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Food and Drug Administration

FOOD AND DRUG ADMINISTRATION

One of the oldest U.S. consumer protection agencies, the Food and Drug Administration (FDA) protects the public from unsafe foods, drugs, medical devices, cosmetics, and other potential hazards. As part of the department of health and human services, the FDA annually regulates over $1 trillion worth of products, which account for one-fourth of all consumer spending in the United States. It also protects the rights and safety of patients in clinical trials of new medical products, monitors the promotional activities of drug and device manufacturers, regulates the labeling of all packaged foods, and monitors the safety of the nation's blood supply.

To ensure compliance with its regulations, the FDA employs over 1,000 investigators and inspectors who visit over 15,000 food-processing, drug-manufacturing, and other facilities each year. If it finds violations of law, the FDA first encourages an offending company to voluntarily correct the problem or to recall a faulty product from the market. If the firm does not voluntarily comply with the law, the FDA may take it to court and seek criminal penalties against it. The FDA may also seize faulty products, order product recalls, seek injunctive relief, impose fines, and take other types of enforcement action. Each year, the FDA declares about 3,000 products and 30,000 import shipments to be unacceptable in various ways.

The FDA employs over 2,000 scientists—including 900 chemists and 300 microbiologists—who provide the scientific evidence to back up its regulatory and inspection duties. These scientists analyze samples of products for purity and review test results of new products. The FDA itself does not do research for a new medical product. Instead, it evaluates the results of studies undertaken by the manufacturer.

History

Food production in the United States has been regulated since the late eighteenth century. Colonies and, later, states passed laws banning impurities from selected foods. In 1848, the United States began regulating imported drugs, under the Drug Importation Act (Ch. LXX, 9 Stat. 237). The enforcement of food and drug laws was first assigned to the Chemical Division of the new u.s. department of agriculture (USDA) in 1862 (12 Stat. 387).

The need for laws to regulate food and drug purity became increasingly urgent in the late nineteenth century, when substances such as opium, cocaine, and heroin were commonly added to medicinal elixirs and tonics. The need for government regulation was also made evident in Upton Sinclair's book, The Jungle, which exposed the unsanitary conditions of Chicago's meatpacking industry and shocked the nation. On June 30, 1906, Congress, with the support of President theodore roosevelt, passed two landmark pieces of Progressive Era legislation that strengthened the government's ability to protect consumers: the Food and Drug Act (34 Stat. 768 [21 U.S.C.A. § 1–15]) and the Meat Inspection Act (21 U.S.C.A. § 601 et seq.). The former prohibited interstate commerce in misbranded and adulterated foods, drinks, and drugs, and the latter addressed the unsanitary conditions and use of poisonous preservatives and dyes in the meatpacking industry.

In 1927, Congress authorized the creation of the Food, Drug, and Insecticide Administration within the U.S. Department of Agriculture. In 1930, the agency's name was changed to the current one, Food and Drug Administration (Agriculture Appropriation Act, 46 Stat. 976).

In 1937, 107 people died after taking the elixir sulfanilamide, a supposedly healing tonic. This tragedy prompted the passage of the next major reform of food and drug law, the Federal Food, Drug, and Cosmetic Act of 1938 (21U.S.C.A. § 301 et seq.). The FDA was then entrusted with the regulation of cosmetics and therapeutic devices and was authorized to do factory inspections. Even more importantly, the act required new drugs to be tested on animals and humans for safety before being marketed. In 1957, the Food Additives Amendment (Pub. L. 85-250, Aug. 31, 1957, Stat. 567) required the evaluation of food additives to establish safety, and in the following year, the Delaney Clause (Pub. L. 85-929, Sept. 6, 1958, 72 Stat. 1784) forbade the use in food of substances found to cause cancer in laboratory animals.

How the FDA Approves New Drugs

The process by which the Food and Drug Administration (FDA) approves drugs as safe and effective is generally long and complicated, though it may vary according to the type of drug and the nature of the illness for which it is being developed. The FDA refers to drugs under development as investigational new drugs, or INDs.

The evaluation of new drugs requires the skills of many different FDA scientists and professionals performing a wide variety of tasks. Biochemists and molecular biologists evaluate the basic chemistry and biology of new chemical compounds and molecular structures. Toxicologists assess the potential harm of proposed drugs, and pharmacologists study how these drugs affect the body and are broken down and absorbed by it. Computer scientists create electronic models that aid in the understanding of new chemicals. Physicians evaluate the results of clinical trials, assessing both the beneficial and adverse effects of the drugs. And statisticians evaluate the design and results of controlled studies.

It is an expensive and time consuming process, particularly for the company developing the drug, called a drug sponsor. A sponsor spends an average of $359 million for each new drug brought to market. Typically, the process takes eight and a half years and may be divided into roughly three stages: preclinical trials, involving animal and other laboratory tests (lasting one and a half years on average); clinical trials, involving tests on humans (five years); and FDA review (two years).

Preclinical Trials Once a sponsor has developed a drug, it must test the drug on animals in the laboratory. In doing so, the drug sponsor must follow FDA guidelines and regulations. These tests, also called preclinical trials, are usually done on more than one species of animals. FDA guidelines call for the inspection of animal laboratories every two years to ensure that they are being operated according to the administration's regulations.

After short-term lab testing has been performed and the sponsor has deemed its results adequate, the sponsor submits test data and plans for future clinical trials to the FDA. FDA scientists, together with a local institutional review board composed of scientists, ethicists, and nonscientists, then conduct a thirty-day safety review to decide whether to allow testing on humans. The vast majority of new drugs tested in the laboratory are rejected by either the sponsor or the FDA because they are unsafe or ineffective.

If the FDA indicates approval, the drug sponsor may begin clinical testing on humans. Even if a drug is approved for clinical trials, the sponsor continues animal testing of the drug in order to better understand the drug's long-term effects.

Clinical Trials Clinical trials are scientifically controlled studies in which the drug being tested is given to one group of patients, while another treatment, often a placebo (an inactive substance that looks like the drug being tested), is given to another group. Ideally, neither group of patients knows which is receiving the new drug and which is receiving the placebo.

The clinical trials, like the animal tests, examine what happens to the drug in the body, including whether it is changed, or metabolized, in the body, how much of it is absorbed into the blood, and how long it remains in the body. If human tests produce unexpected results, researchers may conduct further animal tests to better understand the drug.

Clinical trials proceed in three phases: Phase 1 involves testing primarily for safety and dosage level. Twenty to one hundred healthy patients are assessed over several months. If the results are within FDA safety guidelines, the trials proceed to phase 2.

Phase 2 involves a greater number of patients—up to several hundred—who have the condition that the drug is intended to treat. During this stage, which lasts from several months to two years, researchers attempt to determine the drug's effectiveness in achieving its stated purpose, as well as its safety. At the end of this phase, sponsors meet with FDA officials to discuss the best way to conduct the next phase of testing.

In phase 3, the most crucial stage of testing, the number of patients is expanded still further, to several hundred to several thousand, and the length of the study is increased to one to four years. This phase establishes the correct dosage of the drug and how it will be labeled, and provides further evidence regarding its safety and effectiveness.

Of one hundred drugs submitted for testing in humans, an average of seventy will pass phase 1. Of these seventy, on average, only thirty-three will remain after phase 2 testing, and twenty-five to thirty after phase 3. Finally, an average of only twenty will actually receive FDA approval.

Once the drug sponsor has completed clinical trials, it submits a new drug application (NDA) to the FDA, requesting approval to market the drug. This application consists of documentation detailing the chemical composition of the drug, the design of the trials, the results of the trials, and the means by which the drug is made and packaged.

FDA Review In assessing an NDA, the FDA undertakes its closest scrutiny of all during the drug approval process. Its principal goal during review is to determine whether the benefits of the new drug outweigh the risks. To reach this determination, the FDA examines the documentation provided by the sponsor and looks at samples of the drug.

If inadequacies are discovered in the NDA, the FDA may require additional information, further testing, or modified labeling. In cases where it is difficult to establish clearly whether the benefits of the drug outweigh the risks, a panel of outside experts is often consulted.

If the FDA approves the drug, the sponsor may begin manufacturing and marketing the drug immediately.

The FDA does not stop monitoring a drug once it has been marketed. It continues to evaluate the drug's safety and effectiveness through its program of postmarket surveillance. This program consists of surveys, the testing of product samples, and the analysis of reported adverse reactions.

Speeding Drugs to Those Who Need Them The FDA has longstanding policies allowing what it calls the compassionate use of new drugs for those in desperate need. Innovative cancer treatments, for example, have been made available to patients since the 1970s through the National Cancer Institute.

However, during the 1980s, the FDA came under increasing fire for its slow approval of new drugs. Particularly with the emergence of AIDS during the 1980s, the public outcry for fast delivery of innovative new drugs strengthened. As science produces ever more pharmaceuticals, the FDA is called on to review drug applications as quickly as is reasonably possible.

In response to the growing demand for speedy drug evaluation, the FDA has made significant changes in its review protocols. In 1987, for example, the agency adopted "expanded access" regulations, which permit certain drugs to be designated as treatment INDs. A treatment IND may be administered to patients even while it is still undergoing clinical trials. This program allows patients with no other alternatives to undergo a treatment that may benefit their health. By August 1994, twenty-nine agents had been designated treatment INDs, and by 1995, more than seventy-five thousand patients had received access to new therapies through this program. New drugs used to treat patients with AIDS are made available through a similar process known as the parallel track approach.

Identifying priorities is another method the FDA uses to provide more rapid access to promising new treatments. AIDS drugs, drugs that treat life-threatening or severely debilitating illnesses, and drugs that appear to offer significant improvements over existing therapies are classified as priority drugs and receive faster review than those classified as standard drugs. With priority drugs, the FDA typically becomes involved earlier in the development process, and is thereby able to more quickly review the relevant applications.

Drugs are also classified as to chemical type, so that those closely similar in structure to existing drugs will receive less intensive review than those with a molecular structure that has never been marketed before.

Accelerated approval is another mechanism for faster review of promising new drugs. Under this program, created in 1991, a product may be approved for limited use if it has been shown in trials to achieve particular results—such as lowering blood pressure or cholesterol. Drugs approved under this program include didanosine for AIDS, interferon beta-1B for multiple sclerosis, and DNase for cystic fibrosis.

The Prescription Drug User Fee Act of 1992 (Pub. L. 102-571, Title 1, Oct. 29, 1992, 106 Stat. 4491 to 4500) has also enabled the FDA to speed drug review. Under this law, fees paid by drug manufacturers are used by the agency to hire hundreds of additional review staff and buy improved equipment, including computers that make review more efficient.

The FDA is also attempting to streamline red tape and bureaucracy. In 1995, President bill clinton and Vice President albert gore, Jr., announced that twenty-one separate product license applications used by the FDA would be consolidated into one simplified form. This form would also be available in an electronic format, making it easier to distribute, prepare, and review.

Results indicate that these changes have led to faster approval of important new drugs. One signal success of FDA reform was the prompt approval of taxol, a treatment for advanced ovarian cancer that was approved in December 1992 after a record 5 months. By 1994, all new drugs were being approved by the FDA in a median time of 19 months, and priority drugs with important therapeutic uses were approved in an average of 10.4 months. In the late 1980s, by comparison, the FDA took an average of 27 months to approve new drugs.

In 1995, President Clinton established even more ambitious new goals for FDA approval. These goals, to be met by 1997, require the FDA to approve priority drugs within 6 months and standard drugs within 12 months.

In 1962, the Kefauver-Harris Drug Amendments (Pub. L. 87-781, Oct. 10, 1962, 76 Stat.780) were passed. These laws required drug manufacturers not only to show that their drugs were safe but also to prove that their drugs achieved the effects claimed. That same year, FDA regulations were shown to be effective after the drug thalidomide, for which the FDA had delayed approval, caused thousands of birth defects in western Europe.

In 1979, the FDA was made part of the Department of Health and Human Services (96 Stat. 668, 695). Other laws with major implications for the FDA's activities include the 1990 Nutrition Labeling and Education Act (Pub. L. 101-535, Nov. 8, 1990, 104 Stat. 2353), which requires all packaged foods to carry labels with nutrition information, and the Prescription Drug User Fee Act of 1992 (Pub. L. 102-571, Title 1, Oct. 29, 1992, 106 Stat. 4491 to 4500), which requires drug and biologics manufacturers to pay fees that support FDA assessment of their products.

Effective October 2002, the FDA implemented its National Organic Program (NOP) under the Organic Foods Production Act of 1990 (OFPA), 7 U.S.C. 6501 et. seq. The NOP sets the first national standards for the use of the label term organic on food items and products. Products that qualify as "100 percent organic" under NOP rules may use the "USDA Organic" seal on their principal display panel. The rules specifically prohibit the use of genetic engineering methods, ionizing radiation (irradiation), and sewage sludge for fertilization. In addition, all agricultural products that are labeled organic must originate from farms or handling operations that have been certified by a state or private agency accredited by the USDA.

Organization

The FDA carries out its activities through a number of subdivisions. The Center for Drug Evaluation and Research regulates the safety, effectiveness, and labeling of all prescription and over-the-counter drugs intended for human use. It also monitors drug advertising for accuracy, ensures the safety and rights of patients in drug studies, and distributes information on drug products to the medical community and the public.

The Center for Biologics Evaluation and Research regulates biological products, which include blood, vaccines, human tissues, and drugs derived from living organisms. It coordinates an AIDS program, which works to develop an AIDS vaccine and AIDS diagnostic tests. It also conducts research on the safety of blood and blood products and inspects manufacturing plants to ensure compliance with FDA standards.

The Center for Food Safety and Applied Nutrition develops regulations related to food, food additives and colorings, and cosmetics. The Center for Devices and Radiological Health seeks to ensure the safe use of potentially hazardous radiation such as that produced by X rays. It conducts research into the effects of exposure to radiation-producing medical devices and develops manufacturing standards for such devices.

The Center for Veterinary Medicine evaluates the safety of drugs and devices used on animals. The National Center for Toxicological Research assesses the biological effects of toxic chemical substances.

AZT: An Agent of Change for the FDA

Azidothymidine (AZT) is a celebrated example of speedy FDA approval of a new drug. The unusually swift approval of AZT during the early years of the AIDS (acquired immune deficiency syndrome) epidemic led to the creation of a new FDA category, treatment investigational new drug (treatment IND), that established new procedures for more rapid and flexible drug approval.

The pharmaceutical company Burroughs Wellcome first presented AZT as a new drug to the FDA in June 1985. Public fear of AIDS had increased dramatically during the previous few years, as had protests by AIDS activists who complained of slow FDA movement with regard to promising new treatments. Keenly aware of the need for swift decision making in the face of the deadly AIDS disease, the FDA approved phase 1 clinical trials of the drug within one week of the initial application.

Phase 1 testing of AZT, between July and December 1985, was promising, and phase 2, involving 300 patients in placebo-controlled trials, began in February 1986. After six months, 19 of the 137 patients in the group taking the placebo had died, whereas only 1 of 145 in the group taking AZT had died. The results were encouraging enough for the FDA to forgo further testing. The group taking the placebo was switched to AZT, and phase 3 testing, traditionally the most important step in clinical trials, was deemed unnecessary.

In September 1986, the FDA authorized the treatment of patients who wanted access to AZT, even before it had given approval to the drug. By the time approval for general public use came in March 1987, some 4,000 patients had already been treated with AZT, and thus the drug was already potentially extending the lives of hundreds of people.

Taking an example from its handling of AZT, the FDA in May 1987 created the treatment IND classification to facilitate faster approval and wider distribution of promising new therapies for life-threatening diseases. The rapid approval of AZT also proved greatly encouraging to the pharmaceutical industry, which could now hope to bring AIDS drugs to market much more rapidly and at lower cost.

cross-references

Acquired Immune Deficiency Syndrome.

Other offices of the FDA include the Office of Policy, the Office of External Affairs, the Office of Management and Systems, the Office of AIDS Coordination, the Office of Orphan Products Development, and the Office of Biotechnology. The administration operates six field offices, 21 district offices, and 135 resident inspection posts throughout the United States and Puerto Rico.

further readings

Branding, Frederick H. 2003. "Preparing for and Surviving FDA Inspections." Corporate Counsel's Quarterly 19 (January): 28–35.

Burkholz, Herbert. 1994. The FDA Follies. New York: Basic Books.

"Center for Drug Evaluation and Research." 1995. U.S. Food and Drug Administration (March 14). Available online at <www.fda.gov> (accessed March 13, 2003).

Clinton, Bill, and Al Gore. 1995. Reinventing Drug and Medical Device Regulations. National Performance Review series (April). Washington, D.C.: U.S. Government Printing Office.

——. 1995. Reinventing the Regulation of Drugs Made from Biotechnology. National Performance Review series (November). Washington, D.C.: U.S. Government Printing Office.

"FDA Mission Statement: Protect Public Health." 1995. U.S. Food and Drug Administration (March 30). Available online at <www.fda.gov> (accessed March 13, 2003).

Harmon, Daniel E. 2002. The Food and Drug Administration. Philadelphia: Chelsea House Publishers.

"Milestones in U.S. Food and Drug Law History." 1995. U.S. Food and Drug Administration (August). Available online at <www.fda.gov> (accessed March 13, 2003).

Parver, Deborah G. 1999. "Expediting the Drug Approval Process: An Analysis of the FDA Modernization Act of 1997." Administrative Law Review 51 (fall): 1249–66.

U.S. Food and Drug Administration. 1995. FDA Consumer: From Test Tube to Patient: New Drug Development in the United States. 2d ed. Washington, D.C.: U.S. Food and Drug Administration.

U.S. Food and Drug Administration Website. Available online at <www.fda.gov>.

U.S. Government Manual Website. Available online at <www.gpoaccess.gov> (accessed November 10, 2003).

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Food and Drug Administration

FOOD AND DRUG ADMINISTRATION

FOOD AND DRUG ADMINISTRATION. The Food and Drug Administration (FDA) was the first regulatory agency established in the United States with consumer protection as its principal mission. Arguably, it is the only federal regulatory agency today whose basic charge has not been substantially altered in nearly one hundred years. Although the agency's responsibilities have grown enormously since Congress first defined food and drug adulterations as a danger to health and as consumer fraud in 1906, FDA remains a science-based regulatory agency responsible for protecting the public health through the regulation of foods, drugs, biological therapeutic products (i.e., vaccines), medical devices, cosmetics, animal feed, and radiation-emitting consumer products.

FDA began as a small, analytical chemistry unit in the U.S. Department of Agriculture, created after the Civil War to promote agriculture and assist farmers. A single chemist, whose job it had been to analyze fertilizers and agricultural chemicals for the Patent Office, was transferred to the new department in 1862 to continue his work on behalf of farmers and state agricultural extension services. In 1880, the chief chemist in the Bureau of Chemistry endorsed passage of a federal food and drug law, and his successor in 1883, Harvey W. Wiley, actively campaigned for the law. When it was finally enacted by Congress in 1906, the Pure Food and Drugs Act was often referred to as the Wiley Act.

Wiley led the bureau in an era in which the transforming trilogy of industrialization, immigration, and urbanization changed America from a nation of farmers into a nation dominated by business. The earliest successful commercial foods were either new altogether—like crackers—or tasty but time-consuming to prepare at home. Condiments such as mustard, catsup, relishes, jams, and jellies, and, later, tinned fruits, meats, and vegetables, were all newly available from a burgeoning prepared foods industry. Likewise, medicines for the inevitable indigestion (dyspepsia) and other ills stemming from a poor diet were some of the most successful patent medicines. Consumers, however, had little way of telling good products from bad. State laws were frequently inconsistent and ineffective. Meanwhile, canned foods exploded, patent medicines and standard drugs were often equally unreliable, catsups fermented, and mustards were often watered down. Even products labeled "pure" were often counterfeits; most "pure Vermont maple syrup," for instance, was made from Iowa corn syrup.

The Bureau of Chemistry found its niche in the Department of Agriculture by using its analytical chemical expertise to improve the U.S. marketplace. Wiley and the bureau chemists turned their attention to the food and drug products on the market, testing them for ingredient substitutions, omissions, or additions that would be defined as "adulteration" and "misbranding," under the 1906 act. Wiley's pioneering work on the safety of food preservatives led Congress to increase his bureau's budget and include special funds for human testing of early food additives (salicylic acid, benzoate of soda, boric acid, copper salts, saccharin). As it became clear that some producers would always take shortcuts to reduce costs (so long as the consumer could not detect the difference), support for a national food and drug law began to emerge and grow, supported by national women's groups, muck-raking journalists, state food and drug officials, and analytic chemists. Wiley's prowess as a "crusading chemist" became legendary. At a convention of hostile canners, for example, he single-handedly changed their minds about regulation by reminding them that what they made they should also be willing to eat.

At the height of Progressive-era politics, during the heyday of analytical chemistry, and in the midst of the bacteriological revolution, Congress transformed the Bureau of Chemistry into a regulatory agency, fully expecting that science would be the arbiter of both health and commercial issues. Signed on 30 June 1906 by Theodore Roosevelt, along with the Meat Inspection Act, which put inspectors into all of the nation's slaughterhouses, the 1906 Pure Food and Drugs Act is still considered by historians to be one of the most significant pieces of Progressive-era legislation. In 1927, the regulatory component of the Bureau of Chemistry became the Food, Drug, and Insecticide Administration, renamed the Food and Drug Administration in 1930.

Within the decade following passage of the 1906 Pure Food and Drugs Act, the consumer marketplace was transformed. Wiley felt strongly about certain issues, and highly contentious and even more highly publicized legal cases were fought over them. But it was the routine enforcement of the simplest adulteration and misbranding portions of the law that transformed the commercial landscape of the country. New federal food and drug inspectors worked with businesses, factories, and trade organizations to update equipment, institute basic sanitary procedures, and apply insights gained from the burgeoning science of bacteriology to safeguarding the nation's food and drug supply. Added to initial concerns about food additives, and in the wake of Pasteur's discovery of the microorganisms responsible for food fermentation as well as some diseases, came increasing concerns about microorganisms in food as a cause of disease. Under Wiley's leadership, the Bureau of Chemistry continued to identify products and pathogens that moved food safety from abstract speculation to concrete action. Wiley began to hire expert microbiologists who, in turn, helped transform the canning and egg industries and shape the new refrigeration industry, helping to insure safer food for all Americans. By the time Wiley left office, in 1912, many known commonplace dangers had been eliminated from interstate commerce, though threats such as botulism, mycotoxins, and e-coli were soon to be discovered. Improvements in the drug trade as well paved the way for extraordinary future advances in therapeutics.

By the 1930s, the 1906 act had become seriously outdated. A new multimillion dollar cosmetic industry, new food products and pesticides, new drugs and new classes of drugs including barbiturates and sulfa drugs, and changes in the field of advertising all made deficiencies in the Wiley Act increasingly apparent. With the active support of consumer advocates such as Consumer's Research and Consumer's Union, so-called "guinea-pig" muckraking journalists, women's organizations, and Eleanor Roosevelt herself, the old law was replaced during the New Deal with the 1938 Food, Drug, and Cosmetic Act. Propelling the new legislation through Congress and onto President Franklin Roosevelt's desk was a 1937 drug disaster. "Elixir sulfanilamide," which contained a poisonous solvent, diethylene glycol, killed over 100 people before the entire field force of the FDA could be dispatched to retrieve every ounce of the product. This episode generated support for an important new provision in the 1938 act requiring companies to perform pre-market safety testing of all new drugs and gain FDA approval before marketing them.

In 1940, the Food and Drug Administration left the Department of Agriculture to become part of a new Federal Security Agency; and in 1953, it was transferred to the Department of Health, Education and Welfare (DHEW). In 1968, FDA became a component of the Public Health Service (PHS). In 1980, education was removed from the DHEW's responsibilities, and it was renamed the Department of Health and Human Services (DHHS). During the 1960s, 1970s, and 1980s, the Drug Enforcement Administration, the Consumer Product Safety Commission, and parts of the Environmental Protection Agency and Federal Trade Commission were all created to extend consumer protection procedures pioneered by the Food and Drug Administration to stop illegal drug sales, recall dangerous consumer durable goods, set tolerances for agricultural chemicals, and control drug advertising.

Significant pieces of legislation broadening and extending FDA's premarket activities were enacted between 1958 and 1976. In the Food Additives Amendment of 1958 and the Color Additives Amendment of 1960, a pre-market approval system was established for food and color additives, requiring that such substances be shown to be safe, suitable, and non-carcinogenic. In 1961, a worldwide scandal erupted over the teratogenic drug thalidomide, responsible for thousands of birth defects in Europe and a few in the United States, where the drug was never approved for sale. In 1962, Congress significantly strengthened FDA's authority over drugs, charging it with assessing both the safety and efficacy of new drugs prior to approval. In 1976, medical devices were subjected to pre-market regulatory assessment, and a system devised to assess such devices in accordance with their perceived risks—three separate risk categories representing high, moderate, and low risks were established. In 1971, the PHS Bureau of Radiological Health was transferred to FDA, bringing with it responsibility for ensuring the safety of radiation-emitting consumer products such as televisions and microwave ovens. In 1972, regulation of biologic products, including serums, vaccines, and blood products, was transferred from the National Institutes of Health (NIH) to FDA.

FDA currently regulates approximately $1 trillion worth of products each year (including both domestic and imported goods), representing about 25 cents of every dollar spent by consumers each year. The agency's fiscal year 2002 budget is $1.553 billion, including $184 million in industry-assessed user fees. The FDA employs about 10,000 personnel in the Washington area and in 167 field offices throughout the United States and Puerto Rico. Included in the fiscal year 2002 budget is an increase of $151.1 million and 832 full-time employees for activities related to bioterrorism and emergency preparedness following the tragic events on 11 September 2001.

BIBLIOGRAPHY

Goodwin, Lorine Swainston. The Pure Food, Drink, and Drug Crusaders, 1879–1914. Jefferson N.C.: McFarland, 1999.

Junod, Suzanne White. "Food Standards in the United States: The Case of the Peanut Butter and Jelly Sandwich." In Food, Science, Policy and Regulation in the Twentieth Century. Edited by David F. Smith and Jim Phillips. London: Rout-ledge, 2000.

Maeder, Thomas. Adverse Reactions. New York: Morrow, 1994.

Marcus, Alan I. Cancer from Beef: DES, Federal Food Regulation, and Consumer Confidence. Baltimore: Johns Hopkins University Press, 1994.

Marks, Harry M. The Progress of Experiment: Science and Therapeutic Reform in the United States, 1900–1990. Cambridge: Cambridge University Press, 1997.

Okun, Mitchell. Fair Play in the Marketplace: The First Battle for Pure Food and Drugs. Dekalb, Ill.: Northern Illinois University Press, 1986.

Swann, John P. "Sure Cure: Public Policy on Drug Efficacy before 1962." In The Inside Story of Medicines: A Symposium, Madison, Wis.: American Institute of the History of Pharmacy, 1997.

White, Suzanne. "The Chemogastric Revolution and the Regulation of Food Chemicals." In Chemical Sciences in the Modern World. Edited by Seymour H. Mauskopf. Philadelphia: University of Pennsylvania Press, 1993.

Young, James Harvey. Pure Food: Securing the Federal Food and Drugs Act of 1906. Princeton, N.J.: Princeton University Press, 1989.

Suzanne WhiteJunod

See alsoJungle, The ; Pure Food and Drug Movement .

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Food and Drug Administration

FOOD AND DRUG ADMINISTRATION

The U.S. Food and Drug Administration (FDA), an agency of the U.S. Department of Health and Human Services, advances the nation's welfare by protecting consumers against health hazards that usually are beyond an individual's control. The agency's origins go back to the 1906 publication of Upton Sinclair's best-selling novel The Jungle, which described in graphic detail the filth and unsanitary practices then prevailing at the Chicago stock-yards. The public's outraged response prompted the Congress to pass the Food and Drugs Act of 1906, the first federal law aimed at preventing interstate commerce in misbranded and adulterated foods, beverages, and drugs. Enforcement of this rather limited act was entrusted to the U.S. Department of Agriculture's (USDA) Bureau of Chemistry, which in 1930 became the FDA.

The weakness of the law was fully revealed in 1937, when a widely marketed toxic elixir of sulfanilamide killed 107 people, mostly children. Following another storm of public indignation, Congress passed the Federal Food, Drug, and Cosmetic Act of 1938 (FFDCA), which completely overhauled and greatly broadened the FDA's powers and responsibilities. The law's key provisions required new drugs to be shown to be safe before they could be marketed; defined adulterated and misbranded food; authorized standards of identity, quality, and fill-of-container for foods; and authorized the FDA to inspect facilities producing regulated products.

Even these sweeping provisions have failed at times to protect the public against new hazards, and Congress has strengthened the FFDCA by passing more than 200 amendments. Landmark additions to the act include the Kefauver-Harris Drug Amendments of 1962, which required manufacturers to prove that their medicines are effective as well as safe; the Medical Device Amendments of 1976, which extended similar requirements to medical equipment; and the FDA Modernization Act of 1997, which directed the agency to carry out its mission in close cooperation with other public health groups, both in the United States and abroad.

At the end of the twentieth century, the FDA's mandated responsibilities included ensuring the safety of the entire food supply (except for meat and poultry, which remained under the USDA's purview); making certain that all drugs, medical devices, vaccines, blood products, tissues for transplantation, and animal drugs and feeds are safe and effective when properly used; and assuring that cosmetics and devices that emit radiation do no harm. All of these products, which are manufactured, transported, warehoused, and retailed by more than 110,000 establishments, are worth about $1 trillion a year, or a fifth of all consumer expenditures. In 2000, the per capita cost of this protection was less than two cents a day.

The head of the FDA is the Commissioner of Food and Drugs, a presidential appointee who is confirmed by the Senate. About two-thirds of the FDA's 9,000 employees work in five product-focused centers. The FDA's Center for Food Safety and Applied Nutrition primarily ensures that food products do not contain hazardous pesticides or other contaminants, and that they are truthfully labeled. This center also works with producers to ascertain that genetically modified foods do not present a health risk. The other four centers Evaluation and Research; Biologics Evaluation and Research; Devices and Radiological Health; and Veterinary Medicinedevelop standards for product safety and effectiveness and make sure that the standards are met by reviewing the manufacturers' applications before allowing new health care products on the market.

In general, the application data must be derived from rigorously designed and controlled clinical trials that, for most drugs, include toxicity tests in animals, safety tests in healthy subjects, and studies of safety and effectiveness in large groups of patients. For the most complex drugs and devices, the FDA also relies on the recommendations of advisory panels of outside specialists who evaluate the products in public meetings. To be approved, each product's benefits must outweigh the risks of its use. Continued compliance of marketed products with FDA standards is ensured by the agency's inspectors, investigators, and food safety officers that are located in 174 communities from coast to coast and in Puerto Rico and by twelve national FDA laboratories.

The fast-growing U.S. dependence on imported food and health care products; the global spread of AIDS (acquired immunodeficiency syndrome); mushrooming international tourism; and the development of new, highly sophisticated food, pharmaceutical, and device technologies in the late 1900s greatly increased the complexity of the FDA's mission. To meet the new challenges, the FDA has developed strong scientific ties with academia and the private sector and worked closely with foreign governments to enhance public health standards around the globe. By the onset of the twenty-first century, the FDA's role had expanded from protecting hygiene at Chicago stockyards to promoting cooperation with product regulators all over the world.

Lawrence Bachorik

(see also: Benefits, Ethics, and Risks; Foods and Diets; Pharmaceutical Industry; United States Public Health Service [USPHS] )

Bibliography

Food and Drug Administration. From Test Tube to Patient. Available at http://www.fda.gov/cder/about/default.htm.

Milestones in U.S. Food and Drug Law History. Available at http://www.fda.gov/opacom/backgrounders/miles.html.

Food and Drug Law Institute (2000). Compilation of Food and Drug Laws. Washington, DC: Author.

Jackson, C. O. (1970). Food and Drug Legislation in the New Deal. Princeton, NJ: Princeton University Press.

Young, J. H. (1989). Pure Food. Princeton, NJ: Princeton University Press.

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Food and Drug Administration

FOOD AND DRUG ADMINISTRATION

The Food and Drug Act of 1906, which prohibited the interstate trade of misbranded or tainted food, drinks, and drugs, was passed by Congress on the same day as the Meat Inspection Act. At this time there was no Federal Drug Administration, but there was a Bureau of Chemistry. In 1927 a separate enforcement agency known as the Food, Drug and Insecticide Administration was create and in 1930 it was renamed the Food and Drug Administration (FDA). In 1938 after five years of battle with Congress, the Federal Food, Drug, and Cosmetic Act was passed. According to the FDA's Web site, it contained the following new provisions:

  • Extending control to cosmetics and therapeutic devices
  • Requiring new drugs to be shown safe before marketingstarting a new system of drug regulation
  • Eliminating the Sherley Amendment requirement to prove intent to defraud in drug misbranding cases
  • Providing that safe tolerance is set for unavoidable poisonous substances
  • Authorizing standards of identity, quality, and fill-of-container for foods
  • Authorizing factory inspections
  • Adding the court injunctions to the previous penalties of seizures and prosecutions

Later the FDA's jurisdiction was expanded to include microwaves and any radiation-emitting consumer products, as well as veterinary drugs and pet food. The agency monitors the manufacture, transportation, and sale of food and drugs. To ensure its efficiency, the FDA operates in 157 cities and employs approximately 9000 people. Among its employees are chemists, microbiologists, and investigators who visit 15,000 locations each year.

FDA inspectors visit businesses that are regulated by the FDA. If a problem exists, the FDA allows the company to voluntarily correct the problem or recall the faulty product. If the company refuses to cooperate, the FDA can go to court to force cooperation. Court action can include criminal prosecution if necessary.

In the area of drug control, the FDA does not conduct its own experiments but closely examines the results of the company's research. FDA inspectors conduct three types of inspections: study oriented, investigation oriented, and bioequivalence inspections. Study-oriented inspections are needed in case of new drug or new-product applications for approval. An investigator-oriented inspection may be ordered if other investigators looking at the same study think the findings are inconsistent. If one study is the sole basis for a marketer request, a bioequivalence study is conducted.

Once a drug or device is approved, the agency's responsibility does not end. The FDA monitors any complaints and looks for any adverse reactions associated with the product. As a result, approximately 3,000 products are recalled each year.

In addition to ensuring the quality of the product itself, the FDA has had a major influence on businesses


and the way goods are packaged. For example, medicines and products dangerous to children are now packaged in childproof bottles, and labels on containers of food products must list the nutritional contents and their amounts.

Any company that produces a product that is under the jurisdiction of the FDA has felt the pressure of its regulations, and complaints have been made about the slowness of the FDA's procedures. However, no country's citizens enjoy more protection regarding the products they use than U.S. citizens.

More information is available from the Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, or http://www.fda.gov.

see also Consumer Advocacy and Protection

bibliography

Food and Drug Administration. Frequently Asked Questions. Retrieved October 18, 2005, from http://www.fda.gov/opacom/faqs/faqs.html.

Food and Drug Administration. Information Sheets, "Guidance for Institutional Review Boards and Clinical Investigators". Retrieved October 18, 2005, from http://www.fda.gov/oc/oha/IRB/toc.html.

Food and Drug Administration. Milestones in United States Food and Drug Law History. Retrieved October 18, 2005, from www.fda.gov/opacom/backgrounders/miles.html.

Food and Drug Administration. Small Business Guide to FDA. Retrieved October 18, 2005, from http://www.fda.gov/ora/fed_state/Small_Business/sb_guide/default.htm..

Food and Drug Administration. Warning Letters. Retrieved October 18, 2005, from http://www.fda.gov/foi/warning.htm..

Val Hinton

Mary Jean Lush

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FDA (United States Food and Drug Administration)

FDA (United States Food and Drug Administration)

The Food and Drug Administration (FDA), a Department of Health and Human Services agency, regulates the development, sale, and distribution of food products, prescription and over-the-counter drugs, cosmetics, and medical equipment. The FDA's reach is so extensive that one-fifth of all consumer dollars spent in the U.S. purchase a product regulated by the FDA. The goal of the FDA is to protect consumers by ensuring the safety of food and drug products sold in the U.S.

The FDA traces its history to 1862, when President Abraham Lincoln created a chemistry division under the Department of Agriculture. Congress created the modern FDA in 1906 with the passage of the Food and Drugs Act. The 1906 law gave limited power to the FDA to monitor the safety of food and drug products. In 1938, Congress expanded the power of the FDA by passing the Food, Drug, and Cosmetic Act. This act granted the FDA the power to test drugs and determine their safety and efficacy before allowing companies to sell the new drugs. The act also granted the FDA authority to regulate cosmetics.

While the FDA's primary task is to ensure food and drug safety, in recent years the agency has taken on an increased role in the fight against bioterrorism. The FDA is leading efforts to develop and produce vaccines and treatments plans to prevent or stop the spread of a bioterror attack. In this quest, the FDA must quickly test vaccines, so private companies can produce and stockpile vaccines.

The variety of possible pathogens (disease-causing microorganisms) that might be used in bioterrorism has tested the limits of the FDA. The administration must simultaneously assess the effectiveness of vaccines and treatments for anthrax, smallpox, botulism, plague, hemorrhagic fevers, and other potential bioweapons. Additionally, the FDA, in conjunction with the Centers for Disease Control, must take into account that terrorists might genetically alter existing pathogens to reduce the efficacy of current vaccines and treatments. The FDA plans to thwart potential terrorist attacks by expediting its approval process for new vaccines and drugs that could reduce the severity of a bioterror attack.

FURTHER READING:

ELECTRONIC:

Department of Health and Human Services. "United States Food and Drug Administration." <http://www.fda.gov> (May 2003).

SEE ALSO

Bioterrorism, Protective Measures
Food Supply, Counter-Terrorism
Salmonella and Salmonella Food Poisoning
Vaccination

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FDA (United States Food and Drug Administration)

FDA (United States Food and Drug Administration)

Forensic science can involve the examination of foodstuffs and other items used by consumers. If contaminated or faulty, these items can cause illness or death.

Various federal government agencies participate in the regulation of consumer goods, which can involve the forensic determination of the circumstances surrounding accidents, illness outbreaks, or deaths. Principal among these is the Food and Drug Administration (FDA).

The FDA is an agency of the Department of Health and Human Services. Its mandate is the regulation of the development, sale, and distribution of food products, prescription and over-the-counter drugs, cosmetics, and medical equipment. The FDA's reach is extensive; one-fifth of all consumer dollars spent in the U.S. purchase a product regulated by the FDA. The goal of the FDA is to protect consumers by ensuring the safety of food and drug products sold in the U.S.

The FDA traces its history to 1862, when President Abraham Lincoln created a chemistry division under the Department of Agriculture. Congress created the modern FDA in 1906 with the passage of the Food and Drugs Act. The 1906 law gave limited power to the FDA to monitor the safety of food and drug products. In 1938, Congress expanded the power of the FDA by passing the Food, Drug, and Cosmetic Act. This act granted the FDA the power to test drugs and determine their safety and efficacy before allowing companies to sell the new drugs. The act also granted the FDA authority to regulate cosmetics.

While the FDA's primary task is to ensure food and drug safety, in recent years the agency has taken on an increased role in addressing the deliberate contamination of foods. The FDA is leading efforts to develop and produce vaccines and, in conjunction with agencies such as the Centers for Disease Control and Prevention , takes a role in the forensic investigation of food-borne outbreaks, especially if the outbreak can be traced to a breach in the food chain from the field to the consumer.

see also Escherichia coli ; Food poisoning; Pathogens; Toxins.

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Food and Drug Administration

Food and Drug Administration (FDA), agency of the Public Health Service division of the U.S. Department of Health and Human Services. It is charged with protecting public health by ensuring that foods are safe and pure, cosmetics and other chemical substances harmless, and products safe, effective, and honestly labeled. The Food, Drug, and Cosmetic Act of 1938 and various bills since have strengthened government control by requiring prior-evidence-of-safety tests and procedures for new drugs, pesticides, and additives and colorings in foods and cosmetics. The FDA was first established in 1931; in 1940 it was transferred from the Dept. of Agriculture to the Federal Security Agency and in 1953 to the Dept. of Health, Education and Welfare, which was redesignated as Health and Human Services in 1979. The FDA consists of the centers for Drug Evaluation and Research, Biologics Evaluation and Research, Food Safety and Applied Nutrition, Veterinary Medicine, Devices and Radiological Health, and Toxicological Research. In the early 1990s, in response to criticism that its time-consuming approval processes penalized people with AIDS, it extended the classification system it uses to prioritize drugs in order to give AIDS drugs the highest priority; it also subsequently sped up the approval process for cancer drugs. Congressional legislation in 1997 mandated an overhaul of the FDA in order to speed review of new drugs and medical devices.

See P. J. Hilt, Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation (2003) and D. Carpenter, Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA (2010).

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Food and Drug Administration

Food and Drug Administration (FDA) US federal agency within the Department of Health and Human Services, established in 1979. Its purpose is to protect against impure and unsafe foods, drugs and cosmetics, and other potential hazards. The FDA divides into several bureaux.

http://www.fda.gov

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FDA

FDA Food and Drug Administration; US government regulatory agency; web site www.fda.gov; web site for FDA consumer magazine www.fda.gov/fdac.

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