title: Food and Drug Administration

text: The Office of Criminal Investigations was established in 1991 to investigate criminal cases. To do so, OCI employs approximately 200 Special Agents nationwide who, unlike ORA Investigators, are armed, have badges, and do not focus on technical aspects of the regulated industries. Rather, OCI agents pursue and develop cases when individuals and companies commit criminal actions, such as fraudulent claims or knowingly and willfully shipping known adulterated goods in interstate commerce. In many cases, OCI pursues cases involving violations of Title 18 of the United States Code (e.g., conspiracy, false statements, wire fraud, mail fraud), in addition to prohibited acts as defined in Chapter III of the FD&C Act. OCI Special Agents often come from other criminal investigations backgrounds, and frequently work closely with the Federal Bureau of Investigation, Assistant Attorney General, and even Interpol. OCI receives cases from a variety of sources—including ORA, local agencies, and the FBI, and works with ORA Investigators to help develop the technical and science-based aspects of a case.


title: Food and Drug Administration

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


title: Food and Drug Administration

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


title: Food and Drug Administration

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


title: Food and Drug Administration

text: The programs for safety regulation vary widely by the type of product, its potential risks, and the regulatory powers granted to the agency. For example, the FDA regulates almost every facet of prescription drugs, including testing, manufacturing, labeling, advertising, marketing, efficacy, and safety—yet FDA regulation of cosmetics focuses primarily on labeling and safety. The FDA regulates most products with a set of published standards enforced by a modest number of facility inspections. Inspection observations are documented on Form 483.


title: Food and Drug Administration

text: In June 2018, the FDA released a statement regarding new guidelines to help food and drug manufacturers "implement protections against potential attacks on the U.S. food supply". One of the new guidelines includes the Intentional Adulteration (IA) rule, which requires strategies and procedures by the food industry to reduce the risk of compromise in facilities and processes that are significantly vulnerable.


title: Food and Drug Administration

text: The FDA also uses tactics of regulatory shaming, mainly through online publication of non-compliance, warning letters, and "shaming lists." Regulation by shaming harnesses firms' sensitivity to reputational damage. For example, in 2018, the agency published an online "black list," in which it named dozens of branded drug companies that are supposedly using unlawful or unethical means to attempt to impede competition from generic drug companies.


title: Food and Drug Administration

text: The FDA frequently works with other federal agencies, including the Department of Agriculture, the Drug Enforcement Administration, Customs and Border Protection, and the Consumer Product Safety Commission. They also often work with local and state government agencies in performing regulatory inspections and enforcement actions.


title: Food and Drug Administration

text: The regulation of food and dietary supplements by the Food and Drug Administration is governed by various statutes enacted by the United States Congress and interpreted by the FDA. Pursuant to the Federal Food, Drug, and Cosmetic Act and accompanying legislation, the FDA has authority to oversee the quality of substances sold as food in the United States, and to monitor claims made in the labeling of both the composition and the health benefits of foods.


title: Food and Drug Administration

text: The FDA subdivides substances that it regulates as food into various categories—including foods, food additives, added substances (man-made substances that are not intentionally introduced into food, but nevertheless end up in it), and dietary supplements. Dietary supplements or dietary ingredients include vitamins, minerals, herbs, amino acids, and. enzymes. Specific standards the FDA exercises differ from one category to the next. Furthermore, legislation had granted the FDA a variety of means to address violations of standards for a given substance category.


title: Food and Drug Administration

text: Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the FDA is responsible for ensuring that manufacturers and distributors of dietary supplements and dietary ingredients meet the current requirements. These manufacturers and distributors are not allowed to advertise their products in an adulterated way, and they are responsible for evaluating the safety and labeling of their product.


title: Food and Drug Administration

text: The FDA has a "Dietary Supplement Ingredient Advisory List" that includes ingredients that sometimes appear on dietary supplements but need further evaluation further. An ingredient is added to this list when it is excluded from use in a dietary supplement, does not appear to be an approved food additive or recognized as safe, and/or is subjected to the requirement for pre-market notification without having a satisfied requirement.


title: Food and Drug Administration

text: The FDA does not approve applied coatings used in the food processing industry. There is no review process to approve the composition of nonstick coatings; nor does the FDA inspect or test these materials. Through their governing of processes, however, the FDA does have a set of regulations that cover the formulation, manufacturing, and use of nonstick coatings. Hence, materials like Polytetrafluoroethylene (Teflon) are not, and cannot be, considered as FDA Approved, rather, they are "FDA Compliant" or "FDA Acceptable".


title: Food and Drug Administration

text: Medical countermeasures (MCMs) are products such as biologics and pharmaceutical drugs that can protect from or treat the health effects of a chemical, biological, radiological, or nuclear (CBRN) attack. MCMs can also be used for prevention and diagnosis of symptoms associated with CBRN attacks or threats. The FDA runs a program called the "FDA Medical Countermeasures Initiative" (MCMi), with programs funded by the federal government. It helps support "partner" agencies and organisations prepare for public health emergencies that could require MCMs.


title: Food and Drug Administration

text: The Center for Drug Evaluation and Research uses different requirements for the three main drug product types: new drugs, generic drugs, and over-the-counter drugs. A drug is considered "new" if it is made by a different manufacturer, uses different excipients or inactive ingredients, is used for a different purpose, or undergoes any substantial change. The most rigorous requirements apply to "new molecular entities": drugs that are not based on existing medications.


title: Food and Drug Administration

text: New drugs receive extensive scrutiny before FDA approval in a process called a new drug application (NDA). Under the Trump administration, the agency has worked to make the drug-approval process go faster. Critics, however, argue that the FDA standards are not sufficiently rigorous, allowing unsafe or ineffective drugs to be approved. New drugs are available only by prescription by default. A change to over-the-counter (OTC) status is a separate process, and the drug must be approved through an NDA first. A drug that is approved is said to be "safe and effective when used as directed".


title: Food and Drug Administration

text: Very rare, limited exceptions to this multi-step process involving animal testing and controlled clinical trials can be granted out of compassionate use protocols. This was the case during the 2015 Ebola epidemic with the use, by prescription and authorization, of ZMapp and other experimental treatments, and for new drugs that can be used to treat debilitating and/or very rare conditions for which no existing remedies or drugs are satisfactory, or where there has not been an advance in a long period of time. The studies are progressively longer, gradually adding more individuals as they progress from stage I to stage III, normally over a period of years, and normally involve drug companies, the government and its laboratories, and often medical schools and hospitals and clinics. However, any exceptions to the aforementioned process are subject to strict review and scrutiny and conditions, and are only given if a substantial amount of research and at least some preliminary human testing has shown that they are believed to be somewhat safe and possibly effective. (See FDA Special Protocol Assessment about Phase III trials.)


title: Food and Drug Administration

text: The FDA's Office of Prescription Drug Promotion reviews and regulates prescription drug advertising and promotion through surveillance activities and issuance of enforcement letters to pharmaceutical manufacturers. Advertising and promotion for over-the-counter drugs is regulated by the Federal Trade Commission. The FDA also empowers third-party enforcer-firms to engage in some regulatory oversight, e.g. the FDA expects pharmaceutical companies to make sure that third-party suppliers and labs abide by the agency's health and safety guidelines.


title: Food and Drug Administration

text: The drug advertising regulation contains two broad requirements: (1) a company may advertise or promote a drug only for the specific indication or medical use for which it was approved by FDA. Also, an advertisement must contain a "fair balance" between the benefits and the risks (side effects) of a drug.


title: Food and Drug Administration

text: After NDA approval, the sponsor must then review and report to the FDA every single patient adverse drug experience it learns of. They must report unexpected serious and fatal adverse drug events within 15 days, and other events on a quarterly basis. The FDA also receives directly adverse drug event reports through its MedWatch program. These reports are called "spontaneous reports" because reporting by consumers and health professionals is voluntary.


title: Food and Drug Administration

text: While this remains the primary tool of post-market safety surveillance, FDA requirements for post-marketing risk management are increasing. As a condition of approval, a sponsor may be required to conduct additional clinical trials, called Phase IV trials. In some cases, the FDA requires risk management plans called Risk Evaluation and Mitigation Strategies (REMS) for some drugs that require actions to be taken to ensure that the drug is used safely. For example, thalidomide can cause birth defects, but has uses that outweigh the risks if men and women taking the drugs do not conceive a child; a REMS program for thalidomide mandates an auditable process to ensure that people taking the drug take action to avoid pregnancy; many opioid drugs have REMS programs to avoid addiction and diversion of drugs. The drug isotretinoin has a REMS program called iPLEDGE.


title: Food and Drug Administration

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


title: Food and Drug Administration

text: In 1989, a major scandal erupted involving the procedures used by the FDA to approve generic drugs for sale to the public. Charges of corruption in generic drug approval first emerged in 1988 during the course of an extensive congressional investigation into the FDA. The oversight subcommittee of the United States House Energy and Commerce Committee resulted from a complaint brought against the FDA by Mylan Laboratories Inc. of Pittsburgh. When its application to manufacture generics were subjected to repeated delays by the FDA, Mylan, convinced that it was being discriminated against, soon began its own private investigation of the agency in 1987. Mylan eventually filed suit against two former FDA employees and four drug-manufacturing companies, charging that corruption within the federal agency resulted in racketeering and in violations of antitrust law. "The order in which new generic drugs were approved was set by the FDA employees even before drug manufacturers submitted applications" and, according to Mylan, this illegal procedure was followed to give preferential treatment to certain companies. During the summer of 1989, three FDA officials (Charles Y. Chang, David J. Brancato, Walter Kletch) pleaded guilty to criminal charges of accepting bribes from generic drugs makers, and two companies (Par Pharmaceutical and its subsidiary Quad Pharmaceuticals) pleaded guilty to giving bribes.


title: Food and Drug Administration

text: Furthermore, it was discovered that several manufacturers had falsified data submitted in seeking FDA authorization to market certain generic drugs. Vitarine Pharmaceuticals of New York, which sought approval of a generic version of the drug Dyazide, a medication for high blood pressure, submitted Dyazide, rather than its generic version, for the FDA tests. In April 1989, the FDA investigated 11 manufacturers for irregularities; and later brought that number up to 13. Dozens of drugs were eventually suspended or recalled by manufacturers. In the early 1990s, the U.S. Securities and Exchange Commission filed securities fraud charges against the Bolar Pharmaceutical Company, a major generic manufacturer based in Long Island, New York.


title: Food and Drug Administration

text: Over-the-counter (OTC) are drugs like aspirin that do not require a doctor's prescription. The FDA has a list of approximately 800 such approved ingredients that are combined in various ways to create more than 100,000 OTC drug products. Many OTC drug ingredients had been previously approved prescription drugs now deemed safe enough for use without a medical practitioner's supervision like ibuprofen.


title: Food and Drug Administration

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


title: Food and Drug Administration

text: During the coronavirus pandemic, FDA granted emergency use authorization for personal protective equipment (PPE), in vitro diagnostic equipment, ventilators and other medical devices.


title: Food and Drug Administration

text: On March 18, 2020, FDA inspectors postponed most foreign facility inspections and all domestic routine surveillance facility inspections. In contrast, the USDA's Food Safety and Inspection Service (FSIS) continued inspections of meatpacking plants, which resulted in 145 FSIS field employees who tested positive for COVID-19, and three who died.


title: Food and Drug Administration

text: The Center for Biologics Evaluation and Research is the branch of the FDA responsible for ensuring the safety and efficacy of biological therapeutic agents. These include blood and blood products, vaccines, allergenics, cell and tissue-based products, and gene therapy products. New biologics are required to go through a premarket approval process called a Biologics License Application (BLA), similar to that for drugs.


title: Food and Drug Administration

text: The original authority for government regulation of biological products was established by the 1902 Biologics Control Act, with additional authority established by the 1944 Public Health Service Act. Along with these Acts, the Federal Food, Drug, and Cosmetic Act applies to all biologic products, as well. Originally, the entity responsible for regulation of biological products resided under the National Institutes of Health; this authority was transferred to the FDA in 1972.


title: Food and Drug Administration

text: The Center for Devices and Radiological Health (CDRH) is the branch of the FDA responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices. The definition of a medical device is given in the FD&C Act, and it includes products from the simple toothbrush to complex devices such as implantable neurostimulators. CDRH also oversees the safety performance of non-medical devices that emit certain types of electromagnetic radiation. Examples of CDRH-regulated devices include cellular phones, airport baggage screening equipment, television receivers, microwave ovens, tanning booths, and laser products.


title: Food and Drug Administration

text: CDRH regulatory powers include the authority to require certain technical reports from the manufacturers or importers of regulated products, to require that radiation-emitting products meet mandatory safety performance standards, to declare regulated products defective, and to order the recall of defective or noncompliant products. CDRH also conducts limited amounts of direct product testing.


title: Food and Drug Administration

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


title: Food and Drug Administration

text: Cosmetics are regulated by the Center for Food Safety and Applied Nutrition, the same branch of the FDA that regulates food. Cosmetic products are not, in general, subject to premarket approval by the FDA unless they make "structure or function claims" that make them into drugs (see Cosmeceutical). However, all color additives must be specifically FDA approved before manufacturers can include them in cosmetic products sold in the U.S. The FDA regulates cosmetics labeling, and cosmetics that have not been safety tested must bear a warning to that effect.


title: Food and Drug Administration

text: According to the industry advocacy group the American Council on Science and Health, though the cosmetic industry is predominantly responsible in ensuring the safety of its products, the FDA also has the power to intervene when necessary to protect the public but in general does not require pre-market approval or testing. The ACSH says that companies are required to place a warning note on their products if they have not been tested and that experts in cosmetic ingredient reviews also play a role in monitoring safety through influence on the use of ingredients, but also lack legal authority. According to the ACSH, overall the organization has reviewed about 1,200 ingredients and has suggested that several hundred be restricted, but there is no standard or systemic method for reviewing chemicals for safety and a clear definition of what is meant by 'safety' so that all chemicals are tested on the same basis.


title: Food and Drug Administration

text: The Center for Veterinary Medicine (CVM) is a center of the FDA that regulates food additives and drugs that are given to animals. CVM regulates animal drugs, animal food including pet animal, and animal medical devices. The FDA's requirements to prevent the spread of bovine spongiform encephalopathy are also administered by CVM through inspections of feed manufacturers. CVM does not regulate vaccines for animals; these are handled by the United States Department of Agriculture.


title: Food and Drug Administration

text: The FDA regulates tobacco products with authority established by the 2009 Family Smoking Prevention and Tobacco Control Act. This Act requires color warnings on cigarette packages and printed advertising, and text warnings from the U.S. Surgeon General.


title: Food and Drug Administration

text: The nine new graphic warning labels were announced by the FDA in June 2011 and were scheduled to be required to appear on packaging by September 2012. The implementation date is uncertain, due to ongoing proceedings in the case of R.J. Reynolds Tobacco Co. v. U.S. Food and Drug Administration. R.J. Reynolds, Lorillard, Commonwealth Brands, Liggett Group and Santa Fe Natural Tobacco Company have filed suit in Washington, D.C. federal court claiming that the graphic labels are an unconstitutional way of forcing tobacco companies to engage in anti-smoking advocacy on the government's behalf.


title: Food and Drug Administration

text: A First Amendment lawyer, Floyd Abrams, is representing the tobacco companies in the case, contending requiring graphic warning labels on a lawful product cannot withstand constitutional scrutiny. The Association of National Advertisers and the American Advertising Federation have also filed a brief in the suit, arguing that the labels infringe on commercial free speech and could lead to further government intrusion if left unchallenged. In November 2011, Federal judge Richard Leon of the U.S. District Court for the District of Columbia temporarily halted the new labels, likely delaying the requirement that tobacco companies display the labels. The U.S. Supreme Court ultimately could decide the matter.


title: Food and Drug Administration

text: In July 2017, the FDA announced a plan that would reduce the current levels of nicotine permitted in tobacco cigarettes.


title: Food and Drug Administration

text: With acceptance of premarket notification 510(k) k033391 in January 2004, the FDA granted Dr. Ronald Sherman permission to produce and market medical maggots for use in humans or other animals as a prescription medical device. Medical maggots represent the first living organism allowed by the Food and Drug Administration for production and marketing as a prescription medical device.


title: Food and Drug Administration

text: In June 2004, the FDA cleared "Hirudo medicinalis" (medicinal leeches) as the second living organism to be used as a medical device.


title: Food and Drug Administration

text: In February 2011, President Barack Obama and Canadian Prime Minister Stephen Harper issued a "Declaration on a Shared Vision for Perimeter Security and Economic Competitiveness" and announced the creation of the Canada-United States Regulatory Cooperation Council (RCC) "to increase regulatory transparency and coordination between the two countries."


title: Food and Drug Administration

text: Under the RCC mandate, the FDA and Health Canada undertook a "first of its kind" initiative by selecting "as its first area of alignment common cold indications for certain over-the-counter antihistamine ingredients (GC 2013-01-10)."


title: Food and Drug Administration

text: A more recent example of the FDA's international work is their 2018 cooperation with regulatory and law-enforcement agencies worldwide through Interpol as part of Operation Pangea XI. The FDA targeted 465 websites that illegally sold potentially dangerous, unapproved versions of opioid, oncology, and antiviral prescription drugs to U.S. consumers. The agency focused on transaction laundering schemes in order to uncover the complex online drug network.


title: Food and Drug Administration

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


title: Food and Drug Administration

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


title: Food and Drug Administration

text: Up until the 20th century, there were few federal laws regulating the contents and sale of domestically produced food and pharmaceuticals, with one exception being the short-lived Vaccine Act of 1813. The history of the FDA can be traced to the latter part of the 19th century and the Division of Chemistry of the U.S. Department of Agriculture, which was itself derived from the Copyright and Patent Clause. Under Harvey Washington Wiley, appointed chief chemist in 1883, the Division began conducting research into the adulteration and misbranding of food and drugs on the American market. Wiley's advocacy came at a time when the public had become aroused to hazards in the marketplace by muckraking journalists like Upton Sinclair, and became part of a general trend for increased federal regulations in matters pertinent to public safety during the Progressive Era. The Biologics Control Act of 1902 was put in place after a diphtheria antitoxin derived from tetanus-contaminated serum caused the deaths of thirteen children in St. Louis, Missouri. The serum was originally collected from a horse named Jim who had contracted tetanus.


title: Food and Drug Administration

text: In June 1906, President Theodore Roosevelt signed into law the Pure Food and Drug Act of 1906, also known as the "Wiley Act" after its chief advocate. The Act prohibited, under penalty of seizure of goods, the interstate transport of food that had been "adulterated". The Act applied similar penalties to the interstate marketing of "adulterated" drugs, in which the "standard of strength, quality, or purity" of the active ingredient was not either stated clearly on the label or listed in the "United States Pharmacopeia" or the "National Formulary".


title: Food and Drug Administration

text: The responsibility for examining food and drugs for such "adulteration" or "misbranding" was given to Wiley's USDA Bureau of Chemistry. Wiley used these new regulatory powers to pursue an aggressive campaign against the manufacturers of foods with chemical additives, but the Chemistry Bureau's authority was soon checked by judicial decisions, which narrowly defined the bureau's powers and set high standards for proof of fraudulent intent. In 1927, the Bureau of Chemistry's regulatory powers were reorganized under a new USDA body, the Food, Drug, and Insecticide Administration. This name was shortened to the Food and Drug Administration (FDA) three years later.


title: Food and Drug Administration

text: By the 1930s, muckraking journalists, consumer protection organizations, and federal regulators began mounting a campaign for stronger regulatory authority by publicizing a list of injurious products that had been ruled permissible under the 1906 law, including radioactive beverages, the mascara Lash lure which caused blindness, and worthless "cures" for diabetes and tuberculosis. The resulting proposed law was unable to get through the Congress of the United States for five years, but was rapidly enacted into law following the public outcry over the 1937 Elixir Sulfanilamide tragedy, in which over 100 people died after using a drug formulated with a toxic, untested solvent.


title: Food and Drug Administration

text: President Franklin Delano Roosevelt signed the Federal Food, Drug, and Cosmetic Act into law on June 24, 1938. The new law significantly increased federal regulatory authority over drugs by mandating a pre-market review of the safety of all new drugs, as well as banning false therapeutic claims in drug labeling without requiring that the FDA prove fraudulent intent.


title: Food and Drug Administration

text: Soon after passage of the 1938 Act, the FDA began to designate certain drugs as safe for use only under the supervision of a medical professional, and the category of "prescription-only" drugs was securely codified into law by the Durham-Humphrey Amendment in 1951. These developments confirmed extensive powers for the FDA to enforce post-marketing recalls of ineffective drugs.


title: Food and Drug Administration

text: Outside of the US, the drug thalidomide was marketed for the relief of general nausea and morning sickness, but caused birth defects and even the death of thousands of babies when taken during pregnancy. American mothers were largely unaffected as Dr. Frances Oldham Kelsey of the FDA refused to authorize the medication for market. In 1962, the Kefauver-Harris Amendment to the FD&C Act was passed, which represented a "revolution" in FDA regulatory authority. The most important change was the requirement that all new drug applications demonstrate "substantial evidence" of the drug's efficacy for a marketed indication, in addition to the existing requirement for pre-marketing demonstration of safety. This marked the start of the FDA approval process in its modern form.


title: Food and Drug Administration

text: These reforms had the effect of increasing the time, and the difficulty, required to bring a drug to market. One of the most important statutes in establishing the modern American pharmaceutical market was the 1984 Drug Price Competition and Patent Term Restoration Act, more commonly known as the "Hatch-Waxman Act" after its chief sponsors. The act extended the patent exclusivity terms of new drugs, and tied those extensions, in part, to the length of the FDA approval process for each individual drug. For generic manufacturers, the Act created a new approval mechanism, the Abbreviated New Drug Application (ANDA), in which the generic drug manufacturer need only demonstrate that their generic formulation has the same active ingredient, route of administration, dosage form, strength, and pharmacokinetic properties ("bioequivalence") as the corresponding brand-name drug. This Act has been credited with, in essence, creating the modern generic drug industry.


title: Food and Drug Administration

text: Concerns about the length of the drug approval process were brought to the fore early in the AIDS epidemic. In the mid- and late 1980s, ACT-UP and other HIV activist organizations accused the FDA of unnecessarily delaying the approval of medications to fight HIV and opportunistic infections. Partly in response to these criticisms, the FDA issued new rules to expedite approval of drugs for life-threatening diseases, and expanded pre-approval access to drugs for patients with limited treatment options. All of the initial drugs approved for the treatment of HIV/AIDS were approved through these accelerated approval mechanisms. Frank Young, then commissioner of the FDA, was behind the Action Plan Phase II, established in August 1987 for quicker approval of AIDS medication.


title: Food and Drug Administration

text: In two instances, state governments have sought to legalize drugs that the FDA has not approved. Under the theory that federal law, passed pursuant to Constitutional authority, overrules conflicting state laws, federal authorities still claim the authority to seize, arrest, and prosecute for possession and sales of these substances, even in states where they are legal under state law. The first wave was the legalization by 27 states of laetrile in the late 1970s. This drug was used as a treatment for cancer, but scientific studies both before and after this legislative trend found it to be ineffective. The second wave concerned medical marijuana in the 1990s and 2000s. Though Virginia passed legislation allowing doctors to recommend cannabis for glaucoma or the side effects of chemotherapy, a more widespread trend began in California with the Compassionate Use Act of 1996.


title: Food and Drug Administration

text: When the FDA requested Endo Pharmaceuticals on June 8, 2017, to remove "oxymorphone hydrochloride" from the market, it was the first such request in FDA history.


title: Food and Drug Administration

text: The Critical Path Initiative is the FDA's effort to stimulate and facilitate a national effort to modernize the sciences through which FDA-regulated products are developed, evaluated, and manufactured. The Initiative was launched in March 2004, with the release of a report entitled Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products.


title: Food and Drug Administration

text: The Compassionate Investigational New Drug program was created after "Randall v. U.S." ruled in favor of Robert C. Randall in 1978, creating a program for medical marijuana.


title: Food and Drug Administration

text: A 2006 court case, "Abigail Alliance v. von Eschenbach", would have forced radical changes in FDA regulation of unapproved drugs. The Abigail Alliance argued that the FDA must license drugs for use by terminally ill patients with "desperate diagnoses," after they have completed Phase I testing. The case won an initial appeal in May 2006, but that decision was reversed by a March 2007 rehearing. The US Supreme Court declined to hear the case, and the final decision denied the existence of a right to unapproved medications.


title: Food and Drug Administration

text: Critics of the FDA's regulatory power argue that the FDA takes too long to approve drugs that might ease pain and human suffering faster if brought to market sooner. The AIDS crisis created some political efforts to streamline the approval process. However, these limited reforms were targeted for AIDS drugs, not for the broader market. This has led to the call for more robust and enduring reforms that would allow patients, under the care of their doctors, access to drugs that have passed the first round of clinical trials.


title: Food and Drug Administration

text: The widely publicized recall of Vioxx, a non-steroidal anti-inflammatory drug (NSAID) now estimated to have contributed to fatal heart attacks in thousands of Americans, played a strong role in driving a new wave of safety reforms at both the FDA rulemaking and statutory levels. Vioxx was approved by the FDA in 1999 and was initially hoped to be safer than previous NSAIDs, due to its reduced risk of intestinal tract bleeding. However, a number of pre- and post-marketing studies suggested that Vioxx might increase the risk of myocardial infarction, and this was conclusively demonstrated by results from the APPROVe trial in 2004.


title: Food and Drug Administration

text: Faced with numerous lawsuits, the manufacturer voluntarily withdrew it from the market. The example of Vioxx has been prominent in an ongoing debate over whether new drugs should be evaluated on the basis of their absolute safety, or their safety relative to existing treatments for a given condition. In the wake of the Vioxx recall, there were widespread calls by major newspapers, medical journals, consumer advocacy organizations, lawmakers, and FDA officials for reforms in the FDA's procedures for pre- and post-market drug safety regulation.


title: Food and Drug Administration

text: In 2006, a Congressional committee was appointed by the Institute of Medicine to review pharmaceutical safety regulation in the U.S. and to issue recommendations for improvements. The committee was composed of 16 experts, including leaders in clinical medicine medical research, economics, biostatistics, law, public policy, public health, and the allied health professions, as well as current and former executives from the pharmaceutical, hospital, and health insurance industries. The authors found major deficiencies in the current FDA system for ensuring the safety of drugs on the American market. Overall, the authors called for an increase in the regulatory powers, funding, and independence of the FDA. Some of the committee's recommendations were incorporated into drafts of the PDUFA IV amendment, which was signed into law as the Food and Drug Administration Amendments Act of 2007.


title: Food and Drug Administration

text: As of 2011, Risk Minimization Action Plans (RiskMAPS) have been created to ensure risks of a drug never outweigh the benefits of that drug within the post-marketing period. This program requires that manufacturers design and implement periodic assessments of their programs' effectiveness. The Risk Minimization Action Plans are set in place depending on the overall level of risk a prescription drug is likely to pose to the public.


title: Food and Drug Administration

text: Prior to the 1990s, only 20% of all drugs prescribed for children in the United States were tested for safety or efficacy in a pediatric population. This became a major concern of pediatricians as evidence accumulated that the physiological response of children to many drugs differed significantly from those drugs' effects on adults. Children react differently to the drugs because of many reasons, including size, weight, etc. There were several reasons that few medical trials were done with children. For many drugs, children represented such a small proportion of the potential market, that drug manufacturers did not see such testing as cost-effective.


title: Food and Drug Administration

text: Also, because children were thought to be ethically restricted in their ability to give informed consent, there were increased governmental and institutional hurdles to approval of these clinical trials, as well as greater concerns about legal liability. Thus, for decades, most medicines prescribed to children in the U.S. were done so in a non-FDA-approved, "off-label" manner, with dosages "extrapolated" from adult data through body weight and body-surface-area calculations.


title: Food and Drug Administration

text: An initial attempt by the FDA to address this issue was the 1994 FDA Final Rule on Pediatric Labeling and Extrapolation, which allowed manufacturers to add pediatric labeling information, but required drugs that had not been tested for pediatric safety and efficacy to bear a disclaimer to that effect. However, this rule failed to motivate many drug companies to conduct additional pediatric drug trials. In 1997, the FDA proposed a rule to require pediatric drug trials from the sponsors of New Drug Applications. However, this new rule was successfully preempted in federal court as exceeding the FDA's statutory authority.


title: Food and Drug Administration

text: While this debate was unfolding, Congress used the Food and Drug Administration Modernization Act of 1997 to pass incentives that gave pharmaceutical manufacturers a six-month patent term extension on new drugs submitted with pediatric trial data. The Best Pharmaceuticals for Children Act of 2007 reauthorized these provisions and allowed the FDA to request NIH-sponsored testing for pediatric drug testing, although these requests are subject to NIH funding constraints. In the Pediatric Research Equity Act of 2003, Congress codified the FDA's authority to mandate manufacturer-sponsored pediatric drug trials for certain drugs as a "last resort" if incentives and publicly funded mechanisms proved inadequate.


title: Food and Drug Administration

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


title: Food and Drug Administration

text: Since the 1990s, many successful new drugs for the treatment of cancer, autoimmune diseases, and other conditions have been protein-based biotechnology drugs, regulated by the Center for Biologics Evaluation and Research. Many of these drugs are extremely expensive; for example, the anti-cancer drug Avastin costs $55,000 for a year of treatment, while the enzyme replacement therapy drug Cerezyme costs $200,000 per year, and must be taken by Gaucher's Disease patients for life.


title: Food and Drug Administration

text: Biotechnology drugs do not have the simple, readily verifiable chemical structures of conventional drugs, and are produced through complex, often proprietary, techniques, such as transgenic mammalian cell cultures. Because of these complexities, the 1984 Hatch-Waxman Act did not include biologics in the Abbreviated New Drug Application (ANDA) process. This precluded the possibility of generic drug competition for biotechnology drugs. In February 2007, identical bills were introduced into the House to create an ANDA process for the approval of generic biologics, but were not passed.


title: Food and Drug Administration

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


title: Food and Drug Administration

text: The FDA has regulatory oversight over a large array of products that affect the health and life of American citizens. As a result, the FDA's powers and decisions are carefully monitored by several governmental and non-governmental organizations. A $1.8million 2006 Institute of Medicine report on pharmaceutical regulation in the U.S. found major deficiencies in the current FDA system for ensuring the safety of drugs on the American market. Overall, the authors called for an increase in the regulatory powers, funding, and independence of the FDA.


title: Food and Drug Administration

text: A 2022 article from Politico raised concerns that food is not a high priority at the FDA. The report explains the FDA has structural and leadership problems in the food division and is often deferential to industry. This might be attributed to lobbying and influence of big food companies in Washington, D.C.


title: Food and Drug Administration

text: During the COVID-19 pandemic, the FDA received criticism for punishing small distilleries that made hand sanitizers to help meet the unexpected demand. After receiving $14,000 fines from the FDA, some producers stated, "I wish we'd never done it. I will not put myself on this same chopping block again."


title: Pete Seeger

text: Peter Seeger (May 3, 1919 – January 27, 2014) was an American folk singer and social activist. A fixture on nationwide radio in the 1940s, Seeger also had a string of hit records during the early 1950s as a member of the Weavers, notably their recording of Lead Belly's "Goodnight, Irene", which topped the charts for 13 weeks in 1950. Members of the Weavers were blacklisted during the McCarthy Era. In the 1960s, Seeger re-emerged on the public scene as a prominent singer of protest music in support of international disarmament, civil rights, counterculture, workers' rights, and environmental causes.


title: Pete Seeger

text: A prolific songwriter, his best-known songs include "Where Have All the Flowers Gone?" (with additional lyrics by Joe Hickerson), "If I Had a Hammer (The Hammer Song)" (with Lee Hays of the Weavers), "Kisses Sweeter Than Wine" (also with Hays), and "Turn! Turn! Turn!", which have been recorded by many artists both in and outside the folk revival movement. "Flowers" was a hit recording for the Kingston Trio (1962); Marlene Dietrich, who recorded it in English, German and French (1962); and Johnny Rivers (1965). "If I Had a Hammer" was a hit for Peter, Paul and Mary (1962) and Trini Lopez (1963) while the Byrds had a number one hit with "Turn! Turn! Turn!" in 1965.


title: Pete Seeger

text: Seeger was one of the folk singers responsible for popularizing the spiritual "We Shall Overcome" (also recorded by Joan Baez and many other singer-activists), which became the acknowledged anthem of the civil rights movement, soon after folk singer and activist Guy Carawan introduced it at the founding meeting of the Student Nonviolent Coordinating Committee (SNCC) in 1960. In the PBS "American Masters" episode "", Seeger said it was he who changed the lyric from the traditional "We will overcome" to the more singable "We shall overcome".


title: Pete Seeger

text: Seeger was born on May 3, 1919, at the French Hospital, Midtown Manhattan. His family, which Seeger called "enormously Christian, in the Puritan, Calvinist New England tradition", traced its genealogy back over 200 years. A paternal ancestor, Karl Ludwig Seeger, a physician from Württemberg, Germany, had emigrated to America during the American Revolution and married into the old New England family of Parsons in the 1780s.


title: Pete Seeger

text: Seeger's father, the Harvard-trained composer and musicologist Charles Louis Seeger Jr., was born in Mexico City, Mexico, to American parents. Charles established the first musicology curriculum in the United States at the University of California, Berkeley, in 1913; helped found the American Musicological Society; and was a key founder of the academic discipline of ethnomusicology. Pete's mother, Constance de Clyver Seeger (née Edson), raised in Tunisia and trained at the Paris Conservatory of Music, was a concert violinist and later a teacher at the Juilliard School.


title: Pete Seeger

text: In 1912, his father, Charles Seeger, was hired to establish the music department at the University of California, Berkeley, but was forced to resign in 1918 because of his outspoken pacifism during World War I. Charles and Constance moved back east, making Charles's parents' estate in Patterson, New York, just north of New York City, their base of operations. When baby Pete was eighteen months old, they set out with him and his two older brothers in a homemade trailer to bring musical uplift to the working people in the American South. Upon their return, Constance taught violin and Charles taught composition at the New York Institute of Musical Art (later Juilliard), whose president, family friend Frank Damrosch, was Constance's adoptive "uncle." Charles also taught part-time at the New School for Social Research. Career and money tensions led to quarrels and reconciliations, but when Charles discovered Constance had opened a secret bank account in her own name, they separated, and Charles took custody of their three sons. Beginning in 1936, Charles held various administrative positions in the federal government's Farm Resettlement program, the WPA's Federal Music Project (1938–1940) and the wartime Pan American Union. After World War II, he taught ethnomusicology at the University of California, Berkeley, and Yale University.


title: Pete Seeger

text: Charles and Constance divorced when Pete was seven and in 1932 Charles married his composition student and assistant, Ruth Crawford, now considered by many to be one of the most important modernist composers of the 20th century. Deeply interested in folk music, Ruth had contributed musical arrangements to Carl Sandburg's extremely influential folk song anthology, the "American Songbag" (1927), and later created significant original settings for eight of Sandburg's poems. Pete's eldest brother, Charles Seeger III, was a radio astronomer, and his next older brother, John Seeger, taught in the 1950s at the Dalton School in Manhattan and was the principal from 1960 to 1976 at Fieldston Lower School in the Bronx. Pete's uncle, Alan Seeger, a noted American war poet ("I Have a Rendezvous with Death"), had been one of the first American soldiers to be killed in World War I. All four of Pete's half-siblings from his father's second marriage—Margaret (Peggy), Mike, Barbara, and Penelope (Penny)—became folk singers. Peggy Seeger, a well-known performer in her own right, married British folk singer and activist Ewan MacColl. Mike Seeger was a founder of the New Lost City Ramblers, one of whose members, John Cohen, married Pete's half-sister Penny, also a talented singer, who died young. Barbara Seeger joined her siblings in recording folk songs for children. In 1935, Pete attended Camp Rising Sun, an international leadership camp held every summer in upstate New York, which influenced his life's work. His final visit occurred in 2012.


title: Pete Seeger

text: At four, Seeger was sent away to boarding school, but came home two years later when his parents learned the school had failed to inform them he had contracted scarlet fever. He attended first and second grades in Nyack, New York, where his mother lived, before entering boarding school in Ridgefield, Connecticut. Despite being classical musicians, his parents did not press him to play an instrument. On his own, the otherwise bookish and withdrawn boy gravitated to the ukulele, becoming adept at entertaining his classmates with it while laying the basis for his subsequent remarkable audience rapport. At thirteen, Seeger enrolled in the Avon Old Farms School in Avon, Connecticut, from which he graduated in 1936. He was selected to attend Camp Rising Sun, the George E. Jonas Foundation's international summer leadership program. During the summer of 1936, while traveling with his father and stepmother, Pete heard the five-string banjo for the first time at the Mountain Dance and Folk Festival in western North Carolina near Asheville, organized by local folklorist, lecturer, and traditional music performer Bascom Lamar Lunsford, whom Charles Seeger had hired for Farm Resettlement music projects. The festival took place in a covered baseball field. There the Seegers:


title: Pete Seeger

text: watched square-dance teams from Bear Wallow, Happy Hollow, Cane Creek, Spooks Branch, Cheoah Valley, Bull Creek, and Soco Gap; heard the five-string banjo player Samantha Bumgarner; and family string bands, including a group of Indians from the Cherokee reservation who played string instruments and sang ballads. They wandered among the crowds who camped out at the edge of the field, hearing music being made there as well. As Lunsford's daughter would later recall, those country people "held the riches that Dad had discovered. They could sing, fiddle, pick the banjos, and guitars with traditional grace and style found nowhere else but deep in the mountains. I can still hear those haunting melodies drift over the ball park."


title: Pete Seeger

text: For the Seegers, experiencing the beauty of this music firsthand was a "conversion experience." Pete was deeply affected and, after learning basic strokes from Lunsford, spent much of the next four years trying to master the five-string banjo. The teenage Seeger also sometimes accompanied his parents to regular Saturday evening gatherings at the Greenwich Village loft of painter and art teacher Thomas Hart Benton and his wife Rita. Benton, a lover of Americana, played "Cindy" and "Old Joe Clark" with his students Charlie and Jackson Pollock; friends from the "hillbilly" recording industry; and avant-garde composers Carl Ruggles and Henry Cowell. It was at one of Benton's parties that Pete heard "John Henry" for the first time.


title: Pete Seeger

text: Seeger enrolled at Harvard College on a partial scholarship, but as he became increasingly involved with politics and folk music, his grades suffered and he lost his scholarship. He dropped out of college in 1938. He dreamed of a career in journalism and took courses in art as well. His first musical gig was leading students in folk singing at the Dalton School, where his aunt was principal. He polished his performance skills during a summer stint of touring New York state with the Vagabond Puppeteers (Jerry Oberwager, 22; Mary Wallace, 22; and Harriet Holtzman, 23), a traveling puppet theater "inspired by rural education campaigns of post-revolutionary Mexico." One of their shows coincided with a strike by dairy farmers. The group reprised its act in October in New York City. An article in the October 2, 1939, "Daily Worker" reported on the Puppeteers' six-week tour this way:


title: Pete Seeger

text: That fall, Seeger took a job in Washington, D.C., assisting Alan Lomax, a friend of his father's, at the Archive of American Folk Song of the Library of Congress. Seeger's job was to help Lomax sift through commercial "race" and "hillbilly" music and select recordings that best represented American folk music, a project funded by the music division of the Pan American Union (later the Organization of American States), of whose music division his father, Charles Seeger, was head (1938–53). Lomax also encouraged Seeger's folk-singing vocation, and Seeger was soon appearing as a regular performer on Alan Lomax and Nicholas Ray's weekly Columbia Broadcasting show "Back Where I Come From" (1940–41) alongside Josh White, Burl Ives, Lead Belly, and Woody Guthrie (whom he had first met at Will Geer's Grapes of Wrath benefit concert for migrant workers on March 3, 1940). "Back Where I Come From" was unique in having a racially integrated cast. The show was a success, but was not picked up by commercial sponsors for nationwide broadcasting because of its integrated cast. During the war, Seeger also performed on nationwide radio broadcasts by Norman Corwin.


title: Pete Seeger

text: In 1949, Seeger worked as the vocal instructor for the progressive City and Country School in Greenwich Village, New York.


title: Pete Seeger

text: In 1936, at the age of 17, Pete Seeger joined the Young Communist League (YCL), then at the height of its influence. In 1942, he became a member of the Communist Party USA (CPUSA) itself, but he left in 1949.


title: Pete Seeger

text: In the spring of 1941, the twenty-one-year-old Seeger performed as a member of the Almanac Singers along with Millard Lampell, Cisco Houston, Woody Guthrie, Butch Hawes and Bess Lomax Hawes, and Lee Hays. Seeger and the Almanacs cut several albums of 78s on Keynote and other labels: "Songs for John Doe" (recorded in late February or March and released in May 1941), "Talking Union", and an album each of sea shanties and pioneer songs. Written by Millard Lampell, "Songs for John Doe" was performed by Lampell, Seeger, and Hays, joined by Josh White and Sam Gary. It contained lines, such as "It wouldn't be much thrill to die for Du Pont in Brazil," that were sharply critical of Roosevelt's unprecedented peacetime draft (enacted in September 1940). This anti-war/anti-draft tone reflected the Communist Party line after the 1939 Molotov–Ribbentrop Pact, which maintained that the war was "phony" and a mere pretext for big American corporations to get Hitler to attack Soviet Russia. Seeger has said he believed this line of argument at the time, as did many fellow members of the Young Communist League (YCL). Though nominally members of the , which was allied with Roosevelt and more moderate liberals, the YCL's members still smarted from Roosevelt and Churchill's arms embargo on Loyalist Spain (which Roosevelt later called a mistake), and the alliance frayed in the confusing welter of events.


title: Pete Seeger

text: A June 16, 1941, review in "Time" magazine, which, under its owner, Henry Luce, had become very interventionist, denounced the Almanacs' "John Doe", accusing it of scrupulously echoing what it called "the mendacious Moscow tune" that "Franklin Roosevelt is leading an unwilling people into a J.P. Morgan war." Eleanor Roosevelt, a fan of folk music, reportedly found the album "in bad taste," though President Roosevelt, when the album was shown to him, merely observed, correctly, as it turned out, that few people would ever hear it. More alarmist was the reaction of eminent German-born Harvard Professor of Government Carl Joachim Friedrich, an adviser on domestic propaganda to the United States military. In a review in the June 1941 "Atlantic Monthly", entitled "The Poison in Our System," he pronounced "Songs for John Doe" "strictly subversive and illegal," "whether Communist or Nazi financed," and "a matter for the attorney general," observing further that "mere" legal "suppression" would not be sufficient to counteract this type of populist poison, the poison being folk music and the ease with which it could be spread.


title: Pete Seeger

text: While the U.S. had not officially declared war on the Axis powers in the summer of 1941, the country was energetically producing arms and ammunition for its allies overseas. Despite the boom in manufacturing this concerted rearming effort brought, African Americans were barred from working in defense plants. Racial tensions rose as Black labor leaders (such as A. Philip Randolph and Bayard Rustin) and their white allies began organizing protests and marches. To combat this social unrest, President Roosevelt issued Executive Order 8802 (the Fair Employment Act) on 25 June 1941. The order came three days after Hitler broke the non-aggression pact and invaded the Soviet Union, at which time the Communist Party quickly directed its members to get behind the draft and forbade participation in strikes for the duration of the war—angering some leftists. Copies of "Songs for John Doe" were removed from sale, and the remaining inventory destroyed, though a few copies may exist in the hands of private collectors. The Almanac Singers' "Talking Union" album, on the other hand, was reissued as an LP by Folkways (FH 5285A) in 1955 and is still available. The following year, the Almanacs issued "Dear Mr. President", an album in support of Roosevelt and the war effort. The title song, "Dear Mr. President", was a solo by Pete Seeger, and its lines expressed his lifelong credo:


title: Pete Seeger

text: Seeger's critics, however, continued to bring up the Almanacs' repudiated "Songs for John Doe". In 1942, a year after the "John Doe" album's brief appearance (and disappearance), the FBI decided that the now-pro-war Almanacs were still endangering the war effort by subverting recruitment. According to the New York "World Telegram" (February 14, 1942), Carl Friedrich's 1941 article "The Poison in Our System" was printed up as a pamphlet and distributed by the Council for Democracy (an organization that Friedrich and Henry Luce's right-hand man, C. D. Jackson, Vice President of "Time" magazine, had founded "to combat all the Nazi, fascist, communist, pacifist" antiwar groups in the United States).


title: Pete Seeger

text: Seeger served in the U.S. Army in the Pacific. He was trained as an airplane mechanic, but was reassigned to entertain the American troops with music. Later, when people asked him what he did in the war, he always answered: "I strummed my banjo." After returning from service, Seeger and others established People's Songs, conceived as a nationwide organization with branches on both coasts and designed to "create, promote and distribute songs of labor and the American People." With Pete Seeger as its director, People's Songs worked for the 1948 presidential campaign of Roosevelt's former Secretary of Agriculture and Vice President, Henry A. Wallace, who ran as a third-party candidate on the Progressive Party ticket. Despite having attracted enormous crowds nationwide, however, Wallace won only in New York City, and following the election, he was excoriated for accepting the help in his campaign of Communists and fellow travelers, such as Seeger and singer Paul Robeson.


title: Pete Seeger

text: Seeger had been a fervent supporter of the Republican forces in the Spanish Civil War. In 1943, with Tom Glazer and Bess and Baldwin Hawes, he recorded an album of 78s called "Songs of the Lincoln Battalion" on Moe Asch's Stinson label. This included such songs as "There's a Valley in Spain Called Jarama" and "Viva la Quince Brigada". In 1960, this collection was re-issued by Moe Asch as one side of a Folkways LP called "Songs of the Lincoln and International Brigades". On the other side was a reissue of the legendary "Six Songs for Democracy" (originally recorded in Barcelona in 1938 while bombs were falling), performed by Ernst Busch and a chorus of members of the Thälmann Battalion, made up of volunteers from Germany. The songs were "Moorsoldaten" ("Peat Bog Soldiers", composed by political prisoners of German concentration camps); "Die Thaelmann-Kolonne", "Hans Beimler", "Das Lied Von Der Einheitsfront" ("Song of the United Front" by Hanns Eisler and Bertolt Brecht), "Der Internationalen Brigaden" ("Song of the International Brigades"), and "Los cuatro generales" ("The Four Generals", known in English as "The Four Insurgent Generals").


title: Pete Seeger

text: As a self-described "split tenor" (between a tenor and a countertenor), Pete Seeger was a founding member of two highly influential folk groups: the Almanac Singers and the Weavers. The Almanac Singers, which Seeger co-founded in 1941 with Millard Lampell and Arkansas singer and activist Lee Hays, was a topical group, designed to function as a singing newspaper promoting the industrial unionization movement, racial and religious inclusion, and other progressive causes. Its personnel included, at various times: Woody Guthrie, Bess Lomax Hawes, Sis Cunningham, Josh White, and Sam Gary. As a controversial Almanac singer, the 21-year-old Seeger performed under the stage name "Pete Bowers" to avoid compromising his father's government career.


title: Pete Seeger

text: In 1950, the Almanacs were reconstituted as the Weavers, named after the title of an 1892 play by Gerhart Hauptmann, about a workers' strike (which contained the lines "We'll stand it no more, come what may!"). They did benefits for strikers, at which they sang songs such as "Talking Union", about the struggles for unionisation of industrial workers such as miners and automobile workers. Besides Pete Seeger (performing under his own name), members of the Weavers included charter Almanac member Lee Hays, Ronnie Gilbert, and Fred Hellerman; later Frank Hamilton, Erik Darling, and Bernie Krause serially took Seeger's place. In the atmosphere of the 1950s red scare, the Weavers' repertoire had to be less overtly topical than that of the Almanacs had been, and its progressive message was couched in indirect language—arguably rendering it even more powerful. The Weavers on occasion performed in tuxedos (unlike the Almanacs, who had dressed informally) and their managers refused to let them perform at political venues. The Weavers' string of major hits began with "On Top of Old Smoky" and an arrangement of Lead Belly's signature waltz, "Goodnight, Irene", which topped the charts for 13 weeks in 1950 and was covered by many other pop singers. On the flip side of "Irene" was the Israeli song "Tzena, Tzena, Tzena". Other Weavers hits included "Dusty Old Dust" ("So Long It's Been Good to Know You" by Woody Guthrie), "Kisses Sweeter Than Wine" (by Hays, Seeger, and Lead Belly), and the Zulu song by Solomon Linda, "Wimoweh" (about Shaka), among others.


title: Pete Seeger

text: The Weavers' performing career was abruptly derailed in 1953, at the peak of their popularity, when blacklisting prompted radio stations to refuse to play their records and all their bookings were canceled. They briefly returned to the stage, however, at a sold-out reunion at Carnegie Hall in 1955 and in a subsequent reunion tour, which produced a hit version of Merle Travis's "Sixteen Tons", as well as LPs of their concert performances. "Kumbaya", a Gullah black spiritual dating from slavery days, was also introduced to wide audiences by Pete Seeger and the Weavers (in 1959), becoming a staple of Boy and Girl Scout campfires.


title: Pete Seeger

text: In the late 1950s, the Kingston Trio was formed in direct imitation of (and homage to) the Weavers, covering much of the latter's repertoire, though with a more buttoned-down, uncontroversial, and mainstream collegiate persona. The Kingston Trio produced another phenomenal succession of "Billboard" chart hits and, in its turn, spawned a legion of imitators, laying the groundwork for the 1960s commercial folk revival.


title: Pete Seeger

text: In the documentary film "" (2007), Seeger states that he resigned from the Weavers when the three other band members agreed to perform a jingle for a cigarette commercial.


title: Pete Seeger

text: In 1948, Seeger wrote the first version of his now-classic "How to Play the Five-String Banjo", a book that many banjo players credit with starting them off on the instrument. He went on to invent the "long-neck" or "Seeger" banjo. This instrument is three frets longer than a typical banjo, is slightly longer than a bass guitar at 25 frets, and is tuned a minor third lower than the normal 5-string banjo. Hitherto strictly limited to the Appalachian region, the five-string banjo became known nationwide as the American folk instrument par excellence, largely thanks to Seeger's championing of and improvements to it. According to an unnamed musician quoted in David King Dunaway's biography, "by nesting a resonant chord between two precise notes, a melody note and a chiming note on the fifth string," Pete Seeger "gentrified" the more percussive traditional Appalachian "frailing" style, "with its vigorous hammering of the forearm and its percussive rapping of the fingernail on the banjo head." Although what Dunaway's informant describes is the age-old droned frailing style, the implication is that Seeger made this more acceptable to mass audiences by omitting some of its percussive complexities, while presumably still preserving the characteristic driving rhythmic quality associated with the style.


title: Pete Seeger

text: From the late 1950s on, Seeger also accompanied himself on the 12-string guitar, an instrument of Mexican origin that had been associated with Lead Belly, who had styled himself "the King of the 12-String Guitar." Seeger's distinctive custom-made guitars had a triangular soundhole. He combined the long scale length (approximately 28") and capo-to-key techniques that he favored on the banjo with a variant of drop-D (DADGBE) tuning, tuned two whole steps down with very heavy strings, which he played with thumb and finger picks.


title: Pete Seeger

text: In 1956, then "Peter" Seeger (see film credits) and his wife, Toshi, traveled to Port of Spain, Trinidad, to seek out information on the steelpan, steel drum, or "ping-pong" as it was sometimes called. The two searched out a local panyard director, Isaiah, and proceeded to film the construction, tuning and playing of the then-new national instrument of Trinidad and Tobago. He was attempting to include the unique flavor of the steelpan in American folk music.


title: Pete Seeger

text: In the 1950s, and indeed consistently throughout his life, Seeger continued his support of civil and labor rights, racial equality, international understanding, and anti-militarism (all of which had characterized the Wallace campaign), and he continued to believe that songs could help people achieve these goals. However, with the ever-growing revelations of Joseph Stalin's atrocities and the Hungarian Revolution of 1956, he became increasingly disillusioned with Soviet Communism. He left the CPUSA in 1949, but remained friends with some who did not leave it, although he argued with them about it.


title: Pete Seeger

text: On August 18, 1955, Seeger was subpoenaed to testify before the House Un-American Activities Committee (HUAC). Alone among the many witnesses after the 1950 conviction and imprisonment of the Hollywood Ten for contempt of Congress, Seeger refused to plead the Fifth Amendment (which would have asserted that his testimony might be self-incriminating) and instead, as the Hollywood Ten had done, refused to name personal and political associations on the grounds that this would violate his First Amendment rights: "I am not going to answer any questions as to my association, my philosophical or religious beliefs or my political beliefs, or how I voted in any election, or any of these private affairs. I think these are very improper questions for any American to be asked, especially under such compulsion as this." Seeger's refusal to answer questions that he believed violated his fundamental constitutional rights led to a March 26, 1957, indictment for contempt of Congress; for some years, he had to keep the federal government apprised of where he was going any time he left the Southern District of New York. He was convicted in a jury trial of contempt of Congress in March 1961, and sentenced to ten one-year terms in jail (to be served simultaneously), but in May 1962, an appeals court ruled the indictment to be flawed and overturned his conviction.


title: Pete Seeger

text: In 1960, the San Diego school board told him that he could not play a scheduled concert at a high school unless he signed an oath pledging that the concert would not be used to promote a communist agenda or an overthrow of the government. Seeger refused, and the American Civil Liberties Union obtained an injunction against the school district, allowing the concert to go on as scheduled. Almost 50 years later, in February 2009, the San Diego School District officially extended an apology to Seeger for the actions of its predecessors.


title: Pete Seeger

text: To earn money during the blacklist period of the late 1950s and early 1960s, Seeger worked gigs as a music teacher in schools and summer camps, and traveled the college campus circuit. He also recorded as many as five albums a year for Moe Asch's Folkways Records label. As the nuclear disarmament movement picked up steam in the late 1950s and early 1960s, Seeger's anti-war songs, such as "Where Have All the Flowers Gone?" (co-written with Joe Hickerson), "Turn! Turn! Turn!" adapted from the Book of Ecclesiastes, and "The Bells of Rhymney" by the Welsh poet Idris Davies (1957), gained wide currency. Seeger was the first person to make a studio recording of "Last Night I Had the Strangest Dream" in 1956. Seeger also was closely associated with the Civil Rights Movement and in 1963 helped organize a landmark Carnegie Hall concert, featuring the youthful Freedom Singers, as a benefit for the Highlander Folk School in Tennessee. This event, and Martin Luther King Jr.'s March on Washington for Jobs and Freedom in August of that same year, brought the civil rights anthem "We Shall Overcome" to wide audiences. He sang it on the 50-mile walk from Selma to Montgomery, Alabama, along with 1,000 other marchers.


title: Pete Seeger

text: By this time, Seeger was a senior figure in the 1960s folk revival centered in Greenwich Village, as a longtime columnist in "Sing Out!", the successor to the People's Songs "Bulletin", and as a founder of the topical "Broadside" magazine. To describe the new crop of politically committed folk singers, he coined the phrase "Woody's children," alluding to his associate and traveling companion, Woody Guthrie, who by this time had become a legendary figure. This urban folk-revival movement, a continuation of the activist tradition of the 1930s and 1940s and of People's Songs, used adaptations of traditional tunes and lyrics to effect social change, a practice that goes back to the Industrial Workers of the World or Wobblies' "Little Red Song Book", compiled by Swedish-born union organizer Joe Hill (1879–1915). (The "Little Red Song Book" had been a favorite of Woody Guthrie, who was known to carry it around.)


title: Pete Seeger

text: Seeger toured Australia in 1963. His single "Little Boxes", written by Malvina Reynolds, was number one in the nation's Top 40. That tour sparked a folk boom throughout the country at a time when popular music tastes, post–Kennedy assassination, competed between folk, the surfing craze, and the British rock boom that gave the world the Beatles and The Rolling Stones, among others. Folk clubs sprang up all over the nation; folk performers were accepted in established venues; Australian performers singing Australian folk songs—many of their own composing—emerged in concerts and festivals, on television, and on recordings; and overseas performers were encouraged to tour Australia.


title: Pete Seeger

text: The long television blacklist of Seeger began to end in the mid-1960s when he hosted a regionally broadcast educational folk-music television show, "Rainbow Quest". Among his guests were Johnny Cash, June Carter, Reverend Gary Davis, Mississippi John Hurt, Doc Watson, the Stanley Brothers, Elizabeth Cotten, Patrick Sky, Buffy Sainte-Marie, Tom Paxton, Judy Collins, Hedy West, Donovan, The Clancy Brothers, Richard Fariña and Mimi Fariña, Sonny Terry and Brownie McGhee, Mamou Cajun Band, Bernice Johnson Reagon, the Beers Family, Roscoe Holcomb, Malvina Reynolds, Sonia Malkine, and Shawn Phillips. Thirty-nine hour-long programs were recorded at WNJU's Newark studios in 1965 and 1966, produced by Seeger and his wife Toshi, with Sholom Rubinstein. The Smothers Brothers ended Seeger's national blacklisting by broadcasting him singing "Waist Deep in the Big Muddy" on their CBS variety show on February 25, 1968, after his similar performance in September 1967 was censored by CBS.


title: Pete Seeger

text: In November 1976, Seeger wrote and recorded the anti-death penalty song "Delbert Tibbs", about the death-row inmate Delbert Tibbs, who was later exonerated. Seeger wrote the music and selected the words from poems written by Tibbs.


title: Pete Seeger

text: Seeger also supported the Jewish Camping Movement. He came to Surprise Lake Camp in Cold Spring, New York, over the summer many times. He sang and inspired countless campers.


title: Pete Seeger

text: Pete Seeger was one of the earliest backers of Bob Dylan; he was responsible for urging A&R man John Hammond to produce Dylan's first LP on Columbia, and for inviting him to perform at the Newport Folk Festival, of which Seeger was a board member. There was a widely repeated story that Seeger was so upset over the extremely loud amplified sound that Dylan, backed by members of the Butterfield Blues Band, brought into the 1965 Newport Folk Festival that he threatened to disconnect the equipment. There are multiple versions of what went on, some fanciful. What is certain is that tensions had been running high between Dylan's manager Albert Grossman and Festival board members (who besides Seeger also included Theodore Bikel, Bruce Jackson, Alan Lomax, festival MC Peter Yarrow, and George Wein) over the scheduling of performers and other matters. Two days earlier, there had been a scuffle and a brief exchange of blows between Grossman and Alan Lomax, and the board, in an emergency session, had voted to ban Grossman from the grounds, but had backed off when George Wein pointed out that Grossman also managed highly popular draws Odetta and Peter, Paul and Mary. Seeger has been portrayed as a folk "purist" who was one of the main opponents to Dylan's "going electric," but when asked in 2001 about how he recalled his "objections" to the electric style, he said:


title: Pete Seeger

text: I couldn't understand the words. I wanted to hear the words. It was a great song, "Maggie's Farm," and the sound was distorted. I ran over to the guy at the controls and shouted, "Fix the sound so you can hear the words." He hollered back, "This is the way they want it." I said "Damn it, if I had an axe, I'd cut the cable right now." But I was at fault. I was the MC, and I could have said to the part of the crowd that booed Bob, "you didn't boo Howlin' Wolf yesterday. He was electric!" Though I still prefer to hear Dylan acoustic, some of his electric songs are absolutely great. Electric music is the vernacular of the second half of the twentieth century, to use my father's old term.


title: Pete Seeger

text: A longstanding opponent of the arms race and of the Vietnam War, Seeger satirically attacked then-President Lyndon Johnson with his 1966 recording, on the album "Dangerous Songs!?", of Len Chandler's children's song "Beans in My Ears". Beyond Chandler's lyrics, Seeger said that "Mrs. Jay's little son Alby" had "beans in his ears," which, as the lyrics imply, ensures that a person does not hear what is said to them. To those opposed to continuing the Vietnam War, the phrase implied that "Alby Jay," a loose pronunciation of Johnson's nickname "LBJ," did not listen to anti-war protests as he too had "beans in his ears."


title: Pete Seeger

text: During 1966, Seeger and Malvina Reynolds took part in environmental activism. The album "God Bless the Grass" was released in January of that year and became the first album in history wholly dedicated to songs about environmental issues. Their politics were informed by the same ideologies of nationalism, populism, and criticism of big business.


title: Pete Seeger

text: Seeger attracted wider attention starting in 1967 with his song "Waist Deep in the Big Muddy", about a captain—referred to in the lyrics as "the big fool"—who drowned while leading a platoon on maneuvers in Louisiana during World War II. With its lyrics about a platoon being led into danger by an ignorant captain, the song's anti-war message was obvious—the line "the big fool said to push on" is repeated several times. In the face of arguments with the management of CBS about whether the song's political weight was in keeping with the usually light-hearted entertainment of the "Smothers Brothers Comedy Hour", the final lines were "Every time I read the paper/those old feelings come on/We are waist deep in the Big Muddy and the big fool says to push on." The lyrics could be interpreted as an allegory of Johnson as the "big fool" and the Vietnam War as the foreseeable danger. Although the performance was cut from the September 1967 show, after wide publicity, it was broadcast when Seeger appeared again on the Smothers' Brothers show on February 25, 1968.


title: Pete Seeger

text: At the November 15, 1969, Vietnam Moratorium March on Washington, DC, Seeger led 500,000 protesters in singing John Lennon's song "Give Peace a Chance" as they rallied across from the White House. Seeger's voice carried over the crowd, interspersing phrases like "Are you listening, Nixon?" between the choruses of protesters singing, "All we are saying ... is give peace a chance."


title: Pete Seeger

text: Inspired by Woody Guthrie, whose guitar was labeled "This machine kills fascists," Seeger's banjo was emblazoned with the motto "This Machine Surrounds Hate and Forces It to Surrender."


title: Pete Seeger

text: In the documentary film "The Power of Song", Seeger mentions that he and his family visited North Vietnam in 1972.


title: Pete Seeger

text: Being a supporter of progressive labor unions, Seeger had supported Ed Sadlowski in his bid for the presidency of the United Steelworkers of America. In 1977, Seeger appeared at a fundraiser in Homestead, Pennsylvania. In 1978, Seeger joined American folk, blues, and jazz singer Barbara Dane at a rally in New York for striking coal miners. He also headlined a benefit concert—with bluegrass artist Hazel Dickens—for the striking coal miners of Stearns, Kentucky, at the Lisner Auditorium in Washington, D.C. on June 8, 1979.


title: Pete Seeger

text: In 1980, Pete Seeger performed in Cambridge, Massachusetts. The performance was later released by Smithsonian Folkways as the album "Singalong Sanders Theater, 1980".


title: Pete Seeger

text: In 1966, Seeger and his wife Toshi founded the Hudson River Sloop Clearwater, a nonprofit organization based in Poughkeepsie, New York, that sought to protect the Hudson River and surrounding wetlands and waterways through advocacy and public education. It constructed a floating ambassador for this environmental mission, the sloop "Clearwater", and began an annual music and environmental festival, today known as the Great Hudson River Revival.


title: Pete Seeger

text: In 1982, Seeger performed at a benefit concert for the 1982 demonstrations in Poland against the Polish government. His biographer David Dunaway considers this the first public manifestation of Seeger's decades-long personal dislike of communism in its Soviet form. In the late 1980s, Seeger also expressed disapproval of violent revolutions, remarking to an interviewer that he was really in favor of incremental change and that "the most lasting revolutions are those that take place over a period of time." In his autobiography "Where Have All the Flowers Gone" (1993, 1997, reissued in 2009), Seeger wrote, "Should I apologize for all this? I think so." He went on to put his thinking in context:


title: Pete Seeger

text: How could Hitler have been stopped? Litvinov, the Soviet delegate to the League of Nations in '36, proposed a worldwide quarantine but got no takers. For more on those times check out pacifist Dave Dellinger's book, "From Yale to Jail ... " At any rate, today I'll apologize for a number of things, such as thinking that Stalin was merely a "hard driver" and not a "supremely cruel misleader." I guess anyone who calls himself a Christian should be prepared to apologize for the Inquisition, the burning of heretics by Protestants, the slaughter of Jews and Muslims by Crusaders. White people in the U.S.A. ought to apologize for stealing land from Native Americans and enslaving blacks. Europeans could apologize for worldwide conquests, Mongolians for Genghis Khan. And supporters of Roosevelt could apologize for his support of Somoza, of Southern White Democrats, of Franco Spain, for putting Japanese Americans in concentration camps. Who should my granddaughter Moraya apologize to? She's part African, part European, part Chinese, part Japanese, part Native American. Let's look ahead.


title: Pete Seeger

text: call myself a communist, because communism is no more what Russia made of it than Christianity is what the churches make of it."


title: Pete Seeger

text: In later years, as the aging Seeger began to garner awards and recognition for his lifelong activism, he also found himself criticized once again for his opinions and associations of the 1930s and 1940s. In 2006, David Boaz—Voice of America and NPR commentator and president of the libertarian Cato Institute—wrote an opinion piece in "The Guardian", entitled "Stalin's Songbird," in which he excoriated "The New Yorker" and "The New York Times" for lauding Seeger. He characterized Seeger as "someone with a longtime habit of following the party line" who had only "eventually" parted ways with the CPUSA. In support of this view, he quoted lines from the Almanac Singers' May 1941 "Songs for John Doe", contrasting them darkly with lines supporting the war from "Dear Mr. President", issued in 1942, after the United States and the Soviet Union had entered the war.


title: Pete Seeger

text: In 2007, in response to criticism from historian Ron Radosh, a former Trotskyite who now writes for the conservative "National Review," Seeger wrote a song condemning Stalin, "Big Joe Blues":


title: Pete Seeger

text: The song was accompanied by a letter to Radosh, in which Seeger stated, "I think you're right, I should have asked to see the gulags when I was in U.S.S.R. [in 1965]."


title: Pete Seeger

text: On March 16, 2007, Pete Seeger, his sister Peggy, his brothers Mike and John, his wife Toshi, and other family members spoke and performed at a symposium and concert sponsored by the American Folklife Center in honor of the Seeger family, held at the Library of Congress in Washington, D.C., where Pete Seeger had been employed by the Archive of American Folk Song 67 years earlier.


title: Pete Seeger

text: In September 2008, Appleseed Recordings released "At 89", Seeger's first studio album in 12 years. On September 29, 2008, the 89-year-old singer-activist, once banned from commercial TV, made a rare national TV appearance on the "Late Show with David Letterman", singing "Take It From Dr. King".


title: Pete Seeger

text: On January 18, 2009, Seeger and his grandson Tao Rodríguez-Seeger joined Bruce Springsteen and the crowd in singing the Woody Guthrie song "This Land Is Your Land" in the finale of Barack Obama's inaugural concert in Washington, D.C. The performance was noteworthy for the inclusion of two verses not often included in the song, one about a "private property" sign the narrator cheerfully ignores, and the other making a passing reference to a Depression-era relief office. The former's final line, however, "This land was made for you and me," is modified to "That side was made for you and me."


title: Pete Seeger

text: Over the years, he lent his fame to support numerous environmental organizations, including South Jersey's Bayshore Center, the home of New Jersey's tall ship, the oyster schooner "A.J. Meerwald". Seeger's benefit concerts helped raise funds for groups so they could continue to educate and spread environmental awareness. On May 3, 2009, at the Clearwater Concert, dozens of musicians gathered in New York at Madison Square Garden to celebrate Seeger's 90th birthday (which was later televised on PBS during the summer), ranging from Dave Matthews, John Mellencamp, Billy Bragg, Bruce Springsteen, Tom Morello, Eric Weissberg, Ani DiFranco and Roger McGuinn to Joan Baez, Richie Havens, Joanne Shenandoah, R. Carlos Nakai, Bill Miller, Joseph Fire Crow, Margo Thunderbird, Tom Paxton, Ramblin' Jack Elliott, and Arlo Guthrie. Cuban singer-songwriter Silvio Rodríguez was also invited to appear, but his visa was not approved in time by the United States government. Consistent with Seeger's longtime advocacy for environmental concerns, the proceeds from the event benefited the Hudson River Sloop Clearwater, a non-profit organization founded by Seeger in 1966, to defend and restore the Hudson River. Seeger's 90th birthday was also celebrated at The College of Staten Island on May 4.


title: Pete Seeger

text: On September 19, 2009, Seeger made his first appearance at the 52nd Monterey Jazz Festival, which was particularly notable because the festival does not normally feature folk artists.


title: Pete Seeger

text: In 2010, still active at the age of 91, Seeger co-wrote and performed the song """God's Counting on Me, God's Counting on You" with Lorre Wyatt, commenting on the Deepwater Horizon oil spill. A performance of the song by Seeger, Wyatt, and friends was recorded and filmed aboard the sloop "Clearwater" in August for a single and video produced by Richard Barone and Matthew Billy, released on election day, November 6, 2012.


title: Pete Seeger

text: On October 21, 2011, at age 92, Pete Seeger was part of a solidarity march with Occupy Wall Street to Columbus Circle in New York City. The march began with Seeger and fellow musicians exiting Symphony Space (95th and Broadway), where they had performed as part of a benefit for Seeger's Clearwater organization. Thousands of people crowded Pete Seeger by the time they reached Columbus Circle, where he performed with his grandson, Tao Rodríguez-Seeger, Arlo Guthrie, David Amram, and other celebrated musicians. The event, promoted under the name OccupyTheCircle, was livestreamed, and was dubbed by some "the Pete Seeger March."


title: Pete Seeger

text: In January 2012, Seeger joined the Rivertown Kids in paying tribute to his friend Bob Dylan, performing Dylan's "Forever Young" on the Amnesty International album "Chimes of Freedom." This song, Seeger's last single, marked Seeger's only music video, which went viral in the wake of his death two years later.


title: Pete Seeger

text: On December 14, 2012, Seeger performed, along with Harry Belafonte, Jackson Browne, Common, and others, at a concert to bring awareness to the 37-year-long ordeal of Native American activist Leonard Peltier. The concert was held at the Beacon Theater in New York City.


title: Pete Seeger

text: On April 9, 2013, Hachette Audio Books issued an audiobook entitled "Pete Seeger: The Storm King; Stories, Narratives, Poems". This two-CD spoken-word work was conceived of and produced by noted percussionist Jeff Haynes and presents Pete Seeger telling the stories of his life against a background of music performed by more than 40 musicians of varied genres. The launch of the audiobook was held at the on April 11, 2013, to an enthusiastic audience of around two hundred people, and featured many of the musicians from the project (among them Samite, Dar Williams, Dave Eggar, and Richie Stearns of the Horse Flies and Natalie Merchant) performing live under the direction of producer and percussionist Haynes. April 15, 2013, Sirius XM Book Radio presented the concert as a special episode of "Cover to Cover Live with Maggie Linton and Kim Alexander," entitled "Pete Seeger: The Storm King and Friends."


title: Pete Seeger

text: On August 9, 2013, one month widowed, Seeger was in New York City for the 400-year commemoration of the Two Row Wampum Treaty between the Iroquois and the Dutch. On an interview he gave that day to Democracy Now!, Seeger sang "I Come and Stand at Every Door", as it was also the 68th anniversary of the bombing of Nagasaki.


title: Pete Seeger

text: On September 21, 2013, Pete Seeger performed at Farm Aid at the Saratoga Performing Arts Center in Saratoga Springs, New York. Joined by Wille Nelson, Neil Young, John Mellencamp, and Dave Matthews, he sang "This Land Is Your Land", and included a verse he said he had written specifically for the Farm Aid concert.


title: Pete Seeger

text: Seeger married Toshi Aline Ohta in 1943, whom he credited with being the support that helped make the rest of his life possible. The couple remained married until Toshi's death in July 2013. Their first child, Peter Ōta Seeger, was born in 1944 and died at six months, while Pete was deployed overseas. Pete never saw him. They went on to have three more children: Daniel (an accomplished photographer and filmmaker), Mika (a potter and muralist), and Tinya (a potter), as well as grandchildren Tao Rodríguez-Seeger (a musician), Cassie (an artist), Kitama Cahill-Jackson (a psychotherapist), Moraya (a marriage and family therapist married to the NFL player Chris DeGeare), Penny, and Isabelle, and great-grandchildren Dio and Gabel. Tao, a folk musician in his own right, sings and plays guitar, banjo, and harmonica with the Mammals. Kitama Jackson is a documentary filmmaker who was associate producer of the 2007 PBS documentary "".


title: Pete Seeger

text: When asked by Beliefnet about his religious or spiritual beliefs, and his definition of God, Seeger replied:


title: Pete Seeger

text: Seeger lived in Beacon, New York. He and Toshi purchased their land in 1949 and lived there first in a trailer, then in a log cabin they built themselves. He remained engaged politically and maintained an active lifestyle in the Hudson Valley region of New York throughout his life. For years during the Iraq War, Seeger maintained a weekly protest vigil alongside Route 9 in Wappingers Falls, near his home. He told a "New York Times" reporter that "working for peace was like adding sand to a basket on one side of a large scale, trying to tip it one way despite enormous weight on the opposite side." He went on to say, "Some of us try to add more sand by teaspoons ... It's leaking out as fast as it goes in and they're all laughing at us. But we're still getting people with teaspoons. I get letters from people saying, 'I'm still on the teaspoon brigade.'"


title: Pete Seeger

text: Toshi died in Beacon on July 9, 2013, at the age of 91, and Pete died at New York–Presbyterian Hospital in New York City on January 27, 2014, at the age of 94.


title: Pete Seeger

text: Response and reaction to Seeger's death quickly poured in. President Barack Obama noted that Seeger had been called "America's tuning fork" and that he believed in "the power of song" to bring social change, "Over the years, Pete used his voice and his hammer to strike blows for workers' rights and civil rights; world peace and environmental conservation, and he always invited us to sing along. For reminding us where we come from and showing us where we need to go, we will always be grateful to Pete Seeger." Folksinger and fellow activist Billy Bragg wrote that "Pete believed that music could make a difference. Not change the world, he never claimed that – he once said that if music could change the world he'd only be making music – but he believed that while music didn't have agency, it did have the power to make a difference." Bruce Springsteen said of Seeger's death, "I lost a great friend and a great hero last night, Pete Seeger," before performing "We Shall Overcome" while on tour in South Africa.


title: The Walking Dead (comic book)

text: The Walking Dead is an American post-apocalyptic comic book series created by writer Robert Kirkman and artist Tony Moore – who was the artist on the first six issues and cover artist for the first twenty-four – with art on the remainder of the series by Charlie Adlard. Beginning in 2003 and published by Image Comics, the series ran for 193 issues, with Kirkman unexpectedly ending the series in 2019. Apart from a few specials, the comic was published primarily in black and white. It began publishing colorized versions issue by issue, colored by Dave McCaig, starting in October 2020.


title: The Walking Dead (comic book)

text: The comic book series focuses on Rick Grimes, a Kentucky deputy who is shot in the line of duty and awakens from a coma in a zombie apocalypse that has resulted in a state-wide quarantine. After joining with some other survivors, he gradually takes on the role of leader of a community as it struggles to survive the zombie apocalypse. "The Walking Dead" received the 2007 and 2010 Eisner Award for Best Continuing Series at San Diego Comic-Con International.


title: The Walking Dead (comic book)

text: The AMC television series "The Walking Dead" (2010–2022) loosely follows the storyline of the comic book. The "Walking Dead" franchise has also spawned multiple additional media properties, including two companion television series ("Fear the Walking Dead" and ""), eight webisode series, video games (starting with "The Walking Dead: The Game"), and various additional publications, including novels (starting with "").


title: The Walking Dead (comic book)

text: Kirkman was a fan of zombie films such as the "Living Dead" series and "Zombi 2" as well as zombie video games such as "Resident Evil". The original pitch by Kirkman and Moore was for a followup to George A. Romero's "Night of the Living Dead", with the series taking place in the 1960s. Image Comics co-founder Jim Valentino suggested using an original concept instead so the creators would own the property outright. The pitch was revised into an original story, taking a more traditional approach to a modern zombie survival tale. The revised pitch was again rejected, however, for being too "normal". Kirkman then pitched it again with a new added twist that the plague was sent by aliens, and that the comic would be more of an alien invasion story. Kirkman had no intention of making the comic about aliens, but felt that the lie was necessary to get the comic published, which it did.


title: The Walking Dead (comic book)

text: "The Walking Dead" debuted in 2003, published by Image Comics, with art by Tony Moore for the first six issues and Cliff Rathburn shading the art after issue #5. Charlie Adlard took over as artist on issue #7, after he was approached by Kirkman. Moore also created the cover art for the first 24 issues and the first four trade paperbacks. The remainder were done by Adlard. Most issues of the comic featured "Letter Hacks", several pages at the end where Kirkman discussed the issue, oftentimes answering letters, mail, and emails sent by readers of the comic. Kirkman usually co-wrote the section with his editor, Sean Mackiewicz.


title: The Walking Dead (comic book)

text: When the television series premiered in October 2010, Image Comics announced "The Walking Dead Weekly". The first 52 issues of the series began to be reprinted on January 5, 2011, with one issue per week for a year. The series is periodically re-published in trade paperbacks which contain six issues each, hardcover books with twelve issues and occasional bonus material, omnibus editions of twenty-four issues, and compendium editions of forty-eight issues.


title: The Walking Dead (comic book)

text: In May 2018, Image Comics and its imprint Skybound Entertainment, the company that has driven development of "The Walking Dead" comic series since 2010, jointly announced "The Walking Dead Day". The fan-oriented event was for October 13, 2018 and coincided with the release of a "Walking Dead" #1 "15th Anniversary Variant Edition", with cover art by Charlie Adlard. A select number of "The Walking Dead Day" participating local comic shops became part of the comic's story line, with their own special edition of Adlard's anniversary cover, featuring the store's logo incorporated into the cover art. The company also noted that additional limited edition collectibles and festivities would be announced at a future date, prior to the October 2018 event.


title: The Walking Dead (comic book)

text: On July 3, 2019, Kirkman confirmed through the "Letter Hacks" section of Issue #193 that the issue had concluded the series, with no previous announcements or warnings beforehand. Kirkman opted to end the comic on his own terms; he stated in his letter in issue #193 that part of the reason to end was that he feared he lacked material to continue the series for several more issues. He had envisioned the series to end around the time that Rick Grimes and his allies reach the Commonwealth, a large human community protected from the walkers, as this would allow him to give a complete arc. However, he found he got there too soon in terms of issues, with the Commonwealth first appearing around issue #150, and Kirkman feared there was no way he could get to an issue #300 with what ideas he had left.