When was the FDA formed?
Pure Food and Drug Act
The 1906 Act paved the way for the eventual creation of the Food and Drug Administration (FDA) and is generally considered to be that agency's founding date, though the agency existed before the law was passed and was not named FDA until later. "While the Food and Drug act remains a foundational law of the FDA mission, it's not the law that created the FDA. [Initially,] the Bureau of Chemistry (the precursor to the FDA) regulated food safety. In 1927, the Bureau was reorganized into the Food, Drug, and Insecticide Administration and the Bureau of Chemistry and Soils. The FDIA was renamed the FDA in 1930."
Antibiotic misuse
Antibiotics have been around since 1928 when penicillin was discovered by Alexander Fleming. In the 1980s, antibiotics that were determined medically important for treatment of animals could be approved under veterinary oversight. In 1996, the National Antimicrobial Resistance Monitoring System (NARMS) was established. Starting in 2010, publications regarding antimicrobial drugs in food become an annual report. Starting in 2012, there was publicly solicited input on how data is to be collected and reported for matters relating to the use of antimicrobials for food-producing animals. Resulting from this, the FDA revised its sampling structure within NARMS with the goal of obtaining more representative livestock data for the key organisms under surveillance. “NARMS partners at CDC and USDA have published over 150 peer-reviewed research articles examining the nature and magnitude of antimicrobial resistance hazards associated with antibiotic use in food-producing animals.” In 2014, the FDA began working with the United States Department of Agriculture (USDA) and the Centers of Disease Control and Prevention (CDC) to explore additional mechanisms to obtain data that is representative of antibiotic use in food-producing animals. In 2015, the FDA issues the Veterinary Feed Directive (VFD) final rule. Under this rule veterinarians must authorize the use of antimicrobials within feed for the animals they serve.
History of the Food and Drug Administration
President Franklin Delano Roosevelt signed the new Food, Drug, and Cosmetic Act (FD&C Act) into law on June 24, 1938. The new law significantly increased federal regulatory authority over drugs by mandating a pre-market review of the safety of all new drugs, as well as banning false therapeutic claims in drug labeling without requiring that the FDA prove fraudulent intent. The law also authorized factory inspections and expanded enforcement powers, set new regulatory standards for foods, and brought cosmetics and therapeutic devices under federal regulatory authority. This law, though extensively amended in subsequent years, remains the central foundation of FDA regulatory authority to the present day.
Office of In Vitro Diagnostics and Radiological Health
In 1982, when the beginning of the biotechnology revolution blurred the lines between drugs, biologics, and medical devices, Commissioner Arthur Hayes reorganized the FDA. This reorganization merged the bureaus responsible for medical devices and radiation control into their present form, the Center for Devices and Radiological Health.
Drug Enforcement Administration
The Drug Enforcement Administration was established on July 1, 1973, by Reorganization Plan No. 2 of 1973, signed by President Richard Nixon on July 28. It proposed the creation of a single federal agency to enforce the federal drug laws as well as consolidate and coordinate the government's drug control activities. Congress accepted the proposal, as they were concerned with the growing availability of drugs. As a result, the Bureau of Narcotics and Dangerous Drugs (BNDD), the Office of Drug Abuse Law Enforcement (ODALE); approximately 600 Special Agents of the Bureau of Customs, Customs Agency Service, and other federal offices merged to create the DEA.
Retailer Owned Food Distributors &amp; Associates
Founded in 1962 by cooperative food distributors in the southeastern United States, the original organization’s name was Southeastern Food Cooperative Association (SFCA). In the 1980s, the organization expanded geographically out of the southeast, and in 1988 the name of the organization changed to Retailer Owned Food Distributors and Associates. In 1996, the organization incorporated as a cooperative. Before that it had been a nonprofit association. In 2012, ROFDA commemorated their 50th anniversary.
Global Harmonization Task Force
The Global Harmonization Task Force (GHTF) was “a voluntary group of representatives from national medical device regulatory authorities (such as the U.S. Food and Drug Administration (FDA)) and the members of the medical device industry” whose goal was the standardization of medical device regulation across the world. The representatives from its five founding members (the European Union, the United States, Canada, Japan and Australia) were divided into three geographical areas: Europe, Asia-Pacific and North America, each of which actively regulates medical devices using their own unique regulatory framework. Founded in 1992, the GHTF was created in “an effort to respond to the growing need for international harmonization in the regulation of medical devices."
Quackery
The end of the road for the quack medicines now considered grossly fraudulent in the nations of North America and Europe came in the early 20th century. February 21, 1906 saw the passage into law of the Pure Food and Drug Act in the United States. This was the result of decades of campaigning by both government departments and the medical establishment, supported by a number of publishers and journalists (one of the most effective was Samuel Hopkins Adams, who wrote "The Great American Fraud" series in "Collier's" in 1905). This American Act was followed three years later by similar legislation in Britain and in other European nations. Between them, these laws began to remove the more outrageously dangerous contents from patent and proprietary medicines, and to force quack medicine proprietors to stop making some of their more blatantly dishonest claims. The Act, however, left advertising and claims of effectiveness unregulated as the Supreme Court interpreted it to mean only that ingredients on labels had to be accurate. Language in the 1912 Sherley Amendment, meant to close this loophole, was limited to regulating claims that were false and fraudulent, creating the need to show intent. Throughout the early 20th century, the American Medical Association collected material on medical quackery, and one of their members and medical editors in particular, Arthur J. Cramp, devoted his career to criticizing such products. The AMA's Department of Investigation closed in 1975, but their only archive open to non-members remains, the American Medical Association Health Fraud and Alternative Medicine Collection.
Regulation of food and dietary supplements by the U.S. Food and Drug Administration
The regulation of food and dietary supplements by the U.S. Food and Drug Administration is a process governed by various statutes enacted by the United States Congress and interpreted by the U.S. Food and Drug Administration ("FDA"). Pursuant to the Federal Food, Drug, and Cosmetic Act ("the 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 about both the composition and the health benefits of foods.
Legal history of cannabis in the United States
In 1972, the National Organization for the Reform of Marijuana Laws petitioned the BNDD (which later became the DEA) to remove cannabis from the list of Schedule I drugs, in order to allow it to be prescribed by physicians. After a decade of legal battles in which the DEA refused to consider the petition, public hearings were finally held on the matter starting in 1986. In September 1988, after two years of extensive public hearings, DEA Chief Administrative Law Judge Francis L. Young ruled in favor of moving cannabis to a Schedule II classification, finding that "Marijuana, in its natural form, is one of the safest therapeutically active substances known to man." Young further concluded: "The evidence in this record clearly shows that marijuana has been accepted as capable of relieving the distress of great numbers of very ill people, and doing so with safety under medical supervision. It would be unreasonable, arbitrary and capricious for [the] DEA to continue to stand between those sufferers and the benefits of this substance in light of the evidence in this record." As Young's ruling was only a non-binding recommendation, however, it was rejected by DEA Administrator John Lawn in December 1989. The decision was upheld in 1994 by a U.S. Court of Appeals ruling.
United States v. Forty Barrels &amp; Twenty Kegs of Coca-Cola
In 1906, Harvey Washington Wiley was the first commissioner of the Food and Drug Administration (FDA) when Congress passed the Pure Food and Drug Act. The FDA started prosecuting companies which were selling products with harmful components and companies which were making misleading claims about their products. In 1903, Coca-Cola had already started using spent coca leaves (which only carried trace amounts of cocaine) and had dropped the claim that it cured headaches. But it still contained caffeine, and Wiley believed that even small amounts of caffeine in beverages were harmful to people, and he was worried that Coca-Cola was being consumed by children as young as 4 years old. So, in 1909, he ordered the seizure of 40 barrels and 20 kegs of a Coca-Cola shipment.
History of the Food and Drug Administration
By the 1930s, muckraking journalists, consumer protection organizations, and federal regulators began mounting a campaign for stronger regulatory authority by publicizing a list of injurious products which had been ruled permissible under the 1906 law, including radioactive beverages, the mascara Lash lure, which caused blindness, and worthless "cures" for diabetes and tuberculosis. The resulting proposed law was unable to get through the Congress of the United States for five years, but was rapidly enacted into law following the public outcry over the 1937 Elixir Sulfanilamide tragedy, in which over 100 people died after using a drug formulated with a toxic, untested solvent. The only way that the FDA could even seize the product was due to a misbranding problem: an "Elixir" was defined as a medication dissolved in ethanol, not the diethylene glycol used in the Elixir Sulfanilamide. Had it been labeled a "solution" instead, it is argued, the agency could have done nothing to track down and confiscate what medication remained in the public's hands.
FDA Food Safety Modernization Act
The first version of the law, the Food Safety Enhancement Act, passed the House on June 9, 2009. However, negotiations with the Senate led to the final product, the 'Food Safety and Modernization Act.' The bill was passed by the Senate in November 2010 by a vote of 73–25. However, because of a tax provision added to the bill, (which is constitutionally required to begin in the House), the vote did not count. There was concern that with the short time left in the lame-duck session, the bill would not get the time needed to be voted on and passed. Attempts to add the bill to the continuing resolution for government funding were scrapped over the objection of Senator Tom Coburn. Eventually, however, the Senate moved on December 19, 2010 to pass the fixed bill by unanimous consent by a voice vote. The House went on to approve the bill by a vote of 215 to 144 on December 21, 2010. President Barack Obama signed the bill into law on Tuesday, January 4, 2011.
Federal Bureau of Narcotics
Anslinger retired in 1962 and was succeeded by Henry Giordano, who was the commissioner of the FBN until it was merged in 1968 with the Bureau of Drug Abuse Control, an agency of the Food and Drug Administration, to form the Bureau of Narcotics and Dangerous Drugs, an agency of the United States Department of Justice. The BNDD was a predecessor agency of the current Drug Enforcement Administration (DEA).
United States Adopted Name
The USAN Council began in June 1961 after the AMA and the USP jointly formed the AMA-USP Nomenclature Committee. The American Pharmacists Association (APhA) became the third sponsoring organization in 1964, at which point the name of the committee was changed to the USAN Council, and United States Adopted Name became the official term to describe any nonproprietary name negotiated and formally adopted by the Council. In 1967, a liaison representative from the Food and Drug Administration (FDA) was appointed to serve on the USAN Council. The FDA announced in 1984 that it would discontinue adding drug names to its official list and use the USAN as the established name for labeling and advertising new single-entity drugs marketed in the United States. The AMA Council on Drugs no longer exists as a separate entity. FDA now has a representative on the USAN Council, which has moved away from chemically derived names.
History of the Food and Drug Administration
One of the most important statutes in establishing the modern American pharmaceutical market was the 1984 Drug Price Competition and Patent Term Restoration Act, more commonly known as the "Hatch-Waxman Act" after its chief sponsors. This act was intended to correct two unfortunate interactions between the new regulations mandated by the 1962 amendments, and existing patent law (which is not regulated or enforced by the FDA, but rather by the United States Patent and Trademark Office). Because the additional clinical trials mandated by the 1962 amendments significantly delayed the marketing of new drugs, without extending the duration of the manufacturer's patent, "pioneer" drug manufacturers experienced a decreased period of lucrative market exclusivity. On the other hand, the new regulations could be interpreted to require complete safety and efficacy testing for generic copies of approved drugs, and "pioneer" manufacturers obtained court decisions which prevented generic manufacturers from even beginning the clinical trial process while a drug was still under patent. The Hatch-Waxman Act was intended as a compromise between the "pioneer" and generic drug manufacturers which would reduce the overall cost of bringing generics to market and thus, it was hoped, reduce the long-term price of the drug, while preserving the overall profitability of developing new drugs.
Nondelegation doctrine
For example, the Food and Drug Administration (FDA) is an agency in the Executive branch created by Congress with the power to regulate food and drugs in the United States. Congress has given the FDA a broad mandate to ensure the safety of the public and prevent false advertising, but it is up to the agency to assess risks and announce prohibitions on harmful additives, and to determine the process by which actions will be brought based on the same. Similarly, the Internal Revenue Service has been given the responsibility of collecting taxes that are assessed under the Internal Revenue Code. Although Congress has determined the amount of the tax to be assessed, it has delegated to the IRS the authority to determine how such taxes are to be collected. Administrative agencies like these are sometimes referred to as the Fourth Branch of government.
Aspartame
Initially, aspartame was approved by the U.S. Food and Drug Administration (FDA) in 1974; however, problems with Searle's safety testing program, including testing of aspartame, were discovered subsequently. The approval was rescinded the following year; but, after outside reviews of the problematic tests and additional testing, final approval was granted in 1981. Because allegations of conflicts of interest marred the FDA's approval of aspartame, the U.S. Government Accountability Office reviewed the actions of involved officials in 1986 and the approval process in 1987; neither the allegations of conflict of interest nor problems in the final approval process were substantiated.
Prescription Drug User Fee Act
The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process. The Act provided that the FDA was entitled to collect a substantial application fee from drug manufacturers at the time a New Drug Application (NDA) or Biologics License Application (BLA) was submitted, with those funds designated for use only in Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) drug approval activities. In order to continue collecting such fees, the FDA is required to meet certain performance benchmarks, primarily related to the speed of certain activities within the NDA review process.
Food and Drug Administration
An initial attempt by the FDA to address this issue was the 1994 FDA Final Rule on Pediatric Labeling and Extrapolation, which allowed manufacturers to add pediatric labeling information, but required drugs that had not been tested for pediatric safety and efficacy to bear a disclaimer to that effect. However, this rule failed to motivate many drug companies to conduct additional pediatric drug trials. In 1997, the FDA proposed a rule to require pediatric drug trials from the sponsors of New Drug Applications. However, this new rule was successfully preempted in federal court as exceeding the FDA's statutory authority.
Office of National Narcotics Intelligence
The Office of National Narcotics Intelligence (ONNI) was a United States' federal law enforcement agency under the Justice Department that dealt in analysis of illegal drugs and was tasked to develop a National Narcotics Intelligence System. It conducted analysis only and had no operational responsibilities. Liaison was conducted with CIA and NSA. ONNI was founded in August 1972 under order of President Richard M. Nixon. The agency was headed by former FBI Assistant to the Director (third position in FBI after Director and Deputy Director) William C. Sullivan until ONNI was consolidated into the newly created Drug Enforcement Administration in July 1973 (along with the Bureau of Narcotics and Dangerous Drugs, the Office of Drug Abuse Law Enforcement, some Customs officers. Waldo H. Dubberstein, who worked in ONNI's Analysis Division, had been head of all Defense Intelligence Agency (DIA) analysis for the Middle East and South Asia, committed suicide in April 1983 after being indicted for selling classified DIA intelligence reports to Libya. It also helped set up information systems and analytical operations for the EU.
Food and Drug Administration
These reforms had the effect of increasing the time, and the difficulty, required to bring a drug to market. One of the most important statutes in establishing the modern American pharmaceutical market was the 1984 Drug Price Competition and Patent Term Restoration Act, more commonly known as the "Hatch-Waxman Act" after its chief sponsors. The act extended the patent exclusivity terms of new drugs, and tied those extensions, in part, to the length of the FDA approval process for each individual drug. For generic manufacturers, the Act created a new approval mechanism, the Abbreviated New Drug Application (ANDA), in which the generic drug manufacturer need only demonstrate that their generic formulation has the same active ingredient, route of administration, dosage form, strength, and pharmacokinetic properties ("bioequivalence") as the corresponding brand-name drug. This act has been credited with in essence creating the modern generic drug industry.
Regulation of tobacco by the U.S. Food and Drug Administration
The Center for Tobacco Products is the newest branch of the FDA, and officially was opened on August 19, 2009. Lawrence Deyton, M.D., M.S.P.H, was appointed the first director of the center. Mitch Zeller, JD, became the Director of CTP in March 2013. Zeller was the associate commissioner and director of FDA's first Office of Tobacco Programs until 2000, when the Supreme Court decided that Congress did not give the FDA authority over tobacco products and tobacco product marketing.
Combined Food Board
The Combined Food Board was a temporary World War II government agency that allocated the combined economic resources of the United States and the United Kingdom. It was set up by President Franklin D. Roosevelt and Prime Minister Winston Churchill on June 9, 1942. Canada, after insisting on its economic importance, was given a place on the board in November, 1942. At first the Board was a pawn in a battle between the U.S. Department of Agriculture and the U.S. War
Food Administration. After that was resolved, the Board ran smoothly, and effectiveness increased. Its major achievement was the multi-nation commodity committees that it set up in 1945, which became the International Emergency Food Council. It tried to organize responses to a massive shortage of food in war-torn areas. It closed in 1946.
Fecal microbiota transplant
In the United States, the FDA announced in February 2013 that it would hold a public meeting entitled "Fecal Microbiota for Transplantation" which was held on May 2–3, 2013. In May 2013 the FDA also announced that it had been regulating human fecal material as a drug. The American Gastroenterological Association (AGA), the American College of Gastroenterology (ACG), the American Society for Gastrointestinal Endoscopy (ASGE), and the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) sought clarification, and the FDA Center for Biologics Evaluation and Research (CBER) stated that FMT falls within the definition of a biological product as defined in the Public Health Service Act and the definition of a drug within the meaning of the Federal Food, Drug, and Cosmetic Act. It argued since FMT is used to prevent, treat, or cure a disease or condition, and intended to affect the structure or any function of the body, "a product for such use" would require an Investigational New Drug (IND) application.
Health department
At the national level, a simple National Board of Health functioned from 1879-1883, but it was not until 1939 that another federal agency that operated to manage public health on a national level was established, going from a federal agency called the Federal Security Agency that had health functions such as the United States Public Health Service (PHS), and the United States Food and Drug Administration (FDA). In 1953, that agency was reorganized and its health functions were elevated to a cabinet-level position to establish the United States Department of Health, Education and Welfare (HEW), which was renamed in 1980 to become the current and modern United States Department of Health and Human Services (HHS).
Frederick C. Kulow
Kulow's greatest contribution to the natural foods industry is considered to be his victory over the U.S. Food and Drug Administration concerning the ability to sell essential fatty acids. The Food and Drug Administration (FDA) argued that EFAs (e.g., evening primrose oil, flax oil, borage oil, black currant oil and combinations) were unapproved food additives. Kulow's victory was significant because the Dietary Supplement Health and Education Act was altered to bar the FDA from using the "unapproved additive" argument to regulate dietary supplements.
Organophosphate
Organophosphates (OPs) were among the most widely used insecticides until the 21st century. And until the mid 1990s, general pesticide regulation was dependent on the Federal Food, Drug and Cosmetic Act (FFDCA) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) passed in 1938 and 1947, respectively. In 1993, the Environmental Protection Agency (EPA) was bound by a pledge made to Congress to significantly reduce the amount of pesticides used in the United States, and the U.S. Department of Agriculture, along with the Food and Drug Administration, joined the EPA in this commitment. Then, in 1996, The Food Quality Protection Act (FQPA) was signed into law to strengthen the regulation of pesticide in food and make regulation practices more consistent. One way that this strengthening was accomplished was through mandating aggregate and cumulative exposure risk assessments in derivative food tolerance levels. The EPA selected OPs as the first class of pesticides for assessing food tolerances because of their specific toxicity behavior as acetylcholinesterase inhibitors.
Enterprise Florida
Florida Defense Alliance (FDA) was created in 1998 as a non-profit partnership between the Governor, Florida state officials, the Florida Congressional Delegation, state legislators, base commanders and staff, community leaders, and business executives. FDA's mission is to increase military value, enhance base capabilities, and promote multi-service synergies for Florida’s military bases, while supporting and enhancing the quality of life of Florida military families.
George P. Larrick
George P. Larrick (November 19, 1901August 11, 1968) was Commissioner of the U.S. Food and Drug Administration (FDA) from 19541965.
Florida Dental Association
The Florida Dental Association (also abbreviated as FDA) is an organization of dentists in Florida, United States, and it was established in 1884. Currently, there are approximately 7,000 members in the FDA.
Pharmaceutical Research and Manufacturers of America
Pharmaceutical Research and Manufacturers of America (PhRMA, pronounced ), formerly known as the Pharmaceutical Manufacturers Association, is a trade group representing companies in the pharmaceutical industry in the United States founded in 1958. PhRMA's stated mission is advocacy for public policies that encourage the discovery of new medicines for patients by companies engaged in pharmaceutical and biopharmaceutical research. Steve Ubl became PhRMA's chairman in September 2015. PhRMA is headquartered in Washington, DC.
Manhattan Institute for Policy Research
The Institute formed its Project FDA in 2006 to focus on ways to improve FDA regulations and create a faster, safer drug and medical-device pipeline. Notable members of the committee include former FDA commissioner Andrew C. von Eschenbach and former Oklahoma senator (now Institute senior fellow) Tom Coburn.
Donald Kennedy
For 26 months he served as Commissioner of the United States Food and Drug Administration during the Carter Administration. Having been appointed by the Secretary of Health, Education, and Welfare, Joseph Califano, in April 1977, in the next two-plus years Kennedy and the FDA dealt with issues such as the fallout from the attempt to ban saccharin, and the risks of antibiotic resistance in humans from agricultural antibiotic use and worked on provisions of the proposed Drug Regulation Reform Act of 1978.
Federal Food, Drug, and Cosmetic Act
The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C), is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. Senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism preparations.
Food and Drug Administration Safety and Innovation Act
The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012. It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics. It also creates the breakthrough therapy designation program and extends the priority review voucher program to make eligible rare pediatric diseases. The measure was passed by 96 senators voting for and one voting against.
Food and Drug Administration
Most federal laws concerning the FDA are part of the Food, Drug and Cosmetic Act, (first passed in 1938 and extensively amended since) and are codified in Title 21, Chapter 9 of the United States Code. Other significant laws enforced by the FDA include the Public Health Service Act, parts of the Controlled Substances Act, the Federal Anti-Tampering Act, as well as many others. In many cases these responsibilities are shared with other federal agencies.
Health departments in the United States
At the national level, a simple National Board of Health functioned from 1879–1883. Not until 1939 was another federal agency established to manage public health on a national level. It went through several iterations a federal agency called the Federal Security Agency that had health functions such as the United States Public Health Service (PHS), and the United States Food and Drug Administration (FDA). In 1953, that agency was reorganized and its health functions were elevated to a cabinet-level position to establish the United States Department of Health, Education and Welfare (HEW), which was renamed in 1980 to become the current and modern United States Department of Health and Human Services (HHS).
Criticism of the Food and Drug Administration
After his resignation, from his post as Commissioner of the Food and Drugs Administration in December 1969, Dr. Herbert L. Ley, Jr. In an interview to "The New York Times", warned the public about the FDA’s inability to safeguard consumers. People were being misled, he believed “The thing that bugs me is that the people think the FDA is protecting them - it isn’t. What the FDA is doing and what the public thinks it’s doing are as different as night and day,” he said. The agency, in his opinion, did not have the motivation to protect consumers, faced budget shortfalls, and lacked support from the Department of Health, Education, and Welfare. Dr. Ley was critical of Congress, the Administration and the drug industry, stating that he had "constant, tremendous, sometimes unmerciful pressure" from the drug industry, and that the drug company lobbyists, combined with the politicians who worked on behalf of their patrons, could bring “tremendous pressure” to bear on him and his staff, to try preventing FDA restrictions on their drugs. Ley stated that the entire issue was about money, “pure and simple”. On December 15, 1999, interviewed for the oral history program of the FDA History Office, Dr. Ley shared that from the first controversy in his tenure as FDA Commissioner he had a "gut feeling" that his life expectancy at the FDA was probably limited. He said he had done everything by the book, both in the FDA and the Department of Health, Education, and Welfare, and he thinks that what the Administration was really wishing, was that he would stonewall the whole Academy report, because it was goring too many pharmaceutical companies.
Consumer health laws
Office of the Commissioner. (2018, February 01). FDA's Evolving Regulatory Powers - Milestones in U.S. Food and Drug Law History. Retrieved April 20, 2018, from https://www.fda.gov/AboutFDA/WhatWeDo/History/FOrgsHistory/EvolvingPowers/ucm2007256.htm
Human subject research
Ethical guidelines that govern the use of human subjects in research are a fairly new construct. In 1906 some regulations were put in place in the United States to protect subjects from abuses. After the passage of the Pure Food and Drug Act in 1906, regulatory bodies such as the Food and Drug Administration (FDA) and institutional review boards (IRBs) were gradually introduced. The policies that these institutions implemented served to minimize harm to the participant's mental and/or physical well being.
Barbara Browne
Employed by the Food and Drug Administration in 1955 Browne saw the fraud within the administration. Fifteen years later Browne resigned from the FDA. She shifted her efforts towards creating better quality of drug approval. After testifying before the Kefauver Senate Subcommittee, the United States Congress modified the drug approval process. Browne worked with the Bureau of Deceptive Practices at the Federal Trade Commission as a medical officer in order to bring to light the ethical issues present within the Food and Drug Administration.
Alliance for Natural Health USA
In April 2011, a U.S. federal judge ruled against a legal challenge by the ANH to the U.S. Food and Drug Administration's adoption of new manufacturing regulations. U.S. District Judge Beryl Howell found that the regulations "did not exceed the FDA's statutory authority, are not impermissibly vague under the due process clause, and are not arbitrary and capricious under the Administrative Procedure Act." The complaint was filed in 2009 by the ANH, along with Durk Pearson, Sandy Shaw and the Coalition to End FDA and FTC Censorship.
Copper IUDs
The ParaGard T 380A was developed in the 1970s by the Population Council and Finishing Enterprises Inc. (FEI). The Population Council's ParaGard new drug application (NDA) was approved by the U.S. Food and Drug Administration (FDA) and FEI began manufacturing it for distribution outside the United States in 1984. GynoPharma (originally GynoMed) began marketing it in the U.S. in May 1988. On August 2, 1995, Ortho-McNeil acquired GynoPharma and began marketing ParaGard in the U.S. On January 1, 2004, FEI Women's Health acquired the patent from the Population Council and U.S. marketing rights from Ortho-McNeil. On November 10, 2005, Duramed Pharmaceuticals, a subsidiary of Barr Pharmaceuticals, acquired FEI Women's Health and ParaGard. On July 18, 2008, it was announced that Teva Pharmaceutical Industries Ltd. would acquire Barr Pharmaceuticals.
Controlled Substances Act
The Drug Enforcement Administration was established in 1973, combining the Bureau of Narcotics and Dangerous Drugs (BNDD) and Customs' drug agents. Proceedings to add, delete, or change the schedule of a drug or other substance may be initiated by the DEA, the Department of Health and Human Services (HHS), or by petition from any interested party, including the manufacturer of a drug, a medical society or association, a pharmacy association, a public interest group concerned with drug abuse, a state or local government agency, or an individual citizen. When a petition is received by the DEA, the agency begins its own investigation of the drug.
Pesticide regulation in the United States
The Delaney House Committee hearings in 1950-51 were the first instance of government hearings concerning pesticide safety. The hearings resulted in two amendments to the Federal Food, Drug and Cosmetic Act: The Pesticides Control Amendment (PCA) and the Food Additives Amendment (FAA). These two amendments resulted in Food and Drug Administration (FDA) involvement in pesticide regulation. The PCA of 1954 was the first time Congress passed guidance regarding the establishment of safety limits for pesticide residues on food. PCA authorized the FDA to ban pesticides they determined to be unsafe if they were sprayed directly on food. The Food Additives Amendment, which included the Delaney Clause, prohibited the pesticide residues from any carcinogenic pesticides in processed food. In 1959, FIFRA was amended requiring that pesticides be registered.
History of the Food and Drug Administration
This article is about the history of the United States Food and Drug Administration.
Medical research
Regulation on industry funded biomedical research has seen great changes since Samuel Hopkins Adams declaration. In 1906 congress passed the Pure Food and Drugs Act of 1906. In 1912 Congress passed the Shirley Amendment to prohibit the wide dissemination of false information on pharmaceuticals. The Food and Drug Administration was formally created in 1930 under the McNarey Mapes Amendment to oversee the regulation of Food and Drugs in the United States. In 1962 the Kefauver-Harris Amendments to the Food, Drug and Cosmetics Act made it so that before a drug was marketed in the United States the FDA must first approve that the drug was safe. The Kefauver-Harris amendments also mandated that more stringent clinical trials must be performed before a drug is brought to the market. The Kefauver-Harris amendments were met with opposition from industry due to the requirement of lengthier clinical trial periods that would lessen the period of time in which the investor is able to see return on their money. In the pharmaceutical industry patents are typically granted for a 20-year period of time, and most patent applications are submitted during the early stages of the product development. According to Ariel Katz on average after a patent application is submitted it takes an additional 8 years before the FDA approves a drug for marketing. As such this would leave a company with only 12 years to market the drug to see a return on their investments. After a sharp decline of new drugs entering the US market following the 1962 Kefauver-Harris amendments economist Sam Petlzman concluded that cost of loss of innovation was greater than the savings recognized by consumers no longer purchasing ineffective drugs. In 1984 the Hatch-Waxman Act or the Drug Price Competition and Patent Term Restoration Act of 1984 was passed by congress. The Hatch-Waxman Act was passed with the idea that giving brand manufacturers the ability to extend their patent by an additional 5 years would create greater incentives for innovation and private sector funding for investment.
Reagan-Udall Foundation
The Reagan-Udall Foundation is a private nonprofit (501c3) organization, created to support the mission of the U.S. Food and Drug Administration (FDA) to help equip FDA staff with the highest caliber, regulatory science and technology in order to enhance the safety and effectiveness of FDA regulated products. Although it was mandated by Congress in the Food and Drug Administration Amendments Act of 2007 to help support and promote FDA's regulatory science priorities, it is independent of the agency, with its own Board of Directors, staff and research agenda. The Reagan-Udall Foundation creates public-private partnerships to advance research in regulatory science, enhance medical decision making, and promote innovation. It also advances regulatory science through fellowships and other training programs, both for private scientists and for FDA staff.
Food and Drug Administration
The original authority for government regulation of biological products was established by the 1902 Biologics Control Act, with additional authority established by the 1944 Public Health Service Act. Along with these Acts, the Federal Food, Drug, and Cosmetic Act applies to all biologic products, as well. Originally, the entity responsible for regulation of biological products resided under the National Institutes of Health; this authority was transferred to the FDA in 1972.
Good clinical practice
The first indicator in the regulation of drugs is the Food and Drugs Act established in the US in 1906. It is considered to be the result of very dangerous and even deadly drugs that could have been sold legally just like any other medical goods. For example, such drugs were ‘Grandma’s Secret’ and ‘Kopp’s Baby’s Friend’, which contained a huge amount of morphine. ‘Dr King’s Consumption Cure’ and ‘Dr Bull’s Cough Syrup‘ are examples of drugs which had large doses of morphine and chloroform as well.
Food and Drug Administration
In 2006, a congressionally requested committee was appointed by the Institute of Medicine to review pharmaceutical safety regulation in the U.S. and to issue recommendations for improvements. The committee was composed of 16 experts, including leaders in clinical medicinemedical research, economics, biostatistics, law, public policy, public health, and the allied health professions, as well as current and former executives from the pharmaceutical, hospital, and health insurance industries. The authors found major deficiencies in the current FDA system for ensuring the safety of drugs on the American market. Overall, the authors called for an increase in the regulatory powers, funding, and independence of the FDA. Some of the committee's recommendations have been incorporated into drafts of the PDUFA IV bill, which was signed into law in 2007.
Food and Drug Administration Modernization Act of 1997
The United States Food and Drug Administration Modernization Act of 1997 (FDAMA) amended the Federal Food, Drug, and Cosmetic Act. This act is related to the regulation of food, drugs, devices, and biological products by the FDA. These changes were made in order to recognize the changes in the way the FDA would be operating in the 21st century. The main focus of this is the acknowledgment in the advancement of technological, trade, and public health complexities.
Health care in the United States
The Food and Drug Administration (FDA) is the primary institution tasked with the safety and effectiveness of human and veterinary drugs. It also is responsible for making sure drug information is accurately and informatively presented to the public. The FDA reviews and approves products and establishes drug labeling, drug standards, and medical device manufacturing standards. It sets performance standards for radiation and ultrasonic equipment.
Food policy
The history of food policy in the United States started in the 1880s with policies being carried out by the U.S. Department of Agriculture. In 1883, Harvey W. Wiley, M.D., was appointed chief chemist at USDA. Wiley devoted his career to raising public awareness of problems with adulterated food; developing standards for food processing; and campaigning for the Pure Food and Drug Act, also known as the "Wiley Act". For much of the 1880s, policymakers discussed how to deal with diseased livestock being imported into or exported out of the United States. In 1884, the USDA Bureau of Animal Industry (BAI) was created with the purpose of ensuring that diseased livestock could not be used as food. In 1890, the BAI was charged also with testing meats being exported from the U.S. and ensuring these were disease-free. In 1906, the Pure Food and Drug Act and the Federal Meat Inspection Act (FMIA) were both signed into law. Both prevent production and sale of adulterated or misbranded foods, the Pure Food and Drug Act focusing on general foods, and FMIA focusing on meats.
Pesticide regulation in the United States
In 1970, President Richard Nixon created the Environmental Protection Agency (EPA) and shifted control of pesticide regulation from USDA, DOI, and FDA to the newly created EPA. By this time public awareness of potential human health and environmental health effects had increased. In addition, some members of congress began to express concerns about the adequacy of pesticide regulation. The growing public concern created political pressure for pesticide regulation reform. These changes contributed to an environment that enabled an overhaul of pesticide regulation. FIFRA was amended in 1972 by the Federal Environmental Pesticides Control Act (FEPCA). FEPCA required manufacturers of new pesticides to perform a variety of tests to prove that the pesticide did not have "unreasonable adverse effects" on human health or the environment. Already registered pesticides were to be reregistered using these new requirements. The EPA was given the authority to refuse registration to any pesticide it concluded had risks for humans, wildlife, and/or the environment that outweighed the pesticide's benefits. In addition, pesticide registration data was required to be made available to the public after a pesticide had been registered. Pesticides that had been registered prior to 1972 could only be banned after a special review board was convened and determined the pesticide was hazardous. If this occurred, the indemnity clause of FEPCA required the EPA to compensate pesticide manufacturers, distributors, and users for the value of any unused stock they possessed. FEPCA also required EPA to review the registration data from pesticides registered prior to 1972, but did not appropriate funds for the task.
The reregistration process was beset by difficulties throughout the 1970s. FEPCA required the reregistration process to be complete by 1976; however EPA did not begin reregistration until the fall of 1975. Shortly after beginning the reregistration process, congressional investigations revealed that the EPA was taking shortcuts that undermined the purpose of reregistration. EPA was confirming the presence of registration data rather than determining whether the data was adequate. Shortly after this was revealed, an investigation into Industrial Bio-Test Laboratories (IBT) found that it had been routinely falsifying tests. IBT was the nation's largest independent laboratory that conducted toxicity tests. The EPA and the Canadian Department of Health and Welfare determined that "only about 10% of the over 2000 IBT studies which had been submitted in support of pesticide registrations were valid." After these two setbacks, EPA suspended its reregistration program in August 1976. EPA did not restart reregistrations until 1978.
Foreign Agricultural Service
After a nine-year hiatus from international agricultural development work at USDA, on July 12, 1963, Secretary Orville Freeman ordered creation of an International Agricultural Development Service (IADS), which was subordinate to the same Assistant Secretary of Agriculture as but separate from FAS. IADS served as USDA's liaison with USAID and other assistance organizations, linking them to USDA expertise in pursuit of developmental goals. Matthew Drosdoff was hired effective February 19, 1964, to be the first permanent Administrator of IADS. In March 1969, after the Richard Nixon Administration came to power, IADS was briefly merged into FAS, then in November 1969 was split out into a separate Foreign Economic Development Service (FEDS). On February 6, 1972, FEDS was abolished and its functions transferred to the Economic Research Service, where it became the Foreign Development Division.
Pure Food and Drug Act
The Pure Food and Drug Act of 1906 was a key piece of Progressive Era legislation, signed by President Theodore Roosevelt on the same day as the Federal Meat Inspection Act. Enforcement of the Pure Food and Drug Act was assigned to the Bureau of Chemistry in the U.S. Department of Agriculture which was renamed the U.S. Food and Drug Administration (FDA) in 1930. The Meat Inspection Act was assigned to what is now known as the Food Safety and Inspection Service, which remains in the U.S. Department of Agriculture. The first federal law regulating foods and drugs, the 1906 Act's reach was limited to foods and drugs moving in interstate commerce. Although the law drew upon many precedents, provisions, and legal experiments pioneered in individual states, the federal law defined "misbranding" and "adulteration" for the first time and prescribed penalties for each. The law recognized the U.S. Pharmacopeia and the National Formulary as standards authorities for drugs, but made no similar provision for federal food standards. The law was principally a "truth in labeling" law designed to raise standards in the food and drug industries and protect the reputations and pocketbooks of honest businessmen.
Meat packing industry
The Pure Food and Drug Act of 1906 was the first of a series of legislation that led to the establishment of the Food and Drug Administration (FDA). Another such act passed the same year was the Federal Meat Inspection Act. The new laws helped the large packers, and hurt small operations that lacked economy of scale or quality controls.
Mundo Sano
In 2017, August 29 the U.S. Food and Drug Administration (FDA) approved Chemo Research’s New Drug Application (NDA) for benznidazole 567891011 . This is the first drug ever approved by the FDA to treat Chagas disease. The FDA’s decision approves benznidazole for children ages 2–12 years old 12. Mundo Sano played a central role in registering benznidazole with the U.S. Food and Drug Administration (FDA), in close collaboration with Exeltis (Chemo US-based pharmaceutical division), with the support of the Drugs for Neglected Diseases initiative (DNDi), a non-profit drug development organization.
Food and Drug Administration (Myanmar)
The Department of Food and Drug Administration (; abbreviated FDA) is Burma's food safety regulatory body, which oversees the safety and quality of food, drugs, medical devices and cosmetics. FDA was established in 1995. The agency was established under the 1992 National Drug Law, which also established the Food and Drug Board of Authority, which regulates and controls the manufacture, import, export, storage,
distribution and sale of food and drugs, in the interests of public safety.
Patient safety organization
The FDA launched a new program in 2005 to provide drug risk information directly to the public through internet-accessible drug sheets and bulletins. The enactment of the Food and Drug Administration Amendments Act of 2007 (FDAAA), expanded the authority of the FDA over drug safety monitoring after approval and introduction for use by the public. In 2008, the FDA established a single website for both the public and the healthcare profession with access to drug safety information, including warnings, recalls, and reporting of adverse reactions, using MedWatch.
Legal history of cannabis in the United States
In 1973 President Richard Nixon's "Reorganization Plan Number Two" proposed the creation of a single federal agency to enforce federal drug laws and Congress accepted the proposal, as there was concern regarding the growing availability of drugs. As a result, on July 1, 1973, the Bureau of Narcotics and Dangerous Drugs (BNDD) and the Office of Drug Abuse Law Enforcement (ODALE) merged to create the Drug Enforcement Administration (DEA). On December 1, 1975, the Supreme Court ruled that it was "not cruel or unusual for Ohio to sentence someone to 20 years for having or selling cannabis".
Food and Drug Administration
President Franklin Delano Roosevelt signed the new Food, Drug, and Cosmetic Act (FD&C Act) into law on June 24, 1938. The new law significantly increased federal regulatory authority over drugs by mandating a pre-market review of the safety of all new drugs, as well as banning false therapeutic claims in drug labeling without requiring that the FDA prove fraudulent intent. Soon after passage of the 1938 Act, the FDA began to designate certain drugs as safe for use only under the supervision of a medical professional, and the category of "prescription-only" drugs was securely codified into law by the 1951 Durham-Humphrey Amendment. These developments confirmed extensive powers for the FDA to enforce post-marketing recalls of ineffective drugs.
Pure Food and Drug Act
It took 27 years to the 1906 statute, during which time the public was made aware of many problems with foods and drugs in the U.S. Muckraking journalists, such as Samuel Hopkins Adams, targeted the patent medicine industry with its high-alcoholic content patent medicines, soothing syrups for infants with opium derivatives, and "red clauses" in newspaper contracts providing that patent medicine ads (upon which most newspapers of the time were dependent) would be withdrawn if the paper expressed support for food and drug regulatory legislation. The Chief Chemist of the Bureau of Chemistry, Dr. Harvey Washington Wiley, captured the country's attention with his hygienic table studies, which began with a modest Congressional appropriation in 1902. The goal of the table trial was to study the human effects of common preservatives used in foods during a period of rapid changes in the food supply brought about by the need to feed cities and support an industrializing nation increasingly dependent on immigrant labor. Wiley recruited young men to eat all their meals at a common table as he added increased "doses" of preservatives including borax, benzoate, formaldehyde, sulfites, and salicylates. The table trials captured the nation's fancy and were soon dubbed "The Poison Squad" by newspapers covering the story. The men soon adopted the motto "Only the Brave dare eat the fare" and at times the publicity given to the trials became a burden. Though many results of the trial came to be in dispute, there was no doubt that formaldehyde was dangerous and it disappeared quickly as a preservative. Wiley himself felt that he had found adverse effects from large doses of each of the preservatives and the public seemed to agree with Wiley. In many cases, most particularly with ketchup and other condiments, the use of preservatives was often used to disguise insanitary production practices. Although the law itself did not proscribe the use of some of these preservatives, consumers increasingly turned away from many products with known preservatives.
Manhattan Institute for Policy Research
Since 2006, the Institute's Project FDA has been at the forefront of advocating for FDA reform. With modern medicine on the cusp of a radical transformation due to breakthroughs in precision medicine, the FDA has struggled to adapt its regulations to new scientific advances. Senior fellows Paul Howard, Peter Huber, and Tom Coburn have all argued that the FDA can be a bridge for innovation, rather than a barrier, getting better medicines to patients, faster, without sacrificing safety. In October 2015, the Institute ran a full-page advertisement in the New York Times, reading, "Everyone will be a patient someday". The ad included the signatures of over a dozen industry leaders, all in support of the passage of the 21st Century Cures Act, which was signed into law by President Obama just over a year later, in December 2016.
Food and Drug Administration
The regulation of food and dietary supplements by the U.S. 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 ("the 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 about both the composition and the health benefits of foods.
George P. Larrick
Following the war, he served as Assistant Commissioner, Associate Commissioner and finally Deputy Commissioner of the FDA. In 1954, he was appointed Commissioner, succeeding Charles Crawford. Commissioner Larrick headed the FDA during the period of its greatest growth. In 1954, the Agency had less than 1,000 employees to regulate more than one fourth of the nation's commerce in consumer goods. The First Citizen's Advisory Committee report became the blueprint for extensive changes in the organization and a rapid increase in its resources. During Larrick's tenure, FDA appropriations increased more than tenfold, from $5 million to over $50 million, and its staff expanded to almost 4,000. The building program inaugurated during Larrick's administration provided modern laboratories for a majority of the FDA field districts and a $25 million headquarter's laboratory. His last official act was its dedication in December 1965.
Orphan drug
The Orphan Drug Act (ODA) of January 1983, passed in the United States, with lobbying from the National Organization for Rare Disorders and many other organizations, is meant to encourage pharmaceutical companies to develop drugs for diseases that have a small market. Under the ODA drugs, vaccines, and diagnostic agents would qualify for orphan status if they were intended to treat a disease affecting less than 200,000 American citizens. Under the ODA orphan drug sponsors qualify for seven-year FDA-administered market Orphan Drug Exclusivity (ODE), "tax credits of up to 50% of R&D costs, R&D grants, waived FDA fees, protocol assistance and may get clinical trial tax incentives.
Food and Drug Administration
The Office of Criminal Investigations was established in 1991 to investigate criminal cases. Unlike ORA Investigators, OCI Special Agents are armed, and don't focus on technical aspects of the regulated industries. OCI agents pursue and develop cases where individuals and companies have committed criminal actions, such as fraudulent claims, or knowingly and willfully shipping known adulterated goods in interstate commerce. In many cases, OCI pursues cases involving Title 18 violations (e.g., conspiracy, false statements, wire fraud, mail fraud), in addition to prohibited acts as defined in Chapter III of the FD&C Act. OCI Special Agents often come from other criminal investigations backgrounds, and work closely with the Federal Bureau of Investigation, Assistant Attorney General, and even Interpol. OCI receives cases from a variety of sources—including ORA, local agencies, and the FBI—and works with ORA Investigators to help develop the technical and science-based aspects of a case. OCI is a smaller branch, comprising about 200 agents nationwide.
Reference Daily Intake
The Food and Nutrition Board subsequently revised the RDAs every five to ten years. In 1973, the FDA introduced regulations to specify the format of nutrition labels when present, although the inclusion of such labels was largely voluntary, only being required if nutrition claims were made or if nutritional supplements were added to the food. The nutrition labels were to include percent U.S. RDA based on the 1968 RDAs in effect at the time. The RDAs continued to be updated (in 1974, 1980 and 1989) but the values specified for nutrition labelling remained unchanged.
Family Smoking Prevention and Tobacco Control Act
On March 21, 2000, the Supreme Court in "FDA v. Brown & Williamson Tobacco Corp.", in a 5-4 decision, held that the Federal Food, Drug, and Cosmetic Act, particularly when considering "Congress’ subsequent tobacco-specific legislation," that Congress had not given the FDA the authority to regulate tobacco products as customarily marketed. Thus the Family Smoking Prevention and Tobacco Control Act was introduced to respond to the decision, which had held that the Clinton administration's FDA had "overreached" its Congressionally delegated authority, thus giving the FDA the authority the Court determined it had lacked.
National Women's Health Network
In its first year, the NWHN organized the first ever protest against the U.S. Food and Drug Administration (FDA). In 1975, organizers opposed to the FDA approval and lack of oversight of synthetic estrogens such as DES and high-dose estrogens in combined oral contraceptive pills carried signs reading "Feed Estrogen to the Rats at the FDA" and "Women's Health, Not Drug Company Wealth". After the protests and the Nelson Pill Hearings, Patient Packaging Inserts (PPIs) listing side effects were instated for oral contraceptives—the first PPIs in U.S. history.
The National Women's Health Network helped found Raising Women's Voices, a national initiative that advocates affordable healthcare for everyone. Raising Women's Voices wants to ensure the national discourse on healthcare reform takes the needs of women into account. Other founding members include Mergerwatch and the Avery Institute for Social Change. Raising Women's Voices includes a list of 26 principles including:The NWHN publishes independently researched fact sheets and position papers on a variety of women's health topics including breast cancer, endometriosis, cervical cancer, fibroids, menopause and hormonal therapy, mammograms, abortion, and hysterectomy. Every publication is from an objective, feminist perspective without endorsing any specific treatment plan or method.
History of the Food and Drug Administration
Up until the 20th century, there were few federal laws regulating the contents and sale of domestically produced food and pharmaceuticals, with one exception being the short-lived Vaccine Act of 1813. A patchwork of state laws provided varying degrees of protection against unethical sales practices, such as misrepresenting the ingredients of food products or therapeutic substances. The history of the FDA can be traced to the latter part of the 19th century and the U.S. Department of Agriculture's Division of Chemistry (later Bureau of Chemistry). Under Harvey Washington Wiley, appointed chief chemist in 1883, the Division began conducting research into the adulteration and misbranding of food and drugs on the American market. Although they had no regulatory powers, the Division published its findings from 1887 to 1902 in a ten-part series entitled "Foods and Food Adulterants". Wiley used these findings, and alliances with diverse organizations such as state regulators, the General Federation of Women's Clubs, and national associations of physicians and pharmacists, to lobby for a new federal law to set uniform standards for food and drugs to enter into interstate commerce. Wiley's advocacy came at a time when the public had become aroused to hazards in the marketplace by muckraking journalists like Upton Sinclair, and became part of a general trend for increased federal regulations in matters pertinent to public safety during the Progressive Era. The 1902 Biologics Control Act was put in place after diphtheria antitoxin was collected from a horse named Jim who contracted tetanus, resulting in several deaths.
Much credit is given to the deaths of many people in the 1930s, including Eben Byers in 1932 from the ingestion of radithor and many women, some known as The Radium Girls, to making the FDA into the much more powerful organization we know today.
Medical cannabis in the United States
The classification of cannabis as a Schedule I drug was first challenged by the National Organization for the Reform of Marijuana Laws (NORML) in a 1972 petition to the Bureau of Narcotics and Dangerous Drugs (which was merged with other agencies to form the DEA in 1973). After a decade of legal battles in which the DEA refused to consider the petition, public hearings were finally held on the matter beginning in 1986. In September 1988, after two years of extensive public hearings, DEA Chief Administrative Law Judge Francis L. Young ruled in favor of moving cannabis to a Schedule II classification, finding that "Marijuana, in its natural form, is one of the safest therapeutically active substances known to man." Young concluded: "The evidence in this record clearly shows that marijuana has been accepted as capable of relieving the distress of great numbers of very ill people, and doing so with safety under medical supervision. It would be unreasonable, arbitrary and capricious for DEA to continue to stand between those sufferers and the benefits of this substance in light of the evidence in this record." As Young's ruling was only a non-binding recommendation, however, it was rejected by DEA Administrator John Lawn in December 1989. In February 1994, a final ruling on the original 1972 petition was issued when a U.S. Court of Appeals upheld the decision to keep cannabis a Schedule I drug.
PrecisionFDA
PrecisionFDA (stylized precisionFDA) is a cloud-based next-generation DNA sequencing (NGS) data platform developed by the United States Food and Drug Administration (FDA). It was designed as part of President Barack Obama's Precision Medicine Initiative in 2015. The platform allows researchers to upload and compare data against reference genomes, bioinformatics pipelines, and genomic data. Users may also use the service to verify their genetic tests against reference genomes. The platform's code is open source and available on GitHub.
Civil defense by country
The Office of Civilian Defense was set up May 20, 1941, by Executive Order 8757, to co-ordinate state and federal measures for protection of civilians in case of war emergency. The Federal Civil Defense Administration (FCDA) was organized on December 1, 1950, and distributed civil defense information until it was merged with FEMA in 1979. Between 1979 and 2001, the duties of Civil Defense were served by the Federal Emergency Management Agency (FEMA). FEMA was absorbed into the Department of Homeland Security in 2003.
Food and Drug Administration Safety and Innovation Act
In response to the GAIN Act, the FDA announced in Sept. 2012 that they were creating The Antibacterial Drug Development Task Force to assist in developing and revising guidance related to antibacterial drug development. The task force consisted of a multi-disciplinary group of 19 CDER scientists and clinicians who were charged with identifying priority areas and developing and implementing possible solutions to the challenges of antibacterial drug development.
Pharmacovigilance
In the U.S., with about a third of all global 2011 pharmaceutical expenditures, the drug industry is regulated by the FDA, the largest national drug regulatory authority in the world. FDA authority is exercised through enforcement of regulations derived from legislation, as published in the U.S. Code of Federal Regulations (CFR); the principal drug safety regulations are found in 21 CFR Part 312 (IND regulations) and 21 CFR Part 314 (NDA regulations). While those regulatory efforts address pre-marketing concerns, pharmaceutical manufacturers and academic/non-profit organizations such as RADAR and Public Citizen do play a role in pharmacovigilance in the US. The post-legislative rule-making process of the U.S. federal government provides for significant input from both the legislative and executive branches, which also play specific, distinct roles in determining FDA policy.
Pesticides in the United States
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was first passed in 1947, giving the United States Department of Agriculture responsibility for regulating pesticides. In 1972, FIFRA underwent a major revision and transferred responsibility of pesticide regulation to the Environmental Protection Agency and shifted emphasis to protection of the environment and public health.
Regulation of food and dietary supplements by the U.S. Food and Drug Administration
The was the first of a series of significant consumer protection laws enacted by the Federal Government in the twentieth century and led to the creation of the Food and Drug Administration. Its main purpose was to ban foreign and interstate traffic in adulterated or mislabeled food and drug products, and it directed the U.S. Bureau of Chemistry to inspect products and refer offenders to prosecutors. It required that active ingredients be placed on the label of a drug’s packaging and that drugs could not fall below purity levels established by The United States Pharmacopeia or The National Formulary. "The Jungle" by Upton Sinclair was an inspirational piece that kept the public's attention on the important issue of unsanitary meat processing plants that later formed the Pure Food and Drug Act.
Criticism of the Food and Drug Administration
However, in 2006, the AABB, America's Blood Centers and American Red Cross recommended to the FDA that the deferral period for men who had sex with other men should be changed to be equivalent with the deferral period for heterosexual's judged to be at risk. The FDA chose to uphold the blood ban. Female sexual partners of MSM (men who have sex with men) are deferred for one year since the last exposure. This is the same policy used for any sexual partner of someone in a high-risk group. The intent of these policies is to ensure that blood is collected from a population that is at low risk for disease, since the tests are not perfect and human error may lead to infected units not being properly discarded. The policy was first put in place in 1985.
In April 2005, the FDA issued a statement asserting that cannabis had no medical value and should not be accepted as a medicine, despite a great deal of research suggesting the opposite. The supporters of medical cannabis legalization criticized the FDA's statement as a politically motivated one instead of one based on solid science. A group of congressmen led by Maurice Hinchey wrote a letter to FDA's commissioner Andrew von Eschenbach, expressing their disapproval of the FDA's statement and pointed out the FDA's rejection of medical cannabis was inconsistent with the findings of the Institute of Medicine, which stated cannabis does have medical benefits. While the FDA has not approved marijuana it has approved THC (a compound found in cannabis) as an active ingredient for medicinal use. Critics argue that this approval is a politically motivated attempt to allow special interest groups to have patents over the substance, perhaps because the patents on previously patented competing substances have expired.
Council of Fashion Designers of America
The Council of Fashion Designers of America, Inc. (CFDA), founded in 1962 by publicist Eleanor Lambert, is a not-for-profit trade association of over 450 American fashion and accessory designers. The first president of the Council was Sydney Wragge (till 1965). As of 2009, Diane von Fürstenberg was the group's president and Steven Kolb the CEO. The organization's stated mission is to strengthen the influence and success of American designers in the global economy.
FDA (trade union)
The FDA, formerly The Association of First Division Civil Servants, is a trade union for UK senior and middle management civil servants and public service professionals founded in 1918.
Quackery
For those in the practice of any medicine, to allege quackery is to level a serious objection to a particular form of practice. Most developed countries have a governmental agency, such as the Food and Drug Administration (FDA) in the US, whose purpose is to monitor and regulate the safety of medications as well as the claims made by the manufacturers of new and existing products, including drugs and nutritional supplements or vitamins. The Federal Trade Commission (FTC) participates in some of these efforts. To better address less regulated products, in 2000, US President Clinton signed Executive Order 13147 that created the White House Commission on Complementary and Alternative Medicine. In 2002, the commission's final report made several suggestions regarding education, research, implementation, and reimbursement as ways to evaluate the risks and benefits of each. As a direct result, more public dollars have been allocated for research into some of these methods.
Food and Drug Administration
The responsibility for examining food and drugs for such "adulteration" or "misbranding" was given to Wiley's USDA Bureau of Chemistry. Wiley used these new regulatory powers to pursue an aggressive campaign against the manufacturers of foods with chemical additives, but the Chemistry Bureau's authority was soon checked by judicial decisions, which narrowly defined the bureau's powers and set high standards for proof of fraudulent intent. In 1927, the Bureau of Chemistry's regulatory powers were reorganized under a new USDA body, the Food, Drug, and Insecticide organization. This name was shortened to the Food and Drug Administration (FDA) three years later.
Federal Health Agency
The Federal Health Agency () was a federal government agency and the central research institution for public health in Germany. It was founded in 1876, named the Imperial Health Agency (). It was succeeded by the Reichsgesundheitsamt in 1918 and by the Bundesgesundheitsamt in 1952 (both meaning Federal Health Agency). The agency was dissolved in 1994, and its responsibilities transferred to three institutions, the Federal Institute for Drugs and Medical Devices, the Robert Koch Institute and the Federal Institute for Health Consumer Protection and Veterinary Medicine.
Economic history of the United States
The Pure Food and Drug Act of 1906 was the first of a series of legislation that led to the establishment of the Food and Drug Administration (FDA). Another such act passed the same year was the Federal Meat Inspection Act. The new laws helped the large packers, and hurt small operations that lacked economy of scale or quality controls.
Bureau of Drug Abuse Control
The Bureau of Drug Abuse Control was formed as a part of the United States Food and Drug Administration in February 1966 and existed until 1968 when it was merged with the Federal Bureau of Narcotics to form the Bureau of Narcotics and Dangerous Drugs. It was later combined with various other agencies to establish the Drug Enforcement Administration on July 1973.
History of the Food and Drug Administration
Most federal laws concerning the FDA are part of the Food, Drug and Cosmetic Act, (first passed in 1938 and extensively amended since) and are codified in Title 21, Chapter 9 of the United States Code. Other significant laws enforced by the FDA include the Public Health Service Act, parts of the Controlled Substances Act, the Federal Anti-Tampering Act, as well as many others. In many cases these responsibilities are shared with other federal agencies.
History of pharmacy in the United States
Hunsberger cites the founding of the Philadelphia College of Pharmacy (PCP) as "the first step forward in the development of a system of pharmaceutical practice in the United States," with the 1821 "meeting of apothecaries...held in Carpenters' Hall" (where the Declaration of Independence had been signed) to set up the first formal college of pharmacy and first pharmacists' association (the Philadelphia College of Pharmacy) in North America the seminal founding event. On March 13, 1821, "Sixty-eight pharmacists signed the Constitution of the first pharmaceutical association in the United States," with the symbolism of the Carpenters' Hall backdrop undeniable: American pharmacy would have a constitution, following in the footsteps of the founding fathers and their constitutional framework. The PCP constitution included a strict code of ethics that would expel anyone from the college who "adulterated" medications or knowingly sold "articles of that character," and provided for a "committee of inspection" to verify the purity, safety and effectiveness of medicines, and a "committee of equity" to arbitrate disputes between member pharmacists.
The college, which was founded as an association to advance the discipline of pharmacy not just a university, quickly became a game-changer: in 1824 they published "carefully determined formulas" for the fabrication of (formerly) "secret-formula" patent medicines previously imported from the UK, an essential step toward self-sufficient pharmaceutical manufacturing in the U.S.
Food and Drug Administration
Concerns about the length of the drug approval process were brought to the fore early in the AIDS epidemic. In the mid- and late 1980s, ACT-UP and other HIV activist organizations accused the FDA of unnecessarily delaying the approval of medications to fight HIV and opportunistic infections. Partly in response to these criticisms, the FDA issued new rules to expedite approval of drugs for life-threatening diseases, and expanded pre-approval access to drugs for patients with limited treatment options. All of the initial drugs approved for the treatment of HIV/AIDS were approved through these accelerated approval mechanisms. Frank Young, the commissioner of the FDA was behind the Action Plan Phase II, established in August 1987 for quicker approval of AIDS medication.
Orphan drug
The Pharmaceitical Executive opines, that the "ODA is nearly universally acknowledged to be a success".
Before the United States Congress enacted the ODA in 1983, only 38 drugs were approved in the USA specifically to treat orphan diseases. 
In the USA, from January 1983 to June 2004, the Office of Orphan Products Development 249 orphan drugs received marketing authorization and granted 1,129 different orphan drug designations, compared to fewer than ten such products in the decade prior to 1983. 
From 1983 until May 2010, the FDA approved 353 orphan drugs and granted orphan designations to 2,116 compounds. 
As of 2010, 200 of the roughly 7,000 officially designated orphan diseases have become treatable.
Food and Drug Administration
Nine FDA scientists appealed to then president-elect Barack Obama over pressures from management, experienced during the George W. Bush presidency, to manipulate data, including in relation to the review process for medical devices. Characterized as "corrupted and distorted by current FDA managers, thereby placing the American people at risk," these concerns were also highlighted in the 2006 report on the agency as well.
Regulation of therapeutic goods
In the United States, regulation of drugs was originally a state right, as opposed to federal right. But with the increase in fraudulent practices due to private incentives to maximize profits and poor enforcement of state laws, increased the need for stronger federal regulation. President Roosevelt signed the Federal Food and Drug Act (FFDA) in 1906 which established stricter standards. A 1911 Supreme Court decision, "United States vs. Johnson", established that misleading statements were not covered under the FFDA. This directly led to Congress passing the Sherley Amendment which established a clearer definition of ‘misbranded’.
Food and Drug Administration
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, in the course of an extensive congressional investigation into the FDA. The oversight subcommitee of the United States House Energy and Commerce Committee resulted from a complaint brought against the FDA by Mylan Laboratories Inc. of Pittsburgh. When its application to manufacture generics were subjected to repeated delays by the FDA, Mylan, convinced that it was being discriminated against, soon began its own private investigation of the agency in 1987. Mylan eventually filed suit against two former FDA employees and four drug-manufacturing companies, charging that corruption within the federal agency resulted in racketeering and in violations of antitrust law. "The order in which new generic drugs were approved was set by the FDA employees even before drug manufacturers submitted applications" and, according to Mylan, this illegal procedure was followed to give preferential treatment to certain companies. During the summer of 1989, three FDA officials (Charles Y. Chang, David J. Brancato, Walter Kletch) pleaded guilty to criminal charges of accepting bribes from generic drugs makers, and two companies (Par Pharmaceutical and its subsidiary Quad Pharmaceuticals) pleaded guilty to giving bribes.
Sertraline
Sertraline was approved by the U.S. Food and Drug Administration (FDA) in 1991 based on the recommendation of the Psychopharmacological Drugs Advisory Committee; it had already become available in the United Kingdom the previous year. The FDA committee achieved a consensus that sertraline was safe and effective for the treatment of MDD.
Jane E. Henney
Jane Ellen Henney (born 1947) is an American physician who was the first woman to serve as commissioner of the U.S. Food and Drug Administration. Appointed by President Bill Clinton, she served at the FDA between 1998 and 2001. She is married to James Robert Graham III, who also has had a distinguished career as a physician-leader.
Parenteral Drug Association
Founded in 1946 as the Parenteral Drug Association by a small group of pharmaceutical manufacturers who recognized the need for an organization to disseminate technical information within the industry, it now has more than 11,000 members worldwide. Today, coordinated through its headquarters and its Training & Research Institute in Bethesda, Maryland, PDA volunteers worldwide promote the exchange of rapidly evolving information on the latest technology and regulations concerning high-quality pharmaceutical production.
Kefauver Harris Amendment
The Kefauver Harris Amendment strengthened the U.S. Food and Drug Administration's control of experimentation on humans and changed the way new drugs are approved and regulated. Before the Thalidomide scandal in Europe, and Canada, U.S. drug companies only had to show their new products were safe. After the passage of the Amendment, an FDA New Drug Application (NDA) would have to show that a new drug was both safe and effective (previously the 1938 Food, Drug and Cosmetic Act was the main law that regulated drug safety). Informed consent was required of patients participating in clinical trials, and adverse drug reactions were required to be reported to the FDA.
Critical Path Institute
To address the declining productivity of the pharmaceutical industry, the U.S. Food and Drug Administration (FDA) launched the Critical Path Initiative (CPI) in 2004, its national strategy for forming collaborations to transform the way FDA-regulated medical products are developed, evaluated, and manufactured. C-Path was created with support and funding from the FDA, Science Foundation Arizona, and the Tucson community. C-Path's creation was designed to fill an essential role as a neutral third party that enables scientists from the regulated industry and international regulatory agencies to work together to establish a faster, safer, and more efficient path through the drug development process.