The Berkeley Barb was a weekly underground newspaper published in Berkeley, California , during the years 1965 to 1980. It was one of the first and most influential of the counterculture newspapers, covering such subjects as the anti-war movement and Civil Rights Movement , as well as the social changes advocated by youth culture .
77-683: The newspaper was founded in August 1965 by Max Scherr , a middle-aged radical who had earlier been the owner of the Steppenwolf bar in Berkeley. Scherr was the editor and publisher from the newspaper's inception until the mid-1970s. The Barb carried a great deal of political news, mainly concerning opposition to the Vietnam War and activist political events surrounding the University of California , particularly
154-720: A medical practitioner 's supervision like ibuprofen . In 2014, the FDA added an Ebola treatment being developed by Canadian pharmaceutical company Tekmira to the Fast Track program , but halted the phase 1 trials in July pending the receipt of more information about how the drug works. This was widely viewed as increasingly important in the face of a major outbreak of the disease in West Africa that began in late March 2014 and ended in June 2016. During
231-460: A "FDA Compliant" or "FDA Acceptable". Medical countermeasures (MCMs) are products such as biologics and pharmaceutical drugs that can protect from or treat the health effects of a chemical, biological, radiological, or nuclear (CBRN) attack. MCMs can also be used for prevention and diagnosis of symptoms associated with CBRN attacks or threats. The FDA runs a program called the "FDA Medical Countermeasures Initiative" (MCMi), with programs funded by
308-775: A (fictional) psychoactive substance which, when smoked, supposedly induced a psychedelic high similar to opium and psilocybin. The Barb may have been inspired by Donovan 's 1966 song " Mellow Yellow ", with its lyric "Electrical banana/Is gonna be a sudden craze". The hoax was believed and spread through the mainstream press, and was perpetuated after William Powell included it in The Anarchist Cookbook . A New York Times article on illicit drugs by Donald Louria, MD, noted in passing, that "banana scrapings, provide— if anything—a mild psychedelic experience". The Food and Drug Administration (FDA) investigated and concluded that banana skins were not psychedelic. The Barb
385-425: A REMS program called iPLEDGE . Generic drugs are chemical and therapeutic equivalents of name-brand drugs, normally whose patents have expired. Approved generic drugs should have the same dosage, safety, effectiveness, strength, stability, and quality, as well as route of administration. In general, they are less expensive than their name brand counterparts, are manufactured and marketed by rival companies and, in
462-745: A case. The FDA has a number of field offices across the United States, in addition to international locations in China, India, Europe, the Middle East, and Latin America. As of 2021, the FDA had responsibility for overseeing $ 2.7 trillion in food, medical, and tobacco products. Some 54% of its budget derives from the federal government, and 46% is covered by industry user fees for FDA services. For example, pharmaceutical firms pay fees to expedite drug reviews. According to Forbes, pharmaceutical firms provide 75% of
539-513: A company may advertise or promote a drug only for the specific indication or medical use for which it was approved by FDA. Also, an advertisement must contain a "fair balance" between the benefits and the risks (side effects) of a drug. The regulation of drug advertising in the U.S. is divided between the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC), based on whether
616-426: A complaint brought against the FDA by Mylan Laboratories Inc. of Pittsburgh . When its application to manufacture generics were subjected to repeated delays by the FDA, Mylan, convinced that it was being discriminated against, soon began its own private investigation of the agency in 1987. Mylan eventually filed suit against two former FDA employees and four drug-manufacturing companies, charging that corruption within
693-432: A long period of time. The studies are progressively longer, gradually adding more individuals as they progress from stage I to stage III, normally over a period of years, and normally involve drug companies, the government and its laboratories, and often medical schools and hospitals and clinics. However, any exceptions to the aforementioned process are subject to strict review and scrutiny and conditions, and are only given if
770-555: A new master plan for this expansion in December 2018, and construction is expected to be completed by 2035, dependent on GSA appropriations. The Office of Regulatory Affairs is considered the agency's "eyes and ears", conducting the vast majority of the FDA's work in the field. Its employees, known as Consumer Safety Officers, or more commonly known simply as investigators, inspect production, warehousing facilities, investigate complaints, illnesses, or outbreaks, and review documentation in
847-584: A new staff. The Red Mountain Tribe retaliated by starting their own competing paper, the Berkeley Tribe , which lasted until 1972. The Barb continued to decline. In 1978, with sales down to 20,000 copies (from a peak of over 100,000), in an effort to attract mainstream advertisers, the paper's lucrative sex ads were spun off into a separate publication, the Spectator . The decline continued, and by 1980 circulation of
SECTION 10
#1732855266119924-647: A number of Resident Posts, which are FDA remote offices that serve a particular geographic area. ORA also includes the Agency's network of regulatory laboratories, which analyze any physical samples taken. Though samples are usually food-related, some laboratories are equipped to analyze drugs, cosmetics, and radiation-emitting devices. The Office of Criminal Investigations was established in 1991 to investigate criminal cases. To do so, OCI employs approximately 200 Special Agents nationwide who, unlike ORA Investigators, are armed, have badges, and do not focus on technical aspects of
1001-496: A proposed spin-off sex paper, and when male staffers at Good Times tried to put out a special "Sex" issue, women staffers stole the mock-ups and page layouts and burned them. In 1969, under pressure from an underpaid and rebellious staff which believed, based primarily on information from an accountant, that Scherr was making windfall profits (the Barb may have been the only underground newspaper of which this could be said), Scherr sold
1078-443: A publisher of legal textbooks, hanging out after work at a coffee shop called Il Piccolo Espresso , where he kibbitzed with local bohemians and radicals. By the end of the 1950s "The Pic" had become an important meeting place for SLATE , the progressive student party at U.C. Berkeley . In 1958, Scherr purchased a local hangout popular with students and beatniks called the Steppenwolf at 2136 San Pablo Avenue, Berkeley, which became
1155-494: A role in monitoring safety through influence on ingredients, but they lack legal authority. According to the ACSH, it has reviewed about 1,200 ingredients and has suggested that several hundred be restricted—but there is no standard or systemic method for reviewing chemicals for safety, or a clear definition of what 'safety' even means so that all chemicals get tested on the same basis. However, on December 29, 2022, President Biden signed
1232-523: A satisfied requirement. The FDA does not approve applied coatings used in the food processing industry . There is no review process to approve the composition of nonstick coatings; nor does the FDA inspect or test these materials. Through their governing of processes, however, the FDA does have a set of regulations that cover the formulation, manufacturing, and use of nonstick coatings. Hence, materials like Polytetrafluoroethylene (Teflon) are not and cannot be considered as FDA Approved, but rather, they are
1309-512: A stop on the West Coast folk music circuit. Scherr ran the Steppenwolf for seven years, selling it in 1965 for $ 10,000, which he used to launch the Barb . The first issue of the Barb was dated August 13, 1965. Two thousand copies were printed and sold. According to legend, Scherr started the paper after a projected local paper to be published by the Berkeley food co-op failed to appear. Scoffing at
1386-440: A substantial amount of research and at least some preliminary human testing has shown that they are believed to be somewhat safe and possibly effective. (See FDA Special Protocol Assessment about Phase III trials.) The FDA's Office of Prescription Drug Promotion (OPDP) has responsibilities that revolve around the review and regulation of prescription drug advertising and promotion. This is achieved through surveillance activities and
1463-599: A tailor, and Minnie, were Yiddish -speaking Russian immigrants who arrived in America in 1898. His early life is obscure. From 1935 to 1938, he attended law school at the University of Maryland , earning his law degree in June, 1938. For the next three years he practiced law in Baltimore , including serving as legal counsel to Local 175 of the CIO-affiliated Transport Workers Union in a 1941 Baltimore taxi drivers strike. During World War II he served in
1540-470: A vicious circle of decline. In 1978, with circulation down to 20,000 copies and dropping, the numerous sex ads were spun off into a separate publication, Spectator Magazine . Freed of the stigma of "adults only" but deprived of advertising income, the Barb went out of business within a year and a half. The final issue was dated July 3, 1980. Spectator Magazine ceased publication in October 2005. The Barb
1617-553: A warning to that effect. According to the industry advocacy group, the American Council on Science and Health , though the cosmetic industry is primarily responsible for its own product safety, the FDA can intervene when necessary to protect the public. In general, though, cosmetics do not require pre-market approval or testing. The ACSH says that companies must place a warning note on their products if they have not been tested, and that experts in cosmetic ingredient review also play
SECTION 20
#17328552661191694-401: Is a center of the FDA that regulates food additives and drugs that are given to animals. CVM regulates animal drugs, animal food including pet animal, and animal medical devices. The FDA's requirements to prevent the spread of bovine spongiform encephalopathy are also administered by CVM through inspections of feed manufacturers. CVM does not regulate vaccines for animals; these are handled by
1771-651: Is a separate process, and the drug must be approved through an NDA first. A drug that is approved is said to be "safe and effective when used as directed". Very rare, limited exceptions to this multi-step process involving animal testing and controlled clinical trials can be granted out of compassionate use protocols. This was the case during the 2015 Ebola epidemic with the use, by prescription and authorization, of ZMapp and other experimental treatments, and for new drugs that can be used to treat debilitating and/or very rare conditions for which no existing remedies or drugs are satisfactory, or where there has not been an advance in
1848-547: Is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C). However, the agency also enforces other laws, notably Section 361 of the Public Health Service Act as well as associated regulations. Much of this regulatory-enforcement work is not directly related to food or drugs but involves other factors like regulating lasers , cellular phones , and condoms . In addition, the FDA takes control of diseases in
1925-713: Is located in the White Oak area of Silver Spring, Maryland . The agency has 223 field offices and 13 laboratories located across the 50 states, the United States Virgin Islands , and Puerto Rico . In 2008, the FDA began to post employees to foreign countries, including China, India, Costa Rica, Chile, Belgium, and the United Kingdom. FDA headquarters facilities are currently located in Montgomery County and Prince George's County , Maryland. Since 1990,
2002-449: Is the branch of the FDA responsible for ensuring the safety and efficacy of biological therapeutic agents. These include blood and blood products, vaccines, allergenics, cell and tissue-based products, and gene therapy products. New biologics are required to go through a premarket approval process called a Biologics License Application (BLA), similar to that for drugs. The original authority for government regulation of biological products
2079-737: Is the branch of the FDA responsible for the premarket approval of all medical devices , as well as overseeing the manufacturing, performance and safety of these devices. The definition of a medical device is given in the FD&;C Act, and it includes products from the simple toothbrush to complex devices such as implantable neurostimulators . CDRH also oversees the safety performance of non-medical devices that emit certain types of electromagnetic radiation . Examples of CDRH-regulated devices include cellular phones , airport baggage screening equipment , television receivers , microwave ovens , tanning booths , and laser products . CDRH regulatory powers include
2156-696: Is used for a different purpose, or undergoes any substantial change. The most rigorous requirements apply to new molecular entities : drugs that are not based on existing medications. New drugs receive extensive scrutiny before FDA approval in a process called a new drug application (NDA). Under the Presidency of Donald Trump , the agency has worked to make the drug-approval process go faster. Critics, however, argue that FDA standards are not sufficiently rigorous to prevent unsafe or ineffective drugs from getting approval. New drugs are available only by prescription by default. A change to over-the-counter (OTC) status
2233-451: Is voluntary. While this remains the primary tool of post-market safety surveillance , FDA requirements for post-marketing risk management are increasing. As a condition of approval, a sponsor may be required to conduct additional clinical trials , called Phase IV trials. In some cases, the FDA requires risk management plans called Risk Evaluation and Mitigation Strategies (REMS) for some drugs that require actions to be taken to ensure that
2310-550: The Berkeley Tribe , which soon claimed a circulation of 53,000 copies. Meanwhile, Scherr, who had locked the doors and then taken the files and equipment out of his own offices, continued publishing the Barb out of new offices with a new staff. The paper continued to be successful for a few years but the heyday of the underground press was passing. The Barb was caught up in the general downward trend, with contributor burnout and slowly falling circulation and ad revenues leading to
2387-423: The Barb was down to the same 2000 copies Scherr had started with in 1965. The Barb finally folded in July, 1980. Max Scherr died on October 31, 1981, of cancer. Shortly before his death he told fellow underground newspaper editor Abe Peck: "We were a lot of well-meaning fools. All of us were tainted by the environment we were brought up in. We had no revolutionary base, no real class consciousness. Along with
Berkeley Barb - Misplaced Pages Continue
2464-671: The Center for Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH), the Center for Biologics Evaluation and Research (CBER) and offices for the Center for Veterinary Medicine (CVM). With the passing of the FDA Reauthorization Act of 2017, the FDA projects a 64% increase in employees to 18,000 over the next 15 years and wants to add approximately 1,600,000 square feet (150,000 square metres) of office and special use space to their existing facilities. The National Capital Planning Commission approved
2541-694: The Vietnam Day Committee and the Free Speech Movement . It also served as a venue for music advertisements. Starting around 1967, the Barb was the first underground paper to have an extensive classified ad section carrying explicit personal sex advertisements. Ultimately about a third of the paper was occupied by various forms of sexual advertising: as well as the personals there were ads for X-rated films, pornographic bookstores, mail order novelties and classifieds for models and massage, all both gay and straight. Photos of nude models spilled over into
2618-639: The coronavirus pandemic , FDA granted emergency use authorization for personal protective equipment (PPE), in vitro diagnostic equipment, ventilators and other medical devices. On March 18, 2020, FDA inspectors postponed most foreign facility inspections and all domestic routine surveillance facility inspections. In contrast, the USDA's Food Safety and Inspection Service (FSIS) continued inspections of meatpacking plants, which resulted in 145 FSIS field employees who tested positive for COVID-19, and three who died. The Center for Biologics Evaluation and Research
2695-606: The '2023 Consolidated Budget Act', which includes the 'Cosmetics Regulatory Modernization Act of 2022 (MoCRA)', which is a stricter regulation that is different from the previous regulations. MoCRA requires compliance with matters such as serious adverse event reporting, safety substantiation, additional labeling, record keeping, and Good Manufacturing Practices (GMP). MoCRA also calls on the FDA to grant Mandatory Recall Authority and establish regulations for GMP rules, flavor allergen labeling rules, and testing methods for cosmetics containing talc. The Center for Veterinary Medicine (CVM)
2772-406: The 1990s, accounted for about a third of all prescriptions written in the United States. For a pharmaceutical company to gain approval to produce a generic drug, the FDA requires scientific evidence that the generic drug is interchangeable with or therapeutically equivalent to the originally approved drug. This is called an Abbreviated New Drug Application (ANDA). 80% of prescription drugs sold in
2849-501: 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
2926-622: The FDA exercises differ from one category to the next. Furthermore, legislation had granted the FDA a variety of means to address violations of standards for a given substance category. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the FDA is responsible for ensuring that manufacturers and distributors of dietary supplements and dietary ingredients meet the current requirements. These manufacturers and distributors are not allowed to advertise their products in an adulterated way, and they are responsible for evaluating
3003-687: The FDA has had employees and facilities on 130 acres (53 hectares) of the White Oak Federal Research Center in the White Oak area of Silver Spring, Maryland . In 2001, the General Services Administration (GSA) began new construction on the campus to consolidate the FDA's 25 existing operations in the Washington metropolitan area , its headquarters in Rockville , and several fragmented office buildings. The first building,
3080-703: The FDA released a statement regarding new guidelines to help food and drug manufacturers "implement protections against potential attacks on the U.S. food supply". One of the guidelines includes the Intentional Adulteration (IA) rule, which requires strategies and procedures by the food industry to reduce the risk of compromise in facilities and processes that are significantly vulnerable. The FDA also uses tactics of regulatory shaming, mainly through online publication of non-compliance, warning letters, and "shaming lists." Regulation by shaming harnesses firms' sensitivity to reputational damage. For example, in 2018,
3157-581: The FDA's drug review budget Emergency Use Authorization (EUA) is a mechanism that was created to facilitate the availability and use of medical countermeasures, including vaccines and personal protective equipment, during public health emergencies such as the Zika virus epidemic, the Ebola virus epidemic and the COVID-19 pandemic. The programs for safety regulation vary widely by the type of product, its potential risks, and
Berkeley Barb - Misplaced Pages Continue
3234-871: The Food and Drug Administration is governed by various statutes enacted by the United States Congress and interpreted by the FDA. Pursuant to the Federal Food, Drug, and Cosmetic Act and accompanying legislation, the FDA has authority to oversee the quality of substances sold as food in the United States, and to monitor claims made in the labeling of both the composition and the health benefits of foods. The FDA subdivides substances that it regulates as food into various categories—including foods, food additives , added substances (human-made substances that are not intentionally introduced into food, but nevertheless end up in it), and dietary supplements . Dietary supplements or dietary ingredients include vitamins, minerals, herbs, amino acids , and enzymes . Specific standards
3311-623: The Life Sciences Laboratory, was dedicated and opened with 104 employees in December 2003. As of December 2018, the FDA campus has a population of 10,987 employees housed in approximately 3,800,000 square feet (350,000 square metres) of space, divided into ten offices and four laboratory buildings. The campus houses the Office of the Commissioner (OC), the Office of Regulatory Affairs (ORA),
3388-527: The Navy. After demobilization he attended the University of California, Berkeley , earning a master's degree in sociology in 1949. On a trip to Mexico in the 1940s he met and married Juana Estela Salgado, a medical student. Together, they had a daughter, Raquel Lorraine Scherr, born in 1947, and two sons, Sergio and David Scherr. Returning to California , they lived in Albany , and Berkeley , where Max Scherr worked for
3465-477: The United States are generic brands. In 1989, a major scandal erupted involving the procedures used by the FDA to approve generic drugs for sale to the public. Charges of corruption in generic drug approval first emerged in 1988 during the course of an extensive congressional investigation into the FDA. The oversight subcommittee of the United States House Energy and Commerce Committee resulted from
3542-809: The agency published an online "black list", in which it named dozens of branded drug companies that are supposedly using unlawful or unethical means to attempt to impede competition from generic drug companies. The FDA frequently works with other federal agencies, including the Department of Agriculture , the Drug Enforcement Administration , Customs and Border Protection , and the Consumer Product Safety Commission . They also often work with local and state government agencies in performing regulatory inspections and enforcement actions. The regulation of food and dietary supplements by
3619-468: The authority to require certain technical reports from the manufacturers or importers of regulated products, to require that radiation-emitting products meet mandatory safety performance standards, to declare regulated products defective, and to order the recall of defective or noncompliant products. CDRH also conducts limited amounts of direct product testing. Clearance requests are required for medical devices that prove they are "substantially equivalent" to
3696-473: The case of medical devices, drugs, biological products, and other items where it may be difficult to conduct a physical examination or take a physical sample of the product. The Office of Regulatory Affairs is divided into five regions, which are further divided into 20 districts. The districts are based roughly on the geographic divisions of the Federal court system . Each district comprises a main district office and
3773-469: The city was occupied by the National Guard, left many in Berkeley with little appetite for further confrontation. The paper grew rapidly, developing a nationwide following, and by mid-1969 Time reported that the paper was circulating 86,000 copies and charging $ 450 a page for advertising, turning an annual profit of $ 150,000. This led to conflict with the paper's staff of 40, which was earning at most
3850-437: The claim that it would cost $ 43,000 to launch a small local paper in Berkeley, he boasted that he would have the first issue out in a week. Around 1960 Scherr had split from Juana Estela Salgado and moved in with a much younger woman named Jane Peters (born Beatrice J. Peters in 1937), with whom he had two daughters, Dove and Apollinaire. By 1965 they had moved into a large, colonnaded house at 2421 Oregon Street. Coming home from
3927-502: The contexts varying from household pets to human sperm donated for use in assisted reproduction . The FDA is led by the commissioner of Food and Drugs , appointed by the President with the advice and consent of the Senate . The commissioner reports to the secretary of health and human services . Robert Califf is the current commissioner as of February 17, 2022. The FDA's headquarters
SECTION 50
#17328552661194004-404: The control and supervision of food safety , tobacco products, caffeine products, dietary supplements , prescription and over-the-counter pharmaceutical drugs (medications), vaccines , biopharmaceuticals , blood transfusions , medical devices , electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products . The FDA's primary focus
4081-466: The drug in question is a prescription drug or an over-the-counter (OTC) drug. The FDA oversees the advertising of prescription drugs, while the FTC regulates the advertising of OTC drugs. The term off-label refers to the practice of prescribing a drug for a different purpose than what the FDA approved. Due to this approval requirement, manufacturers were prohibited from advertising COVID-19 vaccines during
4158-416: The drug is used safely. For example, thalidomide can cause birth defects, but has uses that outweigh the risks if men and women taking the drugs do not conceive a child; a REMS program for thalidomide mandates an auditable process to ensure that people taking the drug take action to avoid pregnancy; many opioid drugs have REMS programs to avoid addiction and diversion of drugs. The drug isotretinoin has
4235-678: The early 1990s, the U.S. Securities and Exchange Commission filed securities fraud charges against the Bolar Pharmaceutical Company, a major generic manufacturer based in Long Island, New York. Over-the-counter (OTC) are drugs like aspirin that do not require a doctor's prescription. The FDA has a list of approximately 800 such approved ingredients that are combined in various ways to create more than 100,000 OTC drug products. Many OTC drug ingredients had been previously approved prescription drugs now deemed safe enough for use without
4312-648: The federal agency resulted in racketeering and in violations of antitrust law . "The order in which new generic drugs were approved was set by the FDA employees even before drug manufacturers submitted applications" and, according to Mylan, this illegal procedure was followed to give preferential treatment to certain companies. During the summer of 1989, three FDA officials (Charles Y. Chang, David J. Brancato, Walter Kletch) pleaded guilty to criminal charges of accepting bribes from generic drugs makers, and two companies ( Par Pharmaceutical and its subsidiary Quad Pharmaceuticals) pleaded guilty to giving bribes. Furthermore, it
4389-436: The federal government. It helps support "partner" agencies and organisations prepare for public health emergencies that could require MCMs. The Center for Drug Evaluation and Research uses different requirements for the three main drug product types: new drugs, generic drugs, and over-the-counter drugs. A drug is considered "new" if it is made by a different manufacturer, uses different excipients or inactive ingredients,
4466-433: The food co-op, he informed Peters that they had to put a paper out in one week "or I'll be the laughingstock of Berkeley." At the end of the week the promised paper, mostly written by Scherr, appeared. The smudgy first issue of 8 tabloid pages was crudely printed in a small edition of 2000 copies, and the paper was launched on a run which lasted almost 15 years. The Barb quickly became the news and communications center for
4543-459: The good, we developed a large rip-off philosophy." But, he added, "we broke down a lot of barriers to honest thought and opened up a whole visionary realm of the future, which has to be worked on." Food and Drug Administration The United States Food and Drug Administration ( FDA or US FDA ) is a federal agency of the Department of Health and Human Services . The FDA is responsible for protecting and promoting public health through
4620-545: The issuance of enforcement letters to pharmaceutical manufacturers. Advertising and promotion for over-the-counter drugs is regulated by the Federal Trade Commission . The FDA also implements regulatory oversight through engagement with third-party enforcer-firms. It expects pharmaceutical companies to ensure that third-party suppliers and labs comply with the agency's health and safety guidelines . The drug advertising regulation contains two broad requirements: (1)
4697-461: The legal minimum wage, and the staff rebelled, forming the Red Mountain Tribe collective and issuing a special interim edition called Barb on Strike without Scherr, who managed to put out a bare-bones 8-page issue of the paper on schedule without assistance. Scherr succeeded in getting the Tribe out of the paper's offices, whereupon he moved the newspaper's equipment into a new office and hired
SECTION 60
#17328552661194774-569: The militant New Left protest movements swirling around the Berkeley campus of the University of California, where the Free Speech Movement made nationwide headlines in 1964. By the fall of 1965 antiwar protest led by the Vietnam Day Committee and Jerry Rubin dominated campus activism in Berkeley, and the Barb soon emerged as the unofficial mouthpiece of the VDC. In the San Francisco Bay Area
4851-533: The news section. The formula of radical politics and sex worked, and the Barb was one of the top-selling underground papers in the nation. Efforts to clone this formula in other cities (e.g. Rat in New York City) ran into resistance from staff, readers and local authorities; female staffers and supporters from the Berkeley Tribe staged a sit-in at San Francisco's Dock of the Bay to successfully block publication of
4928-445: The paper for $ 200,000 to Allan Coult, a professor of anthropology. The deal fell apart shortly afterwards and Scherr resumed ownership, cancelling the agreement after Coult failed to make the initial payment. At this point almost all of the 40 person staff, including managing editor James A. Schreiber, walked out and formed the "Red Mountain Tribe". After putting out a special Barb on Strike issue, they launched their own rival newspaper,
5005-456: The paper provided a radical alternative to the stodgy conservatism and anticommunism of the established local press, dominated by Hearst's San Francisco Examiner , the Chronicle and William Knowland 's Oakland Tribune . Max Scherr considered himself and the paper to be part of the revolutionary left, although he had never been in any organized left-wing party, and the paper's news coverage
5082-578: The paper reporting that all the Buddhist kids in Japan were converting to Judaism". Scherr ran the letter. Max Scherr Max Scherr (March 12, 1916 – October 31, 1981) was an American underground newspaper editor and publisher known for his iconoclastic 1960s weekly, the Berkeley Barb . Scherr was born in Baltimore, Maryland , on March 12, 1916, in a Jewish household. His parents, Harry Scherr,
5159-533: The period in which they had only been approved under Emergency Use Authorization . After NDA approval, the sponsor must then review and report to the FDA every single patient adverse drug experience it learns of. They must report unexpected serious and fatal adverse drug events within 15 days, and other events on a quarterly basis. The FDA also receives directly adverse drug event reports through its MedWatch program. These reports are called "spontaneous reports" because reporting by consumers and health professionals
5236-422: The predicate devices already on the market. Approved requests are for items that are new or substantially different and need to demonstrate "safety and efficacy", for example they may be inspected for safety in case of new toxic hazards. Both aspects need to be proved or provided by the submitter to ensure proper procedures are followed. Cosmetics are regulated by the Center for Food Safety and Applied Nutrition ,
5313-566: 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
5390-470: The regulatory powers granted to the agency. For example, the FDA regulates almost every facet of prescription drugs, including testing, manufacturing, labeling, advertising, marketing, efficacy, and safety—yet FDA regulation of cosmetics focuses primarily on labeling and safety. The FDA regulates most products with a set of published standards enforced by a modest number of facility inspections. Inspection observations are documented on Form 483 . In June 2018,
5467-448: The safety and labeling of their product. The FDA has a "Dietary Supplement Ingredient Advisory List" that includes ingredients that sometimes appear on dietary supplements but need further evaluation. An ingredient is added to this list when it is excluded from use in a dietary supplement, does not appear to be an approved food additive or recognized as safe, and/or is subjected to the requirement for pre-market notification without having
5544-458: The same branch of the FDA that regulates food. Cosmetic products are not, in general, subject to premarket approval by the FDA unless they make "structure or function claims" that make them into drugs (see Cosmeceutical ). However, all color additives must be specifically FDA approved before manufacturers can include them in cosmetic products sold in the U.S. The FDA regulates cosmetics labeling, and cosmetics that have not been safety tested must bear
5621-533: Was discovered that several manufacturers had falsified data submitted in seeking FDA authorization to market certain generic drugs. Vitarine Pharmaceuticals of New York, which sought approval of a generic version of the drug Dyazide , a medication for high blood pressure, submitted Dyazide, rather than its generic version, for the FDA tests. In April 1989, the FDA investigated 11 manufacturers for irregularities; and later brought that number up to 13. Dozens of drugs were eventually suspended or recalled by manufacturers. In
5698-534: Was established by the 1902 Biologics Control Act , with additional authority established by the 1944 Public Health Service Act . Along with these Acts, the Federal Food, Drug, and Cosmetic Act applies to all biologic products, as well. Originally, the entity responsible for regulation of biological products resided under the National Institutes of Health ; this authority was transferred to the FDA in 1972. The Center for Devices and Radiological Health (CDRH)
5775-574: Was itself subjected to hoaxes. At a memorial for the social activist and founder of the Yippies , Stew Albert , the following story was told: One victim of an Albert prank was Max Scherr, editor of the Berkeley Barb , that legendary paper of the days of the Movement. "A lot of Jewish kids were converting to Buddhism then", Paul Glusman said, "so Albert cooked up a hoax, getting a letter mailed from Japan to
5852-420: Was often seen as baiting the police and authorities in Berkeley, with inflammatory headlines like "Pigs Shoot to Kill—Bystanders Gunned Down." The battle over People's Park which began in 1969 with an article by Stew Albert in the Barb was in some respects the paper's high-water mark in arousing its readers to militant activism in the streets, but the bitter aftermath, in which several protestors were shot and
5929-452: Was one of the first papers to print underground comix , featuring Joel Beck 's Lenny of Laredo in 1965; and later featuring the work of cartoonists such as Dave Sheridan and Bill Griffith (" Zippy the Pinhead " beginning in 1976). In March 1967, Scherr, hoping to trick authorities into banning bananas, ran a satirical story which claimed that dried banana skins contained " bananadine ",
#118881