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Veterinary products [ edit ]

The Center for Veterinary Medicine (CVM) is the branch of the FDA that regulates food additives and drugs that are given to animals. [45] CVM does not regulate vaccines for animals; these are handled by the United States Department of Agriculture . [ citation needed ]

CVM's primary focus is on medications that are used in food animals and ensuring that they do not affect the human food supply. The FDA's requirements to prevent the spread of bovine spongiform encephalopathy are also administered by CVM through inspections of feed manufacturers. [ citation needed ]

Tobacco products [ edit ]

Since the Family Smoking Prevention and Tobacco Control Act became law in 2009, the FDA also has had the authority to regulate tobacco products . [46]

In 2009, Congress passed a law requiring color warnings on cigarette packages and on printed advertising, in addition to text warnings from the U.S. Surgeon General. [47]

The nine new graphic warning labels were announced by the FDA in June 2011 and were scheduled to be required to appear on packaging by September 2012. The implementation date is uncertain, due to ongoing proceedings in the case of R.J. Reynolds Tobacco Co. v. U.S. Food and Drug Administration. [48] R.J. Reynolds , Lorillard , Commonwealth Brands Inc. , Liggett Group LLC and Santa Fe Natural Tobacco Company Inc. have filed suit in Washington, D.C. federal court claiming that the graphic labels are an unconstitutional way of forcing tobacco companies to engage in anti-smoking advocacy on the government's behalf. [49]

A First Amendment lawyer, Floyd Abrams , is representing the tobacco companies in the case, contending requiring graphic warning labels on a lawful product cannot withstand constitutional scrutiny. [50] The Association of National Advertisers and the American Advertising Federation have also filed a brief in the suit, arguing that the labels infringe on commercial free speech and could lead to further government intrusion if left unchallenged. [51] In November 2011, Federal judge Richard Leon of the U.S. District Court for the District of Columbia temporarily halted the new labels, likely delaying the requirement that tobacco companies display the labels. The U.S. Supreme Court ultimately could decide the matter. [52]

In July 2017, the FDA announced a plan that would reduce the current levels of nicotine permitted in tobacco cigarettes. [53]

Regulation of living organisms [ edit ]

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

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

The FDA also requires milk to be pasteurized to remove bacteria .

Science and research programs [ edit ]

In addition to its regulatory functions, the FDA carries out research and development activities to develop technology and standards that support its regulatory role, with the objective of resolving scientific and technical challenges before they become impediments. The FDA's research efforts include the areas of biologics, medical devices, drugs, women's health, toxicology, food safety and applied nutrition, and veterinary medicine. [54]

Data management [ edit ]

The FDA has collected a large amount of data through decades. In March 2013, OpenFDA was created to enable easy access of the data for the public.

History [ edit ]

Main article: 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 . 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 its 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. 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 . [55] The 1902 Biologics Control Act was put in place after a diphtheria antitoxin—derived from tetanus-contaminated serum—was used to produce a vaccine that caused the deaths of thirteen children in St. Louis, Missouri. The serum was originally collected from a horse named Jim , who had contracted tetanus.

Harvey W. Wiley , chief advocate of the Food and Drug Act

In June 1906, President Theodore Roosevelt signed into law the Pure Food and Drug Act , also known as the "Wiley Act" after its chief advocate. [55] The Act prohibited, under penalty of seizure of goods, the interstate transport of food that had been "adulterated". The act applied similar penalties to the interstate marketing of "adulterated" drugs, in which the "standard of strength, quality, or purity" of the active ingredient was not either stated clearly on the label or listed in the United States Pharmacopoeia or the National Formulary. [56]

The responsibility for examining food and drugs for such "adulteration" or "misbranding" was given to Wiley's USDA Bureau of Chemistry. [55] 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. [55] 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. [57]

By the 1930s, muckraking journalists, consumer protection organizations, and federal regulators began mounting a campaign for stronger regulatory authority by publicizing a list of injurious products that had been ruled permissible under the 1906 law, including radioactive beverages , the mascara Lash lure, which caused blindness, and worthless "cures" for diabetes and tuberculosis . The resulting proposed law was unable to get through the Congress of the United States for five years, but was rapidly enacted into law following the public outcry over the 1937 Elixir Sulfanilamide tragedy, in which over 100 people died after using a drug formulated with a toxic, untested solvent. [58]

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. [55]

Medical Officer Alexander Fleming, M. D., examines a portion of a 240-volume new drug application around the late 1980s. Applications grew considerably after the efficacy mandate under the 1962 Drug Amendments.

In 1959, the thalidomide tragedy, in which thousands of European babies were born deformed after their mothers took that drug – marketed for treatment of nausea – during their pregnancies, [59] Considering the US was largely spared that tragedy because Dr. Frances Oldham Kelsey of the FDA refused to authorize the medication for market, the 1962 Kefauver-Harris Amendment to the FD&C Act was passed, which represented a "revolution" in FDA regulatory authority. [60] The most important change was the requirement that all new drug applications demonstrate "substantial evidence" of the drug's efficacy for a marketed indication, in addition to the existing requirement for pre-marketing demonstration of safety. This marked the start of the FDA approval process in its modern form.

These reforms had the effect of increasing the time, and the difficulty, required to bring a drug to market. [61] 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. [62]

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. [63] 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. [64] All of the initial drugs approved for the treatment of HIV/AIDS were approved through these accelerated approval mechanisms. [65] Frank Young, the commissioner of the FDA was behind the Action Plan Phase II, established in August 1987 for quicker approval of AIDS medication. [66]

In two instances, state governments have sought to legalize drugs that the FDA has not approved. Under the theory that federal law passed pursuant to Constitutional authority overrules conflicting state laws, federal authorities still claim the authority to seize, arrest, and prosecute for possession and sales of these substances, [ citation needed ] even in states where they are legal under state law. The first wave was the legalization by 27 states of laetrile in the late 1970s. This drug was used as a treatment for cancer, but scientific studies both before and after this legislative trend found it to be ineffective. [67] [68] The second wave concerned medical marijuana in the 1990s and 2000s. Though Virginia passed a law with limited effect in 1979, a more widespread trend began in California in 1996.

Historical first: FDA and Endo Pharmaceutical's Opana ER (2017) [ edit ]

When the FDA requested Endo Pharmaceuticals on June 8, 2017 to remove oxymorphone hydrochloride from the market, it was the first such request in FDA history. [69]

21st century reforms [ edit ]

Critical Path Initiative [ edit ]

The Critical Path Initiative [70] is FDA's effort to stimulate and facilitate a national effort to modernize the sciences through which FDA-regulated products are developed, evaluated, and manufactured. The Initiative was launched in March 2004, with the release of a report entitled Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products. [71]

Patients' rights to access unapproved drugs [ edit ]

The Compassionate Investigational New Drug program was created after Randall v. U.S. ruled in favor of Robert C. Randall in 1978, creating a program for medical marijuana . [72]

A 2006 court case, Abigail Alliance v. von Eschenbach , would have forced radical changes in FDA regulation of unapproved drugs. The Abigail Alliance argued that the FDA must license drugs for use by terminally ill patients with "desperate diagnoses," after they have completed Phase I testing. [73] The case won an initial appeal in May 2006, but that decision was reversed by a March 2007 rehearing. The US Supreme Court declined to hear the case, and the final decision denied the existence of a right to unapproved medications.

Critics of the FDA's regulatory power argue that the FDA takes too long to approve drugs that might ease pain and human suffering faster if brought to market sooner. The AIDS crisis created some political efforts to streamline the approval process. However, these limited reforms were targeted for AIDS drugs, not for the broader market. This has led to the call for more robust and enduring reforms that would allow patients, under the care of their doctors, access to drugs that have passed the first round of clinical trials. [74] [75]

Post-marketing drug safety monitoring [ edit ]

The widely publicized recall of Vioxx , a non-steroidal anti-inflammatory drug now estimated to have contributed to fatal heart attacks in thousands of Americans, played a strong role in driving a new wave of safety reforms at both the FDA rulemaking and statutory levels. Vioxx was approved by the FDA in 1999, and was initially hoped to be safer than previous NSAIDs, due to its reduced risk of intestinal tract bleeding. However, a number of pre- and post-marketing studies suggested that Vioxx might increase the risk of myocardial infarction, and this was conclusively demonstrated by results from the APPROVe trial in 2004. [76]

Faced with numerous lawsuits, the manufacturer voluntarily withdrew it from the market. The example of Vioxx has been prominent in an ongoing debate over whether new drugs should be evaluated on the basis of their absolute safety, or their safety relative to existing treatments for a given condition. In the wake of the Vioxx recall, there were widespread calls by major newspapers, medical journals, consumer advocacy organizations, lawmakers, and FDA officials [77] for reforms in the FDA's procedures for pre- and post- market drug safety regulation.

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. [78] [79] Some of the committee's recommendations have been incorporated into drafts of the PDUFA IV bill, which was signed into law in 2007. [80]

As of 2011, Risk Minimization Action Plans (RiskMAPS) have been created to ensure risks of a drug never outweigh the benefits of that drug within the postmarketing period. This program requires that manufacturers design and implement periodic assessments of their programs' effectiveness. The Risk Minimization Action Plans are set in place depending on the overall level of risk a prescription drug is likely to pose to the public. [81]

Pediatric drug testing [ edit ]

Prior to the 1990s, only 20% of all drugs prescribed for children in the United States were tested for safety or efficacy in a pediatric population. This became a major concern of pediatricians as evidence accumulated that the physiological response of children to many drugs differed significantly from those drugs' effects on adults. Children react different to the drugs because of many reason, including size, weight, etc. There were several reasons that not many medical trials were done with children. For many drugs, children represented such a small proportion of the potential market, that drug manufacturers did not see such testing as cost-effective. [82]

Also, because children were thought to be ethically restricted in their ability to give informed consent , there were increased governmental and institutional hurdles to approval of these clinical trials, as well as greater concerns about legal liability . Thus, for decades, most medicines prescribed to children in the U.S. were done so in a non-FDA-approved, "off-label" manner, with dosages "extrapolated" from adult data through body weight and body-surface-area calculations. [82]

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. [82]

While this debate was unfolding, Congress used the 1997 Food and Drug Administration Modernization Act to pass incentives that gave pharmaceutical manufacturers a six-month patent term extension on new drugs submitted with pediatric trial data. The act reauthorizing these provisions, the 2002 Best Pharmaceuticals for Children Act , allowed the FDA to request NIH-sponsored testing for pediatric drug testing, although these requests are subject to NIH funding constraints. In the Pediatric Research Equity Act of 2003, Congress codified the FDA's authority to mandate manufacturer-sponsored pediatric drug trials for certain drugs as a "last resort" if incentives and publicly funded mechanisms proved inadequate. [82]

Priority review voucher (PRV) [ edit ]

The priority review voucher is a provision of the Food and Drug Administration Amendments Act (HR 3580) signed by President George W. Bush signed the bill in September 2007 which awards a transferable "priority review voucher" to any company that obtains approval for a treatment for a neglected tropical diseases . The system was first proposed by Duke University faculty David Ridley, Henry Grabowski, and Jeffrey Moe in their 2006 Health Affairs paper: "Developing Drugs for Developing Countries". [83] In 2012, President Obama signed into law the FDA Safety and Innovation Act which includes Section 908 the "Rare Pediatric Disease Priority Review Voucher Incentive Program". [84]

Rules for generic biologics [ edit ]

Since the 1990s, many successful new drugs for the treatment of cancer , autoimmune diseases , and other conditions have been protein -based biotechnology drugs , regulated by the Center for Biologics Evaluation and Research . Many of these drugs are extremely expensive; for example, the anti-cancer drug Avastin costs $55,000 for a year of treatment, while the enzyme replacement therapy drug Cerezyme costs $200,000 per year, and must be taken by Gaucher's Disease patients for life. [85]

Biotechnology drugs do not have the simple, readily verifiable chemical structures of conventional drugs, and are produced through complex, often proprietary techniques, such as transgenic mammalian cell cultures. Because of these complexities, the 1984 Hatch-Waxman Act did not include biologics in the Abbreviated New Drug Application (ANDA) process, in essence precluding the possibility of generic drug competition for biotechnology drugs. In February 2007, identical bills were introduced into the House to create an ANDA process for the approval of generic biologics, but were not passed. [85]

Mobile medical applications [ edit ]

In 2013, a guidance was issued to regulate mobile medical applications and protect users from their unintended use. This guidance distinguishes the apps subjected to regulation based on the marketing claims of the apps. [86] Incorporation of the guidelines during the development phase of such app has been proposed for expedite market entry and clearance. [87]

Criticisms [ edit ]

Main article: Criticism of the Food and Drug Administration Wikinews has related news: Obama calls food safety system a 'hazard to public health'

The FDA has regulatory oversight over a large array of products that affect the health and life of American citizens. [55] As a result, the FDA's powers and decisions are carefully monitored by several governmental and non-governmental organizations. A $1.8 million 2006 Institute of Medicine report on pharmaceutical regulation in the U.S. found major deficiencies in the current FDA system for ensuring the safety of drugs on the American market. Overall, the authors called for an increase in the regulatory powers , funding, and independence of the FDA. [88] [89]

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 [88] on the agency as well. [90]

The FDA has also been criticized from the opposite viewpoint, as being too tough on industry. According to an analysis published on the website of the libertarian Mercatus Center as well as published statements by economists, medical practitioners, and concerned consumers, many feel the FDA oversteps its regulatory powers and undermines small business and small farms in favor of large corporations. Three of the FDA restrictions under analysis are the permitting of new drugs and devices, the control of manufacturer speech, and the imposition of prescription requirements. The authors argue that in the increasingly complex and diverse food marketplace, the FDA is not equipped to adequately regulate or inspect food. [91] [ verification needed ] In addition, excessive regulation is blamed for the rising costs of health care and the creation of monopolies , as potential competitors are unable to get FDA approval to enter the market to compete and keep health care costs down. [92]

However, in an indicator that the FDA may be too lax in their approval process, in particular for medical devices, a 2011 study by Dr. Diana Zuckerman and Paul Brown of the National Research Center for Women and Families , and Dr. Steven Nissen of the Cleveland Clinic , published in the Archives of Internal Medicine, showed that most medical devices recalled in the last five years for "serious health problems or death" had been previously approved by the FDA using the less stringent, and cheaper, 510(k) process. In a few cases the devices had been deemed so low-risk that they did not need FDA regulation. Of the 113 devices recalled, 35 were for cardiovascular health purposes. [93]

See also [ edit ]

Ethics portal Food portal Government of the United States portal Health and fitness portal Law portal Medicine portal Drug Efficacy Study Implementation Food and Drug Administration Modernization Act 1997 FDA Food Safety Modernization Act 2011 FDA Fast Track Development Program (for drugs) Food and Drug Administration Amendments Act of 2007 (e.g. drugs) Food and Drug Administration Safety and Innovation Act 2012 (GAIN/QIDP etc.) Inverse benefit law Investigational Device Exemption (for use in clinical trials) Kefauver Harris Amendment 1962 – required "proof-of-efficacy" for drugs


Adverse reaction Adverse event Adverse drug reaction


Food Administration International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Brazil: National Health Surveillance Agency Canada: Marketed Health Products Directorate Canada: Health Canada Denmark: Danish Medicines Agency European Union: European Medicines Agency Germany: Federal Institute for Drugs and Medical Devices India: Food Safety and Standards Authority of India India: Central Drugs Standard Control Organization Japan: Ministry of Health, Labour and Welfare (MHLW) Japan: Pharmaceuticals and Medical Devices Agency Mexico: Federal Commission for the Protection against Sanitary Risk United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration

References [ edit ]

^ "FDA Centennial 1906–2006" . US FDA . Retrieved September 13, 2008 .   ^ Partnership for Public Service (November 2012), The state of the FDA workforce (PDF) , Washington, DC: Author , retrieved May 12, 2017   ^ a b c "FDA Overview" (PDF) . U.S Food and Drug Administration . Retrieved August 30, 2012 .   ^ "Animal Food & Feeds" . U.S Food and Drug Administration . Retrieved March 14, 2015 .   ^ Knezev, Sasha (2016). "Interview with Sidney Wolfe". The Big Lie: American Addict 2 .   |access-date= requires |url= ( help ) ^ "Prescription drug user fee act" . . U.S Food and Drug Administration . Retrieved February 20, 2017 .   ^ McGinley, Laurie (May 9, 2017). "Scott Gottlieb confirmed to lead Food and Drug Administration" . Retrieved May 15, 2017 .   ^ a b "White Oak Campus Information" . U.S. Food and Drug Administration. February 9, 2011 . Retrieved May 12, 2017 .   ^ "FDA's International Posts: Improving the Safety of Imported Food and Medical Products" . U.S Food and Drug Administration . Retrieved April 10, 2010 .   ^ "About the FDA Organization Charts" . U.S Food and Drug Administration. August 29, 2014 . Retrieved July 19, 2015 . FDA is an agency within the Department of Health and Human Services and consists of nine Centers and Offices, which are listed on the menu to the left.   ^ "Office of Operations Organization" . Organization Charts . U.S Food and Drug Administration. April 15, 2015 . Retrieved July 19, 2015 .   ^ "Providing Easy Public Access to Prescription Drug, Over-the-Counter Drug, and Biological Product Labeling" . FDA Voice (blog). August 18, 2014. footer . Retrieved July 19, 2015 .   ^ Taylor, Nick Paul (March 10, 2014). "FDA informatics chief: NGS is an immediate priority for the agency" . Regulatory. FierceBiotechIT . Retrieved July 19, 2015 .   ^ Coordinates of FDA Headquarters at White Oak, Maryland: 39°02′07″N 76°58′59″W  /  39.0353363°N 76.9830894°W  / 39.0353363; -76.9830894  ( FDA Headquarters at White Oak, Maryland ) ^ Meyer, Eugene L. (February 24, 2009). "F.D.A. Consolidates at Former Navy Site" . . Retrieved May 11, 2014 .   ^ "White Oak Campus Project Schedule" . October 8, 2015.   ^ a b Gardiner Harris (November 2, 2008). "The Safety Gap" . New York Times Magazine .   ^ a b Wright, Rob (October 2013). "Drug Take-Back Programs – Coming To A Municipality Near You".