The Memphis Flyer is a free weekly alternative newspaper serving the greater Memphis, Tennessee , area. The Flyer covers Memphis news, politics, music, entertainment, sports, food, and spirits.
118-423: The Flyer was founded February 14, 1989 by Kenneth Neill. The current editor is Shara Clark. She was preceded in the role by Jesse Davis, who took over for Bruce VanWyngarden, the editor of the flyer from 2001-2021, on May 12, 2021. The Flyer is a publication of Contemporary Media, Inc. which also publishes Memphis Magazine , Memphis Parent , and Inside Memphis Business . The current CEO of Contemporary Media
236-743: A medical practitioner 's supervision like ibuprofen . In 2014, the FDA added an Ebola treatment being developed by Canadian pharmaceutical company Tekmira to the Fast Track program , but halted the phase 1 trials in July pending the receipt of more information about how the drug works. This was widely viewed as increasingly important in the face of a major outbreak of the disease in West Africa that began in late March 2014 and ended in June 2016. During
354-460: 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
472-511: A 2003 interview, VanWyngarden stated that the Flyer began refusing ads from anyone who was not a "legally licensed business" by the mid 1990s. In October 2019, Kroger stores stopped allowing free newspapers and magazines to be distributed via their stores. Nationwide, they removed the racks and informed the publications of the change. The Flyer reported at the time that they moved 9,000 papers weekly through Kroger stores alone. During COVID-19 ,
590-425: 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
708-767: A case. The FDA has a number of field offices across the United States, in addition to international locations in China, India, Europe, the Middle East, and Latin America. As of 2021, the FDA had responsibility for overseeing $ 2.7 trillion in food, medical, and tobacco products. Some 54% of its budget derives from the federal government, and 46% is covered by industry user fees for FDA services. For example, pharmaceutical firms pay fees to expedite drug reviews. According to Forbes, pharmaceutical firms provide 75% of
826-430: A coloring book campaign. The proceeds were split equally between the contributing artists and the Flyer . The initiative was popular enough to be continued in 2021, but it does not appear to have carried forward. The Flyer's website, Memphisflyer.com, features daily posts of local news, politics, music, food, and entertainment. Content from the Flyer' s weekly print edition is posted on Thursday morning. Back issues for
944-527: A company may advertise or promote a drug only for the specific indication or medical use for which it was approved by FDA. Also, an advertisement must contain a "fair balance" between the benefits and the risks (side effects) of a drug. The regulation of drug advertising in the U.S. is divided between the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC), based on whether
1062-426: 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
1180-574: A letter asking the federal government to "shut it down now, and start over". In July and early August, requests multiplied, with a number of experts asking for lockdowns of "six to eight weeks" that they believed would restore the country by October 1, in time to reopen schools and have an in-person election. In August, over 400,000 people attended the 80th Sturgis Motorcycle Rally in Sturgis, South Dakota , and from there, at least 300 people in more than 20 states were infected. The CDC followed up with
1298-432: 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
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#17327823215001416-560: A new master plan for this expansion in December 2018, and construction is expected to be completed by 2035, dependent on GSA appropriations. The Office of Regulatory Affairs is considered the agency's "eyes and ears", conducting the vast majority of the FDA's work in the field. Its employees, known as Consumer Safety Officers, or more commonly known simply as investigators, inspect production, warehousing facilities, investigate complaints, illnesses, or outbreaks, and review documentation in
1534-651: A number of Resident Posts, which are FDA remote offices that serve a particular geographic area. ORA also includes the Agency's network of regulatory laboratories, which analyze any physical samples taken. Though samples are usually food-related, some laboratories are equipped to analyze drugs, cosmetics, and radiation-emitting devices. The Office of Criminal Investigations was established in 1991 to investigate criminal cases. To do so, OCI employs approximately 200 Special Agents nationwide who, unlike ORA Investigators, are armed, have badges, and do not focus on technical aspects of
1652-554: A report on the associated 51 confirmed primary event-associated cases, 21 secondary cases, and five tertiary cases in the neighboring state of Minnesota, where one attendee died of COVID-19. The U.S. passed five million COVID-19 cases by August 8. On September 22, the U.S. passed 200,000 deaths, according to data from Johns Hopkins University. In early October, an unprecedented series of high-profile U.S. political figures and staffers announced they had tested positive for COVID-19. On October 2, Trump announced on Twitter that both he and
1770-498: A role in monitoring safety through influence on ingredients, but they lack legal authority. According to the ACSH, it has reviewed about 1,200 ingredients and has suggested that several hundred be restricted—but there is no standard or systemic method for reviewing chemicals for safety, or a clear definition of what 'safety' even means so that all chemicals get tested on the same basis. However, on December 29, 2022, President Biden signed
1888-523: 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
2006-636: A single day. By the end of 2022, an estimated 77.5% of Americans had had COVID-19 at least once, according to the CDC. State and local responses to the pandemic during the public health emergency included the requirement to wear a face mask in specified situations (mask mandates), prohibition and cancellation of large-scale gatherings (including festivals and sporting events), stay-at-home orders , and school closures . Disproportionate numbers of cases were observed among Black and Latino populations, as well as elevated levels of vaccine hesitancy, and there
2124-433: A small proportion of overall variants. Although variant XBB was of concern internationally, it was rare in the United States. Recommendations for receiving vaccination booster shots are mixed: while populations at risk of severe disease and death should stay up-to-date, healthy, middle-aged-and-younger populations are rarely at risk of severe illness, and most have adequate immunity. Although the newest bivalent boosters target
2242-440: 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
2360-581: A surge in Beijing caused the Biden administration to require U.S. visitors from China, Hong Kong, and Macau to provide proof of COVID-19 negative test results. At the end of the year, the CDC reported that the COVID Omicron XBB.1.5 variant became much more prevalent and represented about 41% of new cases in the U.S. Scientists at Columbia University warned that the rise of subvariants could "result in
2478-476: A surge of breakthrough infections as well as re-infections." On January 11, 2023, the Biden administration decided to renew the COVID-19 public health emergency amid a winter surge of cases related to highly transmissible Omicron subvariants. With relief measures such as automatic Medicaid re-enrollment being decoupled from the emergency declaration, some commentators believed this signaled the final extension of
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#17327823215002596-545: A third surge of cases began; there were over 200,000 new daily cases during parts of December 2020 and January 2021. COVID-19 vaccines became available in December 2020, under emergency use, beginning the national vaccination program , with the first vaccine officially approved by the Food and Drug Administration (FDA) on August 23, 2021. Studies have shown them to be highly protective against severe illness, hospitalization, and death. In comparison with fully vaccinated people,
2714-561: A warning to that effect. According to the industry advocacy group, the American Council on Science and Health , though the cosmetic industry is primarily responsible for its own product safety, the FDA can intervene when necessary to protect the public. In general, though, cosmetics do not require pre-market approval or testing. The ACSH says that companies must place a warning note on their products if they have not been tested, and that experts in cosmetic ingredient review also play
2832-556: Is Anna Traverse Fogle. The Memphis Flyer is distributed throughout the Mid-South on Wednesday morning. The Flyer touts that they have 600-plus distribution points. (see External Links) The paper touts that it has more than 222,000 regular readers. Exact circulation numbers are unclear. Traditionally, free publications have used advertisements in order to pay for their publications. With alt-weeklies, that often meant running ads from risqué sources, sometimes including paid escorts. In
2950-610: Is a federal agency of the Department of Health and Human Services . The FDA is responsible for protecting and promoting public health through the control and supervision of food safety , tobacco products, caffeine products, dietary supplements , prescription and over-the-counter pharmaceutical drugs (medications), vaccines , biopharmaceuticals , blood transfusions , medical devices , electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products . The FDA's primary focus
3068-401: 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
3186-651: 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
3304-564: Is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C). However, the agency also enforces other laws, notably Section 361 of the Public Health Service Act as well as associated regulations. Much of this regulatory-enforcement work is not directly related to food or drugs but involves other factors like regulating lasers , cellular phones , and condoms . In addition, the FDA takes control of diseases in
3422-745: Is located in the White Oak area of Silver Spring, Maryland . The agency has 223 field offices and 13 laboratories located across the 50 states, the United States Virgin Islands , and Puerto Rico . In 2008, the FDA began to post employees to foreign countries, including China, India, Costa Rica, Chile, Belgium, and the United Kingdom. FDA headquarters facilities are currently located in Montgomery County and Prince George's County , Maryland. Since 1990,
3540-449: 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
3658-741: Is the branch of the FDA responsible for the premarket approval of all medical devices , as well as overseeing the manufacturing, performance and safety of these devices. The definition of a medical device is given in the FD&;C Act, and it includes products from the simple toothbrush to complex devices such as implantable neurostimulators . CDRH also oversees the safety performance of non-medical devices that emit certain types of electromagnetic radiation . Examples of CDRH-regulated devices include cellular phones , airport baggage screening equipment , television receivers , microwave ovens , tanning booths , and laser products . CDRH regulatory powers include
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3776-416: Is three times the fatality rate of a bad flu season . The number of cases for the months of July through September 2022 was about 0.86 times the number for the same period in 2021, and the number of COVID-attributed deaths likewise averaged 0.42 times the number for the same period in 2021. In October, new variants BQ.1 and BQ.1.1 from the dominant BA.5 appeared to be spreading quickly, but comprised only
3894-702: Is used for a different purpose, or undergoes any substantial change. The most rigorous requirements apply to new molecular entities : drugs that are not based on existing medications. New drugs receive extensive scrutiny before FDA approval in a process called a new drug application (NDA). Under the Presidency of Donald Trump , the agency has worked to make the drug-approval process go faster. Critics, however, argue that FDA standards are not sufficiently rigorous to prevent unsafe or ineffective drugs from getting approval. New drugs are available only by prescription by default. A change to over-the-counter (OTC) status
4012-451: 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
4130-511: The Biden administration advised Congress of a lack of funding for testing, therapeutics and vaccines, but Republicans continued to block new spending on the pandemic so Democrats removed an emergency aid package from a proposed spending bill. On March 20, Dr. Anthony S. Fauci warned of an "uptick" in cases like Europe had seen recently, stating the U.S. should "be prepared for the possibility that we might get another variant". In April 2022, it
4248-685: The Center for Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH), the Center for Biologics Evaluation and Research (CBER) and offices for the Center for Veterinary Medicine (CVM). With the passing of the FDA Reauthorization Act of 2017, the FDA projects a 64% increase in employees to 18,000 over the next 15 years and wants to add approximately 1,600,000 square feet (150,000 square metres) of office and special use space to their existing facilities. The National Capital Planning Commission approved
4366-549: The Flyer changed to bi-weekly circulation. "We will print the April 2nd issue of the Flyer. Our next print issue after April 2nd will be April 16th, and we will proceed on a biweekly schedule thereafter. We plan to reevaluate our status and the community’s status in June, and to consider ramping back up to a weekly schedule at that time." While cutting back on its circulation, the paper worked to help keep local artists afloat by creating
4484-691: The National Institute of Allergy and Infectious Diseases Anthony Fauci said the mortality from COVID-19 was ten times higher than the common flu . By March 12, diagnosed cases of COVID-19 in the U.S. exceeded a thousand. Trump declared a national emergency on March 13. On March 16, the White House advised against any gatherings of more than ten people. Three days later, the United States Department of State advised U.S. citizens to avoid all international travel. By
4602-508: The cluster on December 31, 2019. After China confirmed that the cluster of infections was caused by a novel infectious coronavirus on January 7, 2020, the CDC issued an official health advisory the following day. On January 20, the World Health Organization (WHO) and China both confirmed that human-to-human transmission had occurred. The CDC immediately activated its Emergency operations center (EOC) to respond to
4720-643: The coronavirus pandemic , FDA granted emergency use authorization for personal protective equipment (PPE), in vitro diagnostic equipment, ventilators and other medical devices. On March 18, 2020, FDA inspectors postponed most foreign facility inspections and all domestic routine surveillance facility inspections. In contrast, the USDA's Food Safety and Inspection Service (FSIS) continued inspections of meatpacking plants, which resulted in 145 FSIS field employees who tested positive for COVID-19, and three who died. The Center for Biologics Evaluation and Research
4838-606: 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)
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4956-589: The 1 million mark with a presidential proclamation on May 12, ordering flags to be flown at half-staff at all federal facilities through sundown on May 16. In June, the United States concluded the approval process for the vaccination of children under five years of age, with the first vaccines expected to be administered on June 21. On June 12, the U.S. dropped COVID testing requirements for inbound international air travelers, while vaccination requirements largely remained in place for inbound travelers using any mode of cross-border transportation. The number of cases for
5074-406: 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
5192-613: The American public for the first time to prepare for a local outbreak. The next day, New York City saw the sickening of its "patient zero", Manhattan attorney Lawrence Garbuz, then thought to be the first community-acquired case. Another case known as "patient zero" in Los Angeles is a man named Gregg Garfield, who spent 64 days in the Burbank Hospital, on a ventilator for 30 days, with a 1% chance to live. Contracting
5310-507: The Biden administration felt that there was "enough community protection that we're not going to see a repeat of what we saw last year at this time," referring to the emergence of the Omicron variant. A study of vaccine effectiveness found that U.S.-authorized bivalent mRNA boosters administered to those having already received 2 to 4 monovalent vaccinations provided significant additional protection against symptomatic SARS-CoV-2. Concerns of
5428-463: The Biden administration on the advice of the CDC, was ended nationwide by U.S. District Judge Kathryn Kimball Mizelle , a Trump-appointed federal judge in Florida. The Justice Department challenged the ruling several days later, yet masks remained optional on airplanes, buses, and subway systems, except when required by local mandates. The first annual National COVID Week of Remembrance & Action
5546-565: The CDC confirmed the first person-to-person case in the U.S. The next day, the country declared a public health emergency. Although by that date there were only seven known cases in the U.S., the HHS and CDC reported that there was a likelihood of further cases appearing in the country. The Trump administration evacuated American nationals from Wuhan in January. On February 2, the U.S. enacted travel restrictions to and from China. On February 6,
5664-545: The CDC found that those who were unvaccinated were from 5 to nearly 30 times more likely to become either infected or hospitalized. There has nonetheless been some vaccine hesitancy for various reasons, although side effects are rare. There were also numerous reports that unvaccinated COVID-19 patients strained the capacity of hospitals throughout the country , forcing many to turn away patients with life-threatening diseases. A fourth rise in infections began in March 2021 amidst
5782-585: The Delta variant. By July 7, the Delta variant had surpassed the Alpha variant to become the dominant COVID-19 strain in the U.S., according to CDC data. By August the Delta variant accounted for 99 percent of all cases and was found to double the risk of hospitalization for those not yet vaccinated. On August 1, the U.S. passed 35 million cases. By early and mid-August, hospitals in some states with low vaccination rates began to exceed capacity. One-quarter of
5900-511: The FD&C Act. OCI Special Agents often come from other criminal investigations backgrounds, and frequently work closely with the Federal Bureau of Investigation , Assistant Attorney General , and even Interpol . OCI receives cases from a variety of sources—including ORA, local agencies, and the FBI, and works with ORA Investigators to help develop the technical and science-based aspects of
6018-633: The FDA exercises differ from one category to the next. Furthermore, legislation had granted the FDA a variety of means to address violations of standards for a given substance category. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the FDA is responsible for ensuring that manufacturers and distributors of dietary supplements and dietary ingredients meet the current requirements. These manufacturers and distributors are not allowed to advertise their products in an adulterated way, and they are responsible for evaluating
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#17327823215006136-724: The FDA has had employees and facilities on 130 acres (53 hectares) of the White Oak Federal Research Center in the White Oak area of Silver Spring, Maryland . In 2001, the General Services Administration (GSA) began new construction on the campus to consolidate the FDA's 25 existing operations in the Washington metropolitan area , its headquarters in Rockville , and several fragmented office buildings. The first building,
6254-713: The FDA released a statement regarding new guidelines to help food and drug manufacturers "implement protections against potential attacks on the U.S. food supply". One of the guidelines includes the Intentional Adulteration (IA) rule, which requires strategies and procedures by the food industry to reduce the risk of compromise in facilities and processes that are significantly vulnerable. The FDA also uses tactics of regulatory shaming, mainly through online publication of non-compliance, warning letters, and "shaming lists." Regulation by shaming harnesses firms' sensitivity to reputational damage. For example, in 2018,
6372-538: 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
6490-553: The First Lady had tested positive for COVID-19 and would immediately quarantine. Trump was given an experimental Regeneron product with two monoclonal antibodies and taken to Walter Reed National Military Medical Center , where he was given remdesivir and dexamethasone . USA Today studied the aftermath of presidential election campaigning, recognizing that causation was impossible to determine. Among their findings, cases increased 35 percent compared to 14 percent for
6608-881: The Food and Drug Administration is governed by various statutes enacted by the United States Congress and interpreted by the FDA. Pursuant to the Federal Food, Drug, and Cosmetic Act and accompanying legislation, the FDA has authority to oversee the quality of substances sold as food in the United States, and to monitor claims made in the labeling of both the composition and the health benefits of foods. The FDA subdivides substances that it regulates as food into various categories—including foods, food additives , added substances (human-made substances that are not intentionally introduced into food, but nevertheless end up in it), and dietary supplements . Dietary supplements or dietary ingredients include vitamins, minerals, herbs, amino acids , and enzymes . Specific standards
6726-427: The January 2023 distribution, and the 17 other states which terminated pandemic food supplements prior to the federal end date were all states with Republican-controlled state legislatures. On January 31, 2023, President Biden announced the end to the COVID-19 emergency declarations by May 11, 2023. By February 23, eighteen states had already cut payments for more than 10 million people, and Congress had decided to end
6844-647: The Life Sciences Laboratory, was dedicated and opened with 104 employees in December 2003. As of December 2018, the FDA campus has a population of 10,987 employees housed in approximately 3,800,000 square feet (350,000 square metres) of space, divided into ten offices and four laboratory buildings. The campus houses the Office of the Commissioner (OC), the Office of Regulatory Affairs (ORA),
6962-554: The Trump administration reached an agreement with a number of retail outlets, including pharmacies and supermarkets, to make the COVID-19 vaccine free once available. In spite of recommendations by the government not to travel, more than 2 million people flew on airlines during the Thanksgiving period. On December 8, the U.S. passed 15 million cases, with about one out of every 22 Americans having tested positive since
7080-473: The U.S. death toll became the highest in the world when the number of deaths reached 20,000, surpassing that of Italy . On April 19, the CMS added new regulations requiring nursing homes to inform residents, their families and representatives, of COVID-19 cases in their facilities. On April 28, the total number of confirmed cases across the country surpassed 1 million. By May 27, less than four months after
7198-471: The U.S. passed 25 million cases, with one of every 13 Americans testing positive for COVID-19. On January 29, a nationwide requirement for use of face masks on public transit and other forms of public transportation was issued by the CDC and the federal Transportation Security Administration , to go into effect on February 1. (Subsequently, extended, the federal mask mandate for public transportation remains in effect in April 2022.) On February 22,
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#17327823215007316-418: The U.S. passed 30 million cases, just as a number of states began to expand the eligibility age for COVID-19 vaccines. Experts began warning against public relaxation of COVID-19 mitigation measures as vaccines continue to be administered, with CDC director Rochelle Walensky , warning of a new rise in cases. By April 7, the Alpha variant had become the dominant COVID-19 strain in the U.S. On April 12,
7434-498: The U.S. passed 45 million cases. On November 26, Biden announced that the U.S. will restrict travel from South Africa and seven other African countries due to concerns over a new variant from the area , called Omicron. At the beginning of January 2022, the number of cases per day exceeded 1 million. As of February 1, fatality rates were 63% higher in the U.S. than other large wealthy countries, due in part to far lower vaccination rates compared to those countries. On March 9,
7552-443: The U.S. passed 500,000 deaths, just five weeks after the country passed 400,000 deaths. By March 5, more than 2,750 cases of COVID-19 variants were detected in 47 states; Washington, D.C.; and Puerto Rico . In the first prime time address of his presidency, on March 11, Biden announced his plan to push states to make vaccines available to all adults by May 1, with the aim of making small gatherings possible by July 4 . On March 24,
7670-419: The U.S. population had been infected with the virus as of March 2021, about four times higher than the official reported numbers. On May 4, Biden announced a new goal of having 70 percent of all adults in the U.S. receive at least one COVID-19 vaccine shot by July 4, along with steps to vaccinate teenagers and more inaccessible populations. The country ultimately did not reach that goal, with only 67 percent of
7788-580: The U.S. population resides in eight states—Alabama, Arkansas, Florida, Georgia, Louisiana, Mississippi, Nevada, and Texas—but, by mid-August, these states together had a half of COVID-19 hospitalizations in the nation. By the end of the month, the ICUs of five of those—Alabama, Arkansas, Florida, Georgia, and Texas—were over 90% full. On September 8, the U.S. passed 40 million cases. By September 15, one in every 500 Americans had died from COVID-19. By September 20, COVID-19 had killed over 675,000 Americans,
7906-465: The U.S. reported its first cases of a new "double mutant" SARS-CoV-2 variant from India , later called Delta, in California. By April 25, the country's seven-day average of new infections was reported to be decreasing, but concerns were raised about drops in vaccine demand in certain parts of the U.S., which were attributed to vaccine hesitancy . On April 29, the CDC estimated that roughly 35% of
8024-532: The United Kingdom , later called Alpha, the CDC announced testing requirements for American passengers traveling from the UK , to be administered within 72 hours, starting on December 28. On December 29, the U.S. reported the first case of this variant in Colorado. The patient had no travel history, leading the CDC to say, "Given the small fraction of US infections that have been sequenced, the variant could already be in
8142-488: The United States are generic brands. In 1989, a major scandal erupted involving the procedures used by the FDA to approve generic drugs for sale to the public. Charges of corruption in generic drug approval first emerged in 1988 during the course of an extensive congressional investigation into the FDA. The oversight subcommittee of the United States House Energy and Commerce Committee resulted from
8260-408: The United States without having been detected." On January 1, 2021, the U.S. passed 20 million cases, representing an increase of more than a million over the past week and 10 million in less than two months. On January 6, the CDC announced that it had found at least 52 confirmed cases of the Alpha variant, and it also stressed that there could already be more cases in the country. In
8378-784: The agency published an online "black list", in which it named dozens of branded drug companies that are supposedly using unlawful or unethical means to attempt to impede competition from generic drug companies. The FDA frequently works with other federal agencies, including the Department of Agriculture , the Drug Enforcement Administration , Customs and Border Protection , and the Consumer Product Safety Commission . They also often work with local and state government agencies in performing regulatory inspections and enforcement actions. The regulation of food and dietary supplements by
8496-468: 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
8614-695: The bill, the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 , on March 6. Trump declared a national emergency on March 13. The government also purchased large quantities of medical equipment, invoking the Defense Production Act of 1950 to assist. By mid-April, disaster declarations were made by all states and territories as they all had increasing cases. A second wave of infections began in June, following relaxed restrictions in several states, leading to daily cases surpassing 60,000. By mid-October,
8732-478: The case of medical devices, drugs, biological products, and other items where it may be difficult to conduct a physical examination or take a physical sample of the product. The Office of Regulatory Affairs is divided into five regions, which are further divided into 20 districts. The districts are based roughly on the geographic divisions of the Federal court system . Each district comprises a main district office and
8850-511: 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
8968-469: 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
9086-416: 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
9204-540: The earliest confirmed American death with COVID-19 (that of a 57-year-old woman) occurred in Santa Clara County, California . The CDC did not report its confirmation until April 21, by which point nine other COVID-19 deaths had occurred in Santa Clara County. The virus had been circulating undetected at least since early January and possibly as early as November. On February 25, the CDC warned
9322-696: The early 1990s, the U.S. Securities and Exchange Commission filed securities fraud charges against the Bolar Pharmaceutical Company, a major generic manufacturer based in Long Island, New York. Over-the-counter (OTC) are drugs like aspirin that do not require a doctor's prescription. The FDA has a list of approximately 800 such approved ingredients that are combined in various ways to create more than 100,000 OTC drug products. Many OTC drug ingredients had been previously approved prescription drugs now deemed safe enough for use without
9440-691: The emergency declaration. Although some states had already ended emergency SNAP benefits enacted during the pandemic, the USDA announced that emergency allotments for the remaining 32 states, the District of Columbia , Guam , and the U.S. Virgin Islands would end after the February 2023 distribution. Leaders of some anti-hunger organizations believed that the end of the $ 95-per-month additional benefit would strain local food pantries and food banks. South Carolina , which ended emergency food grants after
9558-454: The estimated number of American deaths from the Spanish flu in 1918. As a result, COVID-19 became the deadliest respiratory pandemic in recent American history. The Associated Press called the new numbers a "colossal tragedy" because, despite a century of advances in science, the country failed to take full advantage of vaccines. On October 1, the U.S. passed 700,000 deaths. On October 18,
9676-648: 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
9794-436: 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,
9912-430: The first US surge of infections since the end of the public health emergency. Wastewater testing initially indicated that the uptick in cases was only a third the size of the previous summer's surge, yet data from Walgreens showed the first week of August having the largest number of positive cases since May 2021. Food and Drug Administration The United States Food and Drug Administration ( FDA or US FDA )
10030-447: The first few days [of January], which doesn't sound like a lot, but our community is very small," Henderson said. "The last couple of weeks, we have seen single digits every day. I certainly won't speak for other counties, but I think we're probably heading in that direction where if they're not closing down, they're decreasing hours and staff." On April 18, 2022, the federal transportation mask mandate, which had been extended to May 3 by
10148-401: The following days, more cases of the variant were reported in other states, leading former CDC director Tom Frieden to express his concerns that the U.S. will soon face "close to a worst-case scenario". It was believed the variant had been present in the U.S. since October. On January 19, the U.S. passed 400,000 deaths, just five weeks after the country passed 300,000 deaths. On January 22,
10266-467: The initial U.S. response to the pandemic was otherwise slow in terms of preparing the healthcare system, stopping other travel, and testing . The first known American deaths occurred in February and in late February President Donald Trump proposed allocating $ 2.5 billion to fight the outbreak. Instead, Congress approved $ 8.3 billion with only Senator Rand Paul and two House representatives ( Andy Biggs and Ken Buck ) voting against, and Trump signed
10384-555: The issuance of enforcement letters to pharmaceutical manufacturers. Advertising and promotion for over-the-counter drugs is regulated by the Federal Trade Commission . The FDA also implements regulatory oversight through engagement with third-party enforcer-firms. It expects pharmaceutical companies to ensure that third-party suppliers and labs comply with the agency's health and safety guidelines . The drug advertising regulation contains two broad requirements: (1)
10502-552: The mandate. The CDC was criticized for the confusion resulting from the announcement, as it did not remove existing state and local mandates. The guidance also did not remove the federal mask mandate on public transportation. On June 15, the U.S. passed 600,000 deaths, though the number of daily deaths had decreased due to vaccination efforts. By June, COVID-19 cases rose again, especially in Arkansas, Nevada, Missouri, and Wyoming. The rising numbers were believed to be attributable to
10620-596: The middle of March, all fifty states were able to perform tests with a doctor's approval, either from the CDC or from commercial labs. However, the number of available test kits remained limited. As cases began spreading throughout the nation, federal and state agencies began taking urgent steps to prepare for a surge of hospital patients. Among the actions was establishing additional places for patients in case hospitals became overwhelmed. Throughout March and early April, several state, city, and county governments imposed "stay at home" quarantines on their populations to stem
10738-450: The months leading up to November, deaths from COVID-19 substantially decreased, attributed to high levels of population immunity (through vaccination or prior infection), and improvements in early treatment for patients at risk for severe disease. The CDC recommended vaccinations, treatments for immunocompromised individuals and to reduce severity of the disease, and continuing to wear masks in public. Nonetheless, Dr. Anthony Fauci stated that
10856-555: The months of January through June 2022 was about 2.4 times the number for the same period in 2021, and the number of COVID-attributed deaths likewise averaged 0.74 times the number in 2021. Nonetheless, as of July 14, only 21 states have active COVID-19 emergency orders in place, and there are no state-level mask requirements still in force. The number of cases for July and August 2022 was 3,672,358 and 3,154,320, respectively, with 11,963 and 15,943 COVID-attributed deaths, respectively. The totals for these two months reflect about 1.6 times
10974-785: The most of any country, and the 17th highest per capita worldwide. The COVID-19 pandemic ranks as the deadliest disaster in the country's history . It was the third-leading cause of death in the U.S. in 2020, behind heart disease and cancer. From 2019 to 2020, U.S. life expectancy dropped by three years for Hispanic and Latino Americans , 2.9 years for African Americans , and 1.2 years for white Americans . In 2021, U.S. deaths due to COVID-19 rose, and life expectancy fell. Sources: Official reports from state health officials Sources: Official reports from state health officials In November 2019, COVID-19 infections had first broken out in Wuhan , China. China publicly reported
11092-494: The number of cases and 0.81 times the number of deaths from the same months in 2021. On September 18, 2022, in an appearance on 60 Minutes , president Joe Biden declared his belief that the COVID-19 pandemic was "over" in the United States. This assessment met some debate in the medical community: at the time, the United ;States had roughly 400 deaths from the disease per day, and when extrapolated to 150,000 per year
11210-569: The outbreak in China. Also, the first report of a COVID-19 case in the U.S. was publicly reported, though the All of Us study (released in 2021) showed five states already had cases weeks earlier. After other cases were reported, on January 30, the WHO declared a Public health emergency of international concern (PHEIC) – its highest level of alarm – warning that "all countries should be prepared for containment." The same day,
11328-470: The outbreak, but Congress instead approved $ 8.3 billion with only Senator Rand Paul and Representatives Andy Biggs and Ken Buck voting against, and Trump signed the bill on March 6. By March 11, the virus had spread to 110 countries, and the WHO officially declared a pandemic . The CDC had already warned that large numbers of people needing hospital care could overload the healthcare system, which would lead to otherwise preventable deaths. Director of
11446-559: The overall adult population having done so by July 4. On May 6, a study by the Institute for Health Metrics and Evaluation estimated that the true COVID-19 death toll in the U.S. was more than 900,000 people. On May 9, Dr. Fauci confirmed that the U.S. death toll was likely undercounted. On May 13, the CDC changed its guidance and said that fully vaccinated individuals do not need to wear masks in most situations. Some states ended their mask mandates shortly after, while others maintained
11564-399: The pandemic began. On December 14, the U.S. passed 300,000 deaths, representing an average of more than 961 deaths per day since the first known death on February 6. More than 50,000 deaths were reported in the past month, with an average of 2,403 daily deaths occurring in the past week. On December 24, following concerns over a probably more easily transmissible new SARS-CoV-2 variant from
11682-551: The pandemic reached the U.S., 100,000 Americans had died with COVID-19. State economic reopenings and lack of widespread mask orders resulted in a sharp rise in cases across most of the continental U.S. outside of the Northeast. A study conducted in May 2020 indicated that the true number of COVID-19 cases in the United States was much higher than the number of confirmed cases with some locations having 6–24 times higher infections, which
11800-533: 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
11918-422: 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 ,
12036-516: The prior year can be viewed via issuu (see External Links). COVID-19 pandemic in the United States On December 31, 2019, China announced the discovery of a cluster of pneumonia cases in Wuhan . The first American case was reported on January 20, and Health and Human Services Secretary Alex Azar declared a public health emergency on January 31. Restrictions were placed on flights arriving from China, but
12154-522: The program early, exchanging additional benefits for a new permanent program that provides extra money to low-income families to replace school meals during the summer. On April 10, 2023, President Biden signed into law a resolution terminating the national emergency, effective immediately. This national emergency was separate from the public health emergency, which remained in effect until May 11, 2023. A late-summer wave of COVID-19 cases, as reflected by tests at pharmacies and healthcare settings, marked
12272-551: The recent BA.4 and BA.5 variants and their risks are low, some experts recommend new strategies to develop vaccines with broader effectiveness. In a survey of vaccination booster intake (after completing a primary series), about 15% reported receiving the updated booster. The rates varied racially with 19% among White, non-Hispanic people, about 11% among Hispanic people, and about 7% among non-Hispanic American Indians, Alaska Native people, Black people, and those of multiple races, leading to concerns of vaccination access inequity. In
12390-580: The regulated industries. Rather, OCI agents pursue and develop cases when individuals and companies commit criminal actions, such as fraudulent claims or knowingly and willfully shipping known adulterated goods in interstate commerce. In many cases, OCI pursues cases involving violations of Title 18 of the United States Code (e.g., conspiracy, false statements, wire fraud, mail fraud), in addition to prohibited acts as defined in Chapter III of
12508-470: 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,
12626-816: The rise of the Alpha variant , a more easily transmissible variant first detected in the United Kingdom . That was followed by a rise of the Delta variant , an even more infectious mutation first detected in India , leading to increased efforts to ensure safety. The January 2022 emergence of the Omicron variant , which was first discovered in South Africa , led to record highs in hospitalizations and cases in early 2022, with as many as 1.5 million new infections reported in
12744-448: 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
12862-458: 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
12980-468: The spread of the virus. By March 26, The New York Times data showed the United States to have the highest number of known cases of any country. By March 27, the country had reported over 100,000 cases. On April 2, at President Trump's direction, the Centers for Medicare & Medicaid Services (CMS) and CDC ordered additional preventive guidelines to the long-term care facility industry. On April 11,
13098-626: The state after a Trump rally in Beltrami County, Minnesota . One case was traced to a Joe Biden rally in Duluth, Minnesota . On November 9, President-elect Biden's transition team announced his COVID-19 Advisory Board . On the same day, the total number of cases had surpassed ten million while the total had risen by over a million in the ten days prior, averaging 102,300 new cases per day. Pfizer also announced that its COVID-19 vaccine may be up to ninety percent effective. In November,
13216-579: The virus from a ski trip, Garfield was able to return to the slopes, although with some fingers and toes amputated. In February, Vice President Mike Pence took over for HHS Secretary Alex Azar as chair of the White House Coronavirus Task Force , with Trump saying, "We are very, very ready for this, for anything, whether it's going to be a breakout of larger proportions, or whether we're at that very low level." In late February Trump proposed allocating $ 2.5 billion to fight
13334-431: Was a sharp increase in reported incidents of xenophobia and racism against Asian Americans . Clusters of infections and deaths occurred in many areas. The COVID-19 pandemic also saw the emergence of misinformation and conspiracy theories , and highlighted weaknesses in the U.S. public health system. In the United States, there have been 103,436,829 confirmed cases of COVID-19 with 1,207,479 confirmed deaths,
13452-533: 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
13570-543: Was established by the 1902 Biologics Control Act , with additional authority established by the 1944 Public Health Service Act . Along with these Acts, the Federal Food, Drug, and Cosmetic Act applies to all biologic products, as well. Originally, the entity responsible for regulation of biological products resided under the National Institutes of Health ; this authority was transferred to the FDA in 1972. The Center for Devices and Radiological Health (CDRH)
13688-532: Was further confirmed by a later population-wide serosurvey. On July 6, the United States Department of State announced the country's withdrawal from WHO effective July 6, 2021. On July 10, the CDC adopted the Infection Fatality Ratio (IFR), "the number of individuals who die of the disease among all infected individuals (symptomatic and asymptomatic)", as a new metric for disease severity. In July, US PIRG and 150 health professionals sent
13806-438: Was held from April 24–30, with mayors and other political officials declaring the week of remembrance in their respective jurisdictions as part of a national movement led by a collection of COVID advocacy groups. According to data compiled by NBC News, the U.S. death toll reached 1 million on May 4, 2022, the largest-recorded death toll in any single country, followed by Brazil, with about 660,000 deaths. The White House confirmed
13924-683: Was reported by CNN that COVID-19 numbers reached pandemic lows across the US, resulting in many testing sites closing their doors. With testing sites seeing as low as single digits per day, Director of Public Health Services Division of the Haywood County Health and Human Services Agency in North Carolina Sarah Henderson suggested that she expected most counties to see closures soon, if they had not already. "We were seeing an excess of 100 patients at our testing site in
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