island was opened to news media for the first time in 1992. In 1995, the Department of Agriculture was issued a $ 111,000 fine for storing hazardous chemicals on the island. Local Long Island activists prevented the center from expanding to include diseases that affect humans in 2000, which would require

4257-486: The United States Department of Agriculture to the United States Department of Homeland Security . In 2003, a whistleblower who voiced concerns about safety at the facility was fired by the contractor he worked for. He had discussed his concerns with aides to Senator Hillary Clinton . A National Labor Relations Board judge found that the contractor, North Fork Services, had discriminated against

4356-402: The United States Department of Agriculture . The FDA regulates tobacco products with authority established by the 2009 Family Smoking Prevention and Tobacco Control Act . This Act requires color warnings on cigarette packages and printed advertising, and text warnings from the U.S. Surgeon General . Plum Island Animal Disease Center Plum Island Animal Disease Center ( PIADC )

4455-581: The United States' offensive bioweapons program . Today the facility maintains laboratories up to biosafety level 3 , and has remained controversial as a result of its high-risk work and proximity to the New York metropolitan area . The facility is slated for closure in 2024 , with work moving to the National Bio and Agro-Defense Facility under construction in Manhattan, Kansas . The center

4554-643: 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, 2020, FDA inspectors postponed most foreign facility inspections and all domestic routine surveillance facility inspections. In 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. The Center for Biologics Evaluation and Research

4653-443: The mainland , PIADC is unique in that it is currently the only laboratory in the U.S. equipped with research facilities that permit the study of foot-and-mouth disease . Foot-and-mouth disease is extremely contagious among cloven-hooved animals, and people who have come in contact with it can carry it to animals. Accidental outbreaks of the virus have caused catastrophic livestock and economic losses in many countries throughout

4752-606: The '2023 Consolidated Budget Act', which includes the 'Cosmetics Regulatory Modernization Act of 2022 (MoCRA)', which is a stricter regulation that is different from the previous regulations. MoCRA requires compliance with matters such as serious adverse event reporting, safety substantiation, additional labeling, record keeping, and Good Manufacturing Practices (GMP). MoCRA also calls on the FDA to grant Mandatory Recall Authority and establish regulations for GMP rules, flavor allergen labeling rules, and testing methods for cosmetics containing talc. The Center for Veterinary Medicine (CVM)

4851-406: 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 (ANDA). 80% of prescription drugs sold in

4950-511: The FD&C Act. OCI Special Agents often come from other criminal investigations backgrounds, and frequently 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

5049-633: 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 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

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5148-724: The FDA has had employees and facilities on 130 acres (53 hectares) of the White Oak Federal Research Center in the White Oak area of Silver Spring, Maryland . In 2001, the General Services Administration (GSA) began new construction on the campus to consolidate the FDA's 25 existing operations in the Washington metropolitan area , its headquarters in Rockville , and several fragmented office buildings. The first building,

5247-713: 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 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,

5346-594: The FDA's drug review budget 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. The programs for safety regulation vary widely by the type of product, its potential risks, and

5445-881: 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 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 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 additives , added substances (human-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

5544-850: The Foreign Animal Disease Diagnostic Laboratory, an internationally recognized facility performing diagnostic testing of samples collected from U.S. livestock. APHIS also tests animals and animal products being imported into the U.S. APHIS maintains the North American Foot-and-Mouth Disease Vaccine Bank at PIADC and hosts the Foreign Animal Disease Diagnosticians training program, offering several classes per year to train veterinarians to recognize foreign animal diseases. Research on biological weapons at PIADC ceased when

5643-647: 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 3,800,000 square feet (350,000 square metres) of space, divided into ten offices and four laboratory buildings. The campus houses the Office of the Commissioner (OC), the Office of Regulatory Affairs (ORA), 

5742-566: The Plum Island Animal Disease Research Center will be replaced by a new federal facility. The location of the new high-security animal disease lab, called the National Bio and Agro-Defense Facility (NBAF), is being built in Manhattan, Kansas . The plan was controversial almost immediately when it was unveiled, following a cost assessment by DHS and prime contractor Booz Allen Hamilton in which

5841-1058: The U.S. Department of Homeland Security (DHS) and U.S. Department of Agriculture (USDA) work together; DHS' Targeted Advanced Development unit partners with USDA, academia and industry scientists to deliver vaccines and antivirals to the USDA for licensure and inclusion in the USDA National Veterinary Vaccine Stockpile. USDA Agricultural Research Service (ARS) performs basic and applied research to better formulate countermeasures against foreign animal diseases, including strategies for prevention, control and recovery. ARS focuses on developing faster-acting vaccines and antivirals to be used during outbreaks to limit or stop transmission. Antivirals prevent infection while vaccine immunity develops. The principal diseases studied are foot-and-mouth disease , classical swine fever , and vesicular stomatitis virus . USDA Animal and Plant Health Inspection Services (APHIS) operates

5940-675: The US also house germplasm collections of plant species important for agricultural and industrial uses as part of the National Genetic Resources Program . From the very beginning the Department of Agriculture and in turn the Agricultural Research Service has been focused on improving not only the farming industry but also the quality of food and the health of Americans. In 1985, technology to produce lactose-free milk, yogurt, and ice cream

6039-571: The United States Biological Warfare program was ended in 1969 by President Richard Nixon . The original anti-animal biological weapons mission was "to establish and pursue a program of research and development of certain anti-animal (BW) agents". By August 1954 animals occupied holding areas at Plum Island and research was ongoing within Building 257. The USDA facility, known as the Plum Island Animal Disease Center, continued work on biological warfare research until

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6138-488: The United States are generic brands. 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

6237-405: The agency determined that the cost of maintaining or moving the facility would be comparable. Those conclusions, as well as claims about the safety of the facility proposed were called into question several times, first by a 2007 Government Accountability Office study, which stated that claims by DHS that the work on foot and mouth disease performed on Plum Island can be performed "as safely on

6336-784: 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 , Customs and Border Protection , and the Consumer Product Safety Commission . They also often work with local and state government agencies in performing regulatory inspections and enforcement actions. The regulation of food and dietary supplements by

6435-468: 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. Clearance requests are required for medical devices that prove they are "substantially equivalent" to

6534-478: 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. The districts are based roughly on the geographic divisions of the Federal court system . Each district comprises a main district office and

6633-444: The center has been tasked with protecting America's livestock from animal diseases since 1954. It is the only facility in the country authorized to work with live foot-and-mouth disease (FMD) samples, and specializes in the study of FMD and African swine fever . At the height of the Cold War , study of biological weapons for use against livestock was conducted at the site, ending in 1969 when President Nixon declared an end to

6732-536: The center's safety: "We urge you to immediately investigate these alarming breaches at the highest levels, and to keep us apprised of all developments." Building No. 257 at Fort Terry , on Plum Island near Long Island , New York, was completed around 1911. The original purpose of the building was to store weapons, such as mines, and the structure was designated the Combined Torpedo Storehouse and Cable Tanks building. Fort Terry went through

6831-584: The conspiracy theories. Archived specimens show that Lyme disease was endemic well before the establishment of Plum Island laboratory. Additionally, Lyme disease was never a topic of research at Plum Island, according to the US Department of Homeland Security and Department of Agriculture. On July 12, 2008, a creature dubbed the Montauk Monster washed ashore at Ditch Plains Beach near the business district of Montauk, New York . The creature,

6930-402: The contexts varying from household pets to human sperm donated for use in 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 . Robert Califf is the current commissioner as of February 17, 2022. The FDA's headquarters

7029-420: The drug in question is a prescription drug or an over-the-counter (OTC) drug. The FDA oversees the advertising of prescription drugs, while the FTC regulates the advertising of OTC drugs. The term off-label refers to the practice of prescribing a drug for a different purpose than what the FDA approved. Due to this approval requirement, manufacturers were prohibited from advertising COVID-19 vaccines during

7128-416: 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. The drug isotretinoin has

7227-696: 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 (OTC) are drugs like 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

7326-648: 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

7425-436: The federal government. It helps support "partner" agencies and organisations prepare for public health emergencies that could require MCMs. 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,

7524-646: The field in recent years (only three of thirteen papers published about T. gondii by the ARS were published after the year 2000). More recently, the ARS has focused research on genetics and plant and animal DNA. Their research has developed pest-resistant corn, faster growing plants and fish, and a focus on plant and animal genome research and mapping. Outside of scientific research, the ARS has worked to release databases on food components in order to assist consumers with making informed decisions about food choices. Food and Drug Administration The United States Food and Drug Administration ( FDA or US FDA )

7623-437: The first time. Plum Island has experienced outbreaks of its own, including one in 1978 in which foot-and-mouth disease was released to animals outside the center, and two incidents in 2004 in which the disease was released within the center. In response to the two 2004 incidents, New York Senator Hillary Clinton and Congressman Tim Bishop wrote a letter to the Department of Homeland Security regarding their concerns about

7722-483: The inception of ARS, agricultural research was first conducted under the umbrella of the Agricultural Department in the U.S. Patent Office in 1839. It was created to collect statistics, distribute seeds and compile and distribute pertinent information. In 1862 the USDA was created and agricultural research was moved to its department. That same year, the department issued its first research bulletin on

7821-400: The island because of its extensive wildlife habitats. After the final draft of the legislation was announced, Schumer said “It would have been a grave mistake to sell and develop Plum Island's 840-acres of habitat, which is home to many endangered species, that's why preventing the unnecessary sale requirement was a top priority of these negotiations." On September 11, 2005, DHS announced that

7920-551: The island is killed to prevent the possible transmission of foot-and-mouth disease. However, as Plum Island was named an important bird area by the New York Audubon Society , it has attracted different birds. Plum Island has placed osprey nests and bluebird boxes throughout the island. As of 2008 , new kestrel houses were planned to be added. In response to disease outbreaks in Mexico and Canada in 1954,

8019-555: The issuance of enforcement letters to pharmaceutical manufacturers. Advertising and promotion for over-the-counter drugs is regulated by the Federal Trade Commission . The FDA also implements regulatory oversight through engagement with third-party enforcer-firms. It expects pharmaceutical companies to ensure that third-party suppliers and labs comply with the agency's health and safety guidelines . The drug advertising regulation contains two broad requirements: (1)

8118-489: The lab and other facilities in the spring of 1954 the mission of Fort Terry changed. Construction was completed on the facilities on May 26, 1954, but the post was transferred to the USDA before the military could utilize the new laboratory facilities. Fort Terry was officially transferred to the USDA on July 1, 1954, at the time scientists from the Bureau of Animal Industry were already working in Building 257. Construction on

8217-533: The mainland" is "not supported" by evidence. In 2012, DHS completed a risk assessment of the Kansas site that called the proposed facility "safe and secure". In response, a 2012 review of the risk assessment by the National Research Council called it "seriously flawed". Despite controversy, the new facility is nearing completion, and transfer of laboratory contents from Plum Island to NBAF

8316-533: The period in which they had only been approved under Emergency Use Authorization . 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 program. These reports are called "spontaneous reports" because reporting by consumers and health professionals

8415-422: 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 are regulated by the Center for Food Safety and Applied Nutrition ,

8514-438: The program was canceled in 1979 because of construction contract irregularities. PIADC facilities were essentially unchanged until a new modernization began in 1990. Two-thirds of the laboratory facilities inside Building 101 were renovated and operations from Building 257 were consolidated into Building 101. Building 257 was closed, and a major expansion, known as Building 100, was completed on Building 101 in 1995. According to

8613-580: 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 (e.g., conspiracy, false statements, wire fraud, mail fraud), in addition to prohibited acts as defined in Chapter III of

8712-470: 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,

8811-658: The role of food and dietary components in human health from conception to advanced age. The ARS also offers the Culture Collection, which is the largest public collection of microorganisms in the world, containing approximately 93,000 strains of bacteria and fungi. The ARS Culture Collection is housed at the National Center for Agricultural Utilization Research (NCAUR) ARS operates the U.S. Horticultural Research Laboratory in Fort Pierce, Florida , and

8910-448: 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. 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

9009-458: 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

9108-431: The sugar content of grape varietals and their suitability for wine. Six years later the USDA would begin its first research on animal diseases, specifically hog cholera, which was causing devastating losses at the time. In the early 1900s the USDA began analyzing food composition and the first studies of nutrition and the effects of cooking and processing foods were conducted. Finally, in 1953 the Agricultural Research Service

9207-460: The whistleblower. In 2020, the Department of Homeland Security plan to put the island up for auction after the conclusion of laboratory activities in 2023 was blocked by Congress. As part of ongoing COVID-19 pandemic relief legislation, Senator Chuck Schumer of New York negotiated a provision in the CARES Act that protects the island from being sold. Environmentalists had opposed the sale of

9306-471: The world. Foot-and-mouth disease was eradicated from the U.S. in 1929 (with the exception of the stocks within the Plum Island center) but is currently endemic to many parts of the world. In 2012, two researchers at the facility, John Neilan and Michael Puckette, developed the first Foot-and-mouth disease vaccine which does not require live virus cultures in the manufacturing process, allowing vaccine development to occur safely and legally on U.S. mainland for

9405-778: Was created to be the USDA's primary scientific research agency. ARS supports more than 2,000 scientists and post docs working on approximately 690 research projects within 15 National Programs at more than 90 research locations. The ARS is divided into 5 geographic areas: Midwest Area, Northeast Area, Pacific West Area, Plains Area, and Southeast Area. ARS has five major regional research centers: The research centers focus on innovation in agricultural practices, pest control, health, and nutrition among other things. Work at these facilities has given life to numerous products, processes, and technologies. ARS' Henry A. Wallace Beltsville Agricultural Research Center (BARC) in Beltsville, Maryland ,

9504-525: Was dedicated on September 26, 1956. Prior to the building's opening the area around it was sprayed with chemicals to deter insect or animal life from approaching the facility. Upon its opening a variety of tests using pathogens and vectors were conducted on animals in the building. Research on biological weapons at PIADC did not cease until the entire program was canceled in 1969 by Richard Nixon . A modernization program in 1977 aimed to update both Building 101 and another laboratory, Building 257 , but

9603-482: Was developed through the Agricultural Research Service. The grape breeding program, currently located in Parlier, CA which began in 1923, developed seedless grapes and continues to release new grapevine varieties with improved traits. The ARS Citrus and Subtropical Products Laboratory in Winter Haven, Florida, actively works to improve the taste of orange juice concentrate. The Agricultural Research Service had

9702-533: 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

9801-543: 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. The Center for Devices and Radiological Health (CDRH)

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