the bill, Grove L. Johnson, switched his aye vote to nay in order to move for reconsideration of the defeated bill. After a heated debate at the very end of the legisla tive session, the Woman Lawyer’s Bill passed the assembly. The bill nearly died until Foltz managed a last-minute audience with Governor William Irwin. In the waning hours of the session, on the last possible day, March 29, 1878, the governor signed the bill. Foltz and Gordon divided their responsibil- ities the summer of 1878. Foltz studied and was the first woman to take advantage of their recent legislative success, taking the BAR EXAMINATION . Gordon, although she was not a delegate, attended the first California constitu- tional convention as a member of the press, and successfully lobbied for the inclusion of two clauses that she and Foltz had a hand in drafting. The first clause prohibited restrictions to any business, vocation, or profession based on sex; the second prohibited SEX DISCRIMINATION in college faculty hiring. Foltz passed the bar examination and became California’s first female lawyer on September 5, 1878. In January 1879, Foltz and Gordon registered for classes at Hastings, California’s first law school. However, after only a few days of classes, Foltz received a letter from the Hastings Law School Board , informing her that the directors had resolved not to admit women. Foltz and Gordon filed suit to compel the college, as a state institution, to admit women. The district court judge, who reportedly did not believe in women lawyers, nevertheless found these women lawyers to be correct in the law, and ordered Hastings to admit them. Hastings appealed, and the case went to the California Supreme Court (Foltz v. Hoge, 54 Cal. 28 [1879 ]). Although Foltz and Gordon were victorious again, the time for Foltz to attend law school had passed. She went to Sacramento to serve as clerk, or counsel, to the judiciary committee of the state assembly. Foltz neverthe- less considered the Hastings victory to be her finest moment. Foltz had a long and successful career as an attorney, first in San Francisco and then in Los Angeles. She practiced probate, criminal, family, and corporate law. Some of her very first cases, in 1878, heard in justice court, involved reclaiming the property of young women put in vulnerable circumstances by desertion, ill- ness, or an ex-employer. Throughout her career, in addition to conducting a thriving practice, she worked for suffrage and women’s rights. She actively encouraged the participation of women in the legal profession. In 1893, she organized the Portia Law Club in San Francisco. She taught women the law at her offices in San Francisco and in Los Angeles, where she relocated in 1906. In 1918, she helped found the Women Lawyers’ Club in Los Angeles. She was responsible for California laws allowing qualified women to act as administrators, executors, and notaries public. Foltz was a primary force behind improving the criminal defense system. In 1893 she represented the California bar at the National Congress of Jurisprudence and Law Reform, held in conjunction with the Chicago World’s Fair. It was there that she first introduced the Foltz Public Defender Bill. This proposal was subsequently adopted, owing in large part to her lobbying, in over thirty states. The Foltz Public Defender Bill proposed a defender system in which salaried lawyers would devote all or a substantial part of their time to the specialized practice of representing indigent defendants, as opposed to the existing system, in which the court appointed lawyers on an ad hoc basis from the bar at large. The model bill proposed that public defenders meet certain qualifications, receive a salary, have clearly defined job responsibilities, and serve for a term of office. A public defender would be a county officer who would defend, without expense to them, all person s who were not financially able to employ counsel and who were charged with the commission of any contempt, MISDEMEANOR, felony, or other offense. Nearly two decades passed befo re the first public defender office was actually established in Los Angeles County in 1914, where Foltz was then living. In fact, she had already served as the first woman deputy district attorney, in 1911. It was 1921 before California passed a statewide public defender bill. Foltz was also an active writer and publish- er. She founded the weekly newspaper The San Diego Bee. She also published a feminist weekly, The Mecca, during a brief stay in Colorado, and a magazine, The New American Woman. She also contributed articles to other papers and magazines throughout her life. THEY CALLED ME THE LADY LAWYER A DAINTY SOBRIQUET THAT ENABLED ME TO MAINTAIN A DAINTY MANNER AS I BROWBEAT MY WAY THROUGH THE MARSHES OF IGNORANCE AND PREJUDICE . —CLARA FOLTZ GALE ENCYCLOPEDIA OF AMERICAN LAW, 3RD E DITION FOLTZ, CLARA SHORTRIDGE 479 Foltz died in Los Angeles on September 4, 1934. The pallbearers for her funeral included the governor and several prominent federal and state judges. FURTHER READINGS Akers, Virginia Elwood. 1984. “Clara Shortridge Foltz, California’s First Woman Lawyer.” Pacific Historian 28. Babcock, Barbara Allen. 1991. “Clara Shortridge Foltz: Constitution Maker.” Indiana Law Journal 66. ———. 1994. “Clara Shortridge Foltz: ‘First Woman’.” Valparaiso Univ. Law Review 28. ———. 1993. “A Place in the Palladium: Women’s Rights and Jury Service.” Cincinnati Law Review 61. Foltz, Clara Shortridge. 1897. “Public Defenders.” American Law Review 31. Polos, Nicolas C. 1980. “San Diego’s ‘Portia of the Pacific’: California’sFirstWomanLawyer.” The J ournal of San Diego History 26, no. 3. Available onlinei at https://www. sandiegohistory.org/journal/80summer/portia.htm; web - site home page: https://www.sandiegohistory.org (accessed July 24, 2 009 ). Schwartz, Mortimer D., Susan L. Brandt, and Patience Milrod. 1976. “Clara Shortridge Foltz: Pioneer in the Law.” Hastings Law Journal 27. Available online at http:// www.countyofsb.org/defender/Docs/HastingsFoltz.html; website home page: http://www.countyofsb.org (accessed July 24, 2009). 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 more than 1,000 investigators and inspectors who visit more than 15,000 food- processing, drug-manufacturing, and other facili- ties each year. If it finds violations of law, the FDA first encourages an offending company to volun- tarily correct the problem or to recall a faulty product from the market. If the firm does not voluntarily comply with the law, theFDA 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 more than 2,000 scientists—including 900 chemists and 300 microbiologists—w ho provide the SCIENTIFIC EVIDENCE to back up its regulatory and inspec- tion 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 sele cted 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 proh ibited 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 nam e 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. GALE ENCYCLOPEDIA OF AMERICAN LAW, 3RD E DITION 480 FOOD AND DRUG ADMINISTRATION This tragedy prompted the passage of the next major reform of food and drug law, the Federal Food, Drug, and Cosmetic Act of 1938 (21 U.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 safe ty, 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 laborat ory animals. In 1962 the Kefauver-Harris Drug Amend- ments (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 thou- sands 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 implica- tions 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 implemen- ted 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 ENGINEER- ING methods, ionizing radiation (irradiation), and sewage sludge for fertilization. In addition, all agricultural products that are labeled organic must originate from farms or handling opera- tions 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 hu- man use. It also monitors drug advertising for accuracy, ensures the safety and rights of patients in drug studies, and distributes infor- mation 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 coordi- nates 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 devel- ops manufacturing standards for such devices. The Center for Veterinary Medicine evalu- ates the safety of drugs and devices used on animals. The National Center for Toxicological Research assesses the biological effects of toxic chemical substances. 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. 2002. “Preparing for and Surviving FDA Inspections.” Update 1 (January/February). Washington, D.C.: The Food and Drug Law Institute. Burkholz, Herbert. 1995. The FDA Follies. New York: Basic. “Center for Drug Evaluation and Research.” 2009. U.S. Food and Drug Administration. Available online at http:// www.fda.gov/AboutFDA/CentersOffices/CDER/default. htm; website home page: http://www.fda.gov (accessed July 24, 2009). GALE ENCYCLOPEDIA OF AMERICAN LAW, 3RD E DITION FOOD AND DRUG ADMINISTRATION 481 “FDA Mission Statement.” 2009. U.S. Food and Drug Administration. Available online at http://www.fda.govt (accessed July 24, 2009). Harmon, Daniel E., and Arthur Meier Schlesigner. 2002. The Food and Drug Administration. New York: Chelsea House. Parver, Deborah G. 1999. “Expediting the Drug Approval Process: An Analysis of the FDA Modernization Act of 1997.” Administrative Law Review 51 (fall). Available online at http://www.wcl.american.edu/journal/alr/51/ 51-4parver.pdf?rd=; website home page: http://www. wcl.american.edu (accessed July 24, 2009). “Reinventing Drug and Medical Device Regulations.” National Performance Review (April 1995). Washington, D.C.: U.S. Government Printing Office. Available online at http://govinfo.library.unt.edu/npr/library/ reinvent-fda.htm; website home page: http://govinfo. library.unt.edu (accessed July 24, 2009). How the FDA Approves New Drugs T he 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 investiga- tional 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 molecu- lar 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. Plus, statisti- cians evaluate the design and results of controlled studies. Comp lete eval uation is an expen- sive and time consuming process, particularly for t he company developing the drug, called a drug sponsor. A sponsor spends an average of $802 million for each new drug brought to market. Typically, the process takes up to eight years and may be divided into roughly three stages: preclinical trials, involving animal and other laboratory tests (lasting one and a half years on aver age); clinical t rials, involving tests on humans (five year s); 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 guide- lines 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 com- posed of scientists, ethicists, and non- scientists, 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 ani- mal testing of the drug in order to better understand the drug’s long-term effects. Clinical Trials Clinical trials are sci- entifically 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 to several hundredtoseveral 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 additional evidence regarding its safety and effectiveness. GALE ENCYCLOPEDIA OF AMERICAN LAW, 3RD E DITION 482 FOOD AND DRUG ADMINISTRATION “Reinventing the Regulation of Drugs Made from Biotech- nology.” 1995. Washington, D.C.: U.S. Government Printing Office. Available online at http://govinfo. library.unt.edu/npr/library/951109.html; website home page: http://govinfo.library.unt.edu (accessed July 24, 2009). “Significant Dates in U.S. Food and Drug Law History.” 2009. U.S. Food and Drug Administration. Available online at http://www.fda.gov/AboutFDA/WhatWeDo/ History/Milestones/ucm128305.htm; web site home page: http://www.fda.gov (accessed July 24, 2009). U.S. Food and Drug Administration Web site. Available online at http://www.fda.gov (accessed July 24, 2009). U.S. Government Manual Web site. Available online at http://www.gpoaccess.gov/gmanual/index (accessed July 21, 2009). Of 100 drugs submitted for testing in humans, an average of 70 will pass phase 1. Of these 70, on average, only 33 will remain after phase 2 testing, and 25 to 30 after phase 3. Finally, an average of only 20 will actually receive FDA approval. Once the drug sponsor has complet- ed clinical trials, it submits a new drug application (NDA) to the FDA, requesting approval to market the drug. This application consists of docu- mentation detailing the chemical compo- sition 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 deter- mine whether the benefits of the new drug outweigh the risks. To reach this determi- nation, the FDA examines the documen- tation provided by the sponsor and looks at samples of the drug. If inadequacies are discovered in the NDA, the FDA may require addi- tional 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 con- sulted. 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 longstand- ingpoliciesallowingwhatitcallsthe 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 approvalofnewdrugs.Particularly withthe emergence of AIDS during the 1980s, the public outcry for fast delivery of innovative new drugs strengthened. As science pro- duces 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 per- mit certain drugs to be designated as investigational new drugs for treatment, or INDs. A treatment IND may be administered to patients even while it is still undergoing clinical trials. This pro- gram allows patients with no other alter- natives to undergo a treatment that may benefit their health. By 1999, 39 agents had been designated treatment INDs. Between 1997 and 2005, an average of 659 patients received INDs. A 2009 FDA rule was designed to expand patient access to INDS. The FDA estimates a 50 percent increase in patients using these drugs. By 1995, more than 75,000 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 treat- ments. 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 priori- ty 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 promis- ing 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 manu- facturers are used by the agency to hire hundreds of additional review staff and buy improved equipment, including compu- ters that make review more efficient. Efforts that began in the mid-1990s to streamline the drug approval process have proved successful. In 1994 a new drug was 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. By 2009 the FDA approved priority drugs within six months and standard drugs within ten months. GALE ENCYCLOPEDIA OF AMERICAN LAW, 3RD E DITION FOOD AND DRUG ADMINISTRATION 483 FOOTNOTE 4 Footnote 4 is a footnote to United States v. Carolene Products Co., 304 U.S. 144, 58 S. Ct. 778, 82 L. Ed. 1234 (1938), in which the U.S. Supreme Court upheld the constitutionality of the Filled Milk Act, 42 Stat. 1486, which Congress passed in 1923 to regula te certain dairy products. Written by Justice HARLAN F. STONE, footnote 4 symbolizes the end of one era of constitutional jurisprudence and the dawning of another. In upholding the constitutionality of the Filled Milk Act, the Supreme Court drew a distinction between legislation that regulates ordinary economic activities and legislation that curtails important personal liberties. The con- stitutional authority of state and federal legis- latures over economic matters is plenary, the Court said, and laws passed to regulate such matters are entitled to a presumption of constitutionality when reviewed by the judicial branch of government. Courts must pay great deferen ce to legisla- tion that is principally aimed at economic affairs, the Court continued, and judges should refrain from questioning the wisdom or policy judgments underlying such legislation. Al- though some commercial laws may seem undesirable or unnecessary to a particular judge, the Court cautione d, the judicial branch may not overturn them unless they fail to serve a rational or legitimate purpose. This deferential posture toward the legisla- tive branch represents the crux of judicial self- restraint, a judicial philosophy that advocates a narrow role for courts in U.S. constitutional democracy. Because state and federal legislatures are constitutionally authorized to make the law, proponents of judicial self-restraint argue, courts must limit their role to interpreting and applying AZT: An Agent of Change for the FDA A B zidothymidine (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 flexib le drug approval. The pharmaceutical company Burroughs We ll- come first presented AZT as a new drug to the FDA in June 1985. Public fear of AIDS had increa sed dramatically during the previous few years, as had protests by AIDS activists who complained of slow FDA movement with regard to promising new treatments. Keenl y aware of the need for swift decision making in the f ace of the deadly AIDS disease, the FDA approved phase 1 clinical trials of the drug within one week of the in itial 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 place bo was switched to AZT, and phase 3 testing, traditi onally the most important step in clinical trials, was deemed unnecessary. In September 1986 the FDA authorized the treatment of patients who wanted a ccess to AZT, even before it had given approval to the d rug. By the time approval fo r general public use came in March 1987, some 4,000 patients had already been t reated with AZT, and thus the drug was alread y potentially extending the lives of h undreds 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 t o the pharmaceu- tical industry, which has since used t he accelerated process to bring new, more effective AIDS drugs to market much more rapidly and at lower cost. CROSS REFERENCE Acquired Immune Deficiency Syndrome. GALE ENCYCLOPEDIA OF AMERICAN LAW, 3RD E DITION 484 FOOTNOTE 4 the law, except in the rare instance where a piece of legislation clearly and unequivocally violates a constitutional provision, in which case they may strike it down. In footnote 4 the Supreme Court indicated that this presump tion of constitutionality might not apply to certain categories of noneconomic legislation. Legislation that restricts political processes, discriminates against minorities, or contravenes a specifically enumerated constitu- tional liberty, the Court said, may be subject to “more searching judicial scrutiny.” Legislation that limits the right to assemble peaceably, the freedom to associate, or the liberty to express dissenting viewpoints, the Court suggested, tends to obstruct ordinary political channels that average citizens traditionally rely on to participate in the democratic process. By the same token, the Court suggested that legislation discriminating against racial, religious, and ethnic minorities tends to marginalize groups that are already politically weak and vulnerable. The Court also reasoned that legislation contravening a specifically enumerated consti- tutional right should be given less deference by the judiciary than legislation that purportedly contravenes an unenumerated right. This pas- sage in the Court’s opinion alluded to its decision in an earlier case, LOCHNER V. NEW YORK, 198 U.S. 45, 25 S. Ct. 539, 49 L. Ed. 937 (1905), which has been maligned throughout the twentieth century. In Lochner the Supreme Court recognized an unenumerated freedom of contract that is loosely derived from the Fifth and Fourteenth Amend- ments to the U.S. Constitution. Based on this freedom, the Court struck down a New York law (N.Y. Laws 1897, chap. 415, art. 8, § 110) that regulated the number of hours employees could work each week in the baking industry. The Court said employers and employees enjoy an unwrit- ten constitutional right to determine their wages, hours, and working conditions without govern- ment interference. Over the next 32 years, state and federal courts relied on Lochner to invalidate scores of statutes that attempted to regulate employ- ment relations, business affairs, and various property interests. At the same time, the Supreme Court was upholding legislation that restricted specifically enumerated constitu- tional liberties, such as the FREEDOM OF SPEECH. For example, in SCHENCK V. UNITED STATES,249 U.S. 47, 39 S. Ct. 247, 6 3 L. Ed. 470 (1919), the Supreme Court upheld the ESPIONAGE ACT OF 1917, 40 Stat. 217, which prohibited the circulation of printed material that encouraged resistance to the military draft during WORLD WAR I . The reasoning of footnote 4 helped bring an end to the Lochner era and a reversal of the judicial standards of review for economic and noneconomic legislation. Before Carolene Pro- ducts, legislation that in any way touched upon an economic interest was subject to judicial scrutiny. During the same period, state and federal co urts gave leeway to legislation touch- ing upon nonecon omic freedoms, even the personal freedoms expressly contained in the BILL OF RIGHTS. Since Carolene Products, state and federal legislatures have be en given wide latitude to regulate the workplace, commercial interests, and other economic matters. Conversely, laws that have hindered access to political processes, discriminated against minorities, or impinged on fundamental freedoms contained in the Bill of Rights, as made applicable to the states through the FOURTEENTH AMENDMENT, have been deemed suspect, and subject to strict judicial scrutiny. Such laws are typically invalid ated by the judiciary unless the government can dem- onstrate that they serve a compelling interest. The legacy of footnote 4 can be observed in cases where the Supreme Court has expanded the class of minorities who are protected by heightened judicial scrutiny. In addition to the racial, ethnic, and religious minorities refer- enced in footnote 4, women, illegitimate children, and other “discrete and insular” minorities have received increased constitution- al protection by the Supreme Court since 1938. FURTHER READINGS Ackerman, Bruce A. 1985. “Beyond Carolene Products.” Harvard Law Review 98 (February). Linzer, Peter. 1995. “The Carolene Products Footnote and the Preferred Position of Individual Rights: Louis Lusky and John Hart Ely vs. Harlan Fiske Stone.” Constitu- tional Commentary 12 (summer). Perry, Matthew. 1996. “Justice Stone and Footnote 4.” George Mason Univ. Civil Rights Law Journal 6 (fall). Robinson, John H. 1998. “The Compromise of ‘38 and the Federal Courts Today.” Notre Dame Law Review 73 (May). CROSS REFERENCES Judicial Review; Strict Scrutiny. GALE ENCYCLOPEDIA OF AMERICAN LAW, 3RD E DITION FOOTNOTE 4 485 FORBEARANCE Refraining from doing something that one has a legal right to do. Giving of further time for repayment of an obligation or agreement; not to enforce claim at its due date. A delay in enforcing a legal right. Act by which creditor waits for payment of debt due by a debtor after it becomes due. Within usury law, the contractual obligation of a lender or creditor to refrain, during a given period of time, from requiring the borrower or debtor to repay the loan or debt then due and payable. FORCE Power, violence, compulsion, or constraint exerted upon or against a person or thing. Power dynamically considered, that is, in motion or in action; constraining power, compulsion; strength directed to an end. Commonly the word occurs in such connections as to show that unlawful or wrongful action is meant, e.g., forcible entry. Power statically considered, that is, at rest, or latent, but capable of being called into activity upon occasion for its exercise. Efficacy; legal validity. This is the meaning when we say that a statute or a contract is in force. Reasonable force is that degree of force that is appropriate and not inordinate in defending one’s person or property. A person who employs such force is justified in doing so and is neither criminally liable nor civilly liable in tort for the conduct. DEADLY FORCE is utilized when a person intends to cause death or serious bodily harm or when he or she recognizes personal involvement in the creation of a substantial risk that death or bodily harm will occur. FORCE MAJEURE [French, A superior or irresistib le power.]An event that is a result of the elements of nature, as opposed to one caused by human behavior. The term force majeure relates to the law of insurance and is frequently used in construction contracts to protec t the parties in the event that a segment of the contract cannot be per formed due to causes that are outside the control of the parties, such as natural disasters, that could not be evaded through the exercise of due care. FORCED SALE An involuntary transaction that occurs in the form and at the time specified by law for the purpose of applying the proceeds to satisfy debts, such as a mortgage or a tax lien, incurred by the owner of the property. A forced sale results from the execution of a judgment previously rendered by a court. FORCIBLE DETAINER A summary and expeditious statutory remedy used by a party entitled to actual possession of premises to secure its possession, where the occupant initially in lawful possession of it refuses to relinquish it when his or her right to possession ends. CROSS REFERENCE Forcible Entry and Detainer. FORCIBLE ENTRY AND DETAINER A summary proceeding to recover possession of land that is instituted by one who has been wrongfully ousted from, or deprived of, possession. Forcible entry and detainer, one aspect of which is known as UNLAWFUL DETAINER, alludes to two separate misdeeds and two divergent remedies of statutory origin. The forcible intrusion into another person’s peaceable possession constitutes one type of infraction. Even if it is unlawful, peaceable possession cannot be terminated by violence. In many jurisdictions, even the rightful owner is held liable for damages, which as provided by statutes are often multiple in nature, if he or she employs excessive force in ousting one in peaceful possession. In such instances, the offense involved is the force itself and not the actual dispossession. Hurricanes such as Hurricane Ike, which hit Texas in 2008, are examples of force majeure, as they are natural events that cannot be controlled. AP IMAGES GALE ENCYCLOPEDIA OF AMERICAN LAW, 3 RD E DITION 486 FORBEARANCE The second form of misdeed entails the initiation of LEGAL PROCEEDINGS by the rightful owner against a squatter without title or a tenant whodeclinestodepart.Forceinsuchinstances might be inconsequential, figurative, or nonexis- tent. Damages are avoidable, but the restoration of the lawful owner to possession of the property by eviction of the defendant is also within the purview of the remedy. This remedy, which awards both damages and possession, resembles ejectment, which also entails the RECOUPMENT of possession of property by the person entitled to it, but significant differences exist. In addition to historical dissimilarities, the summary nature of the forcible entry and detainer action is unlike the nature of an ejectment action. The trial and eviction can be accomplished within a few days after SERVICE OF PROCESS . Statutes frequently provide, however, that the decision in forcible entry or unlawful detainer is not binding as to title. If title is seriously disputed, a second and more compre- hensive suit in ejectment or TRESPASS is warranted. The forcible entry or unlawful detainer action is restricted to cases in which the plaintiff’sright to possession is unequivocal, because SUMMARY PROCEEDINGS would not be justified under any other circumstances. A minority of jurisdictions, however, limit the action to the eviction of those who have actually entered by force. A forcible entry suit, although burdensome in nature, functions not merely as a method of prompt relief but also affects a subsequent ejectment action. Because the BURDEN OF PROOF is imposed upon the PLAINTIFF who has been dispossessed in the ejectment suit, in regard to his or her own PARAMOUNT TITLE, the issue of possession determined in the forcible entry suit affects the ultimate burden of proof. It would be inequitable to permit this to be manipulated by those who forcibly enter, or perhaps even by holdover tenants. The forcible entry action, in dispossessing the occupant where his or her title is patently invalid, influences the ejectment action by its princ iple that the plaintiff never prevails on the basis of the possessor’s defective title, but must instead recover on the validity of his or her own title. The supposition that unlawful detainer involves possession and not title, whereas ejectment entails title, is somewhat inaccurate. Both ejectment and unlawful detainer actions are possessory in nature, and title is nearly always the basis of possessory rights. The differences in the two actions reside in the summary character of forcible entry, the restricted class of person against whom it can be instituted, and its lack of RES JUDICATA effect on title issues. These forcible entry and detainer, or summary eviction, statutes are primarily utilized by landlords attempting to regain possession of premises from recalcitrant tenants. The Supreme Court has upheld the validity of such statutes, regardless of the limited number of issues triable and the brief period between summons and trial. FURTHER READINGS “Forcible Entry and Detainer Overview.” The law office of D. L. Drain, Phoenix, AZ. Available online at http://www. dianedrain.com/RealProperty/ForcibleEntryDetainer/ FEDOverview.htm; website home page: http://www. dianedrain.com (accessed September 2, 2009). Kirschbaum, Stephen. 1996. “Prosecuting and Defending Forcible Entry and Detainer Actions.” The Journal of the Kansas Bar Association 65 (September). Sweetbaum, Alan, and E. James Wilder. 2000. “Forcible Entry and Detainer: A Primer.” Colorado Lawyer 29, no.10 (October). v FORD, GERALD RUDOLPH Without winning a single vote in a presidential election, Gerald Rudolph Ford became chief executive of the United States on August 9, 1974. Ford’s ascent to the White House began on October 12, 1973, when he was appointed by President RICHARD M. NIXON to succeed Vice President Spiro T. Agnew. Agnew left office on October 10, 1973, after PLEADING NOLO CONTENDERE (I will not contest it) to felonious TAX EVASION. Ford was a popular Republican congressman from Grand Rapids, Michigan, and the minority leader of the U.S. House of Representatives. The Nixon administration was on the brink of collapse as evidence of its criminal involvement in the WATERGATE break-in and cover-up mounted. The scandal ultimately destroyed the Nixon White House, forcing the president to resign from office to avoid impeachment. As a result, on August 9, 1974, Ford was sworn in as the nation’s38thpresident—and the first chief executive to be appointed to office. Named Leslie Lynch King Jr., when born July 14, 1913, in Omaha, Nebraska, Ford spent most of his childhood in Grand Rapids, where his mother settled in 1914 after divorcing his father. When Ford was three years old, his mother remarried, and the future president was adopted by and renamed after his stepfather, GERALD FORD Sr. Ford was a gifted athlete in high school and a college all-star on championship football GALE ENCYCLOPEDIA OF AMERICAN LAW, 3RD E DITION FORD, GERALD RUDOLPH 487 teams at the University of Michigan. After graduating from Michigan in 1935, he turned down offers to play professional football and instead coached football and boxing at Yale University for five years. Ford attended Yale Law School during this time, and gradua ted in 1941 in the top third of his class. After briefly practicing law in Grand Rapids, he enlisted in 1942 for a four-year tour with the Navy during WORLD WAR II. When the war ended, Ford returned to Grand Rapids and reestablished his law practice. He married Elizabeth (“Betty”) Bloomer Warren in 1948, and by 1957, the couple had four children. Ford was first elected to the U.S. House of Representatives from Michigan’s Fifth Congressional District in 1948. He served in the House for 25 years, consistently winning reelection in his home district by 60 percent or more of the vote. A domestic affairs moderate and a fiscal conservative, Ford was assigned to the Public Works Committee during his first term in Congress. In 1951 he managed to transfer committees, and subsequently served on the influential House Appropriations Com- mittee until 1965. Ford supported large defense budgets and a strong foreign policy, and opposed federal spending for several domestic social programs. After the 1963 ASSASSINATION of President JOHN F. KENNEDY, Ford was selected to serve on the WARREN COMMISSION, a bipartisan task force set up to investigate Kennedy’s MURDER. Later, Ford coauthored a book supporting the Warren Commission’s report that Kennedy was killed by lone gunman Lee Harvey Oswald. In 1963 Ford became chair of the House Republican Conference, and in 1964 he was named minority leader of the House of Representatives. At this stage in Ford’s political career, his greatest ambition was to become Speaker of the House. However, because Congress was controlled by a majority of Democrats, Ford’s goal was unattainable. Ford was a GOP loyalist who campaigned tirelessly for other Republican candidates. An accomplished fund-raiser, he was given credit for helping elect 47 new Republicans to the House of Representatives in 1966. In addition to campaigning and performing his congressional duties, Ford served as permanent chair of both the 1968 and 1972 Republican National Con- ventions. After the GOP’s victory in the 1968 Gerald R. Ford. LIBRARY OF CONGRESS. ▼▼ ▼▼ Gerald Rudolph Ford 1913–2006 1905 1950 1975 2000 1925 ❖ ◆ ◆ ◆ ◆ ◆ ◆ 2001 Co-chaired National Commission on Federal Election Reform with former president Jimmy Carter 1999 Awarded Congressional Gold Medal and Presidential Medal of Freedom ◆ ◆ 1980 Declined to run as Ronald Reagan’s running mate 1976 Ran for reelection with Bob Dole; lost to Jimmy Carter ◆ 1974 President Nixon resigned from office; Ford sworn in as president; pardoned Nixon 1972 Watergate break-in 1951–65 Served on the House Appropriations Committee 1942–46 Served in U.S. Navy 1963 Became chair of the Republican Conference 1964 Elected House minority leader by Republican peers 1941 Graduated from Yale Law School 1948 Began 25-year career in U.S. House of Representatives 1913 Born, Omaha, Neb. 1914–18 World War I 1939–45 World War II 1950–53 Korean War 1961–73 Vietnam War 2006 Died, Rancho Mirage, Calif. ◆❖ GALE ENCYCLOPEDIA OF AMERICAN LAW, 3RD E DITION 488 FORD, GERALD RUDOLPH . ten months. GALE ENCYCLOPEDIA OF AMERICAN LAW, 3RD E DITION FOOD AND DRUG ADMINISTRATION 48 3 FOOTNOTE 4 Footnote 4 is a footnote to United States v. Carolene Products Co., 3 04 U.S. 144 , 58 S. Ct. 778,. 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. REFERENCE Acquired Immune Deficiency Syndrome. GALE ENCYCLOPEDIA OF AMERICAN LAW, 3RD E DITION 48 4 FOOTNOTE 4 the law, except in the rare instance where a piece of legislation clearly and unequivocally