Editing Food and Drug Administration (section)

==History==
{{Main|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 [[Vaccine Act of 1813]].<ref>{{Cite book | author = ((National Research Council (US) Division of Health Promotion and Disease Prevention)) |url=https://www.ncbi.nlm.nih.gov/books/NBK216821/ |title=Vaccines: Past, Present, and Future |date=1985 |publisher=National Academies Press (US) |language=en |access-date=January 14, 2023 |archive-date=June 27, 2023 |archive-url=https://web.archive.org/web/20230627130317/http://www.ncbi.nlm.nih.gov/books/NBK216821/ |url-status=live }}</ref> The history of the FDA can be traced to the latter part of the 19th century and the Division of Chemistry of the [[U.S. Department of Agriculture]],<ref name="swann06">{{cite journal | vauthors = Swann JP |title=How Chemists Pushed for Consumer Protection: The Food and Drugs Act of 1906 |journal=Chemical Heritage |date=Summer 2006 |volume=24 |issue=2 |pages=6–11 |url=https://www.fda.gov/media/110307/download |access-date=September 17, 2021 |archive-date=September 17, 2021 |archive-url=https://web.archive.org/web/20210917071757/https://www.fda.gov/media/110307/download |url-status=live }}</ref> which [[United States Department of Agriculture#Origins in the Patent Office|itself derived]] from the [[Copyright and Patent Clause]]. Under [[Harvey Washington Wiley]], appointed chief chemist in 1883, the Division began conducting research into the adulteration and misbranding of food and drugs on the American market.<ref name=swann06/> Wiley's advocacy came at a time when the public had become aroused to hazards in the marketplace by [[muckraker|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]].<ref name="FDAHist">{{cite web |url=https://www.fda.gov/AboutFDA/WhatWeDo/History/Origin/ucm054819.htm |title=FDA History&nbsp;— Part I |publisher=Food and Drug Administration |access-date=March 14, 2015 |archive-date=March 16, 2015 |archive-url=https://web.archive.org/web/20150316152305/http://www.fda.gov/AboutFDA/WhatWeDo/History/Origin/ucm054819.htm |url-status=live}}</ref> The [[Biologics Control Act|Biologics Control Act of 1902]] was put in place after a [[diphtheria]] antitoxin derived from tetanus-contaminated serum caused the deaths of thirteen children in St. Louis, Missouri. The serum was originally collected from a horse named [[Jim (horse)|Jim]] who had contracted tetanus.<ref>{{Cite web |last=cirmweb |date=June 4, 2012 |title=The surprising journey from a horse named Jim to stem cell therapies at UC Davis |url=https://blog.cirm.ca.gov/2012/06/04/surprising-journey-from-horse-named-jim/ |access-date=January 14, 2023 |website=The Stem Cellar |language=en |archive-date=January 14, 2023 |archive-url=https://web.archive.org/web/20230114025520/https://blog.cirm.ca.gov/2012/06/04/surprising-journey-from-horse-named-jim/ |url-status=live }}</ref>

[[File:Portrait of Dr. Harvey W. Wiley (FDA 107) (8203830456).jpg|thumb|upright|[[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|Pure Food and Drug Act of 1906]], also known as the "Wiley Act" after its chief advocate.<ref name="FDAHist"/><ref name=swann06/> The Act prohibited, under penalty of seizure of goods, the interstate transport of food that had been "adulterated".<ref name=swann06/> The Act applied similar penalties to the interstate marketing of "adulterated" drugs, in which the "standard of strength, quality, or purity" of the active ingredient was not either stated clearly on the label or listed in the ''[[United States Pharmacopeia]]'' or the ''[[National Formulary]]''.<ref>{{cite web |url=https://www.fda.gov/opacom/laws/wileyact.htm |title=Laws Enforced by FDA | author = Office of the Commissioner |publisher=Food and Drug Administration |access-date=December 16, 2019 |archive-date=May 12, 2009 |archive-url=https://web.archive.org/web/20090512143516/http://www.fda.gov/opacom/laws/wileyact.htm |url-status=live}}</ref><ref name=swann06/>

The responsibility for examining food and drugs for such "adulteration" or "misbranding" was given to Wiley's USDA Bureau of Chemistry.<ref name="FDAHist"/> 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.<ref name="FDAHist"/> In 1927, the Bureau of Chemistry's regulatory powers were reorganized under a new USDA body, the Food, Drug, and Insecticide Administration.<ref>{{Cite web |date=March 14, 2019 |title=History of FDA's Internal Organization |url=https://www.fda.gov/about-fda/history-fdas-fight-consumer-protection-and-public-health/history-fdas-internal-organization |access-date=October 3, 2020 |website=U.S. Food and Drug Administration |language=en |archive-date=September 24, 2020 |archive-url=https://web.archive.org/web/20200924220535/https://www.fda.gov/about-fda/history-fdas-fight-consumer-protection-and-public-health/history-fdas-internal-organization |url-status=live }}</ref> This name was shortened to the Food and Drug Administration (FDA) three years later.<ref name="milestones">{{cite web |url=https://www.fda.gov/opacom/backgrounders/miles.html |title=Milestones in U.S. Food and Drug Law History |website=Food and Drug Administration |access-date=December 16, 2019 |archive-date=May 21, 2009 |archive-url=https://web.archive.org/web/20090521181634/http://www.fda.gov/opacom/backgrounders/miles.html |url-status=live}}</ref>

By the 1930s, [[Muckraker|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]], mascara that could cause blindness, and worthless "cures" for [[diabetes]] and [[tuberculosis]].<ref name=swann06/> The resulting proposed law did not 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|Elixir Sulfanilamide]] tragedy, in which over 100 people died after using a drug formulated with a toxic, untested solvent.<ref>{{cite journal | vauthors = Hamowy R |title=Medical Disasters and the Growth of FDA |date=February 2010 |page=7 |journal=Independent Policy Reports |url=http://www.independent.org/pdf/policy_reports/2010-02-10-fda.pdf |access-date=January 14, 2022 |archive-date=October 10, 2011 |archive-url=https://web.archive.org/web/20111010101720/http://independent.org/pdf/policy_reports/2010-02-10-fda.pdf |url-status=live}}</ref>

President [[Franklin Delano Roosevelt]] signed the [[Federal Food, Drug, and Cosmetic Act]] into law on June 24, 1938. The new law significantly increased federal regulatory authority over drugs by mandating a pre-market review of the safety of all new drugs, as well as banning false therapeutic claims in drug labeling without requiring that the FDA prove [[fraudulent intent]].<ref name=swann06/> The law also authorized the FDA to issue minimum [[Standards of identity for food|food standards of identity]] for all mass-produced foods to reduce food fraud.<ref>{{Cite journal | vauthors = Frohlich X |date=March 2022 |title=Making Food Standard: The U.S. Food and Drug Administration's Food Standards of Identity, 1930s–1960s |url=https://www.cambridge.org/core/journals/business-history-review/article/abs/making-food-standard-the-us-food-and-drug-administrations-food-standards-of-identity-1930s1960s/367324CEA5135BFCD1CF1B0E24496F78 |journal=Business History Review |language=en |volume=96 |issue=1 |pages=145–176 |doi=10.1017/S0007680521000726 |issn=0007-6805}}</ref>

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 drug|prescription-only]]" drugs was securely codified into law by the [[Durham-Humphrey Amendment]] in 1951. These developments confirmed extensive powers for the FDA to enforce post-marketing recalls of ineffective drugs.<ref name="FDAHist"/>

[[File:Examining New Drug Applications (067) (7184535293).jpg|thumb|upright|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.]]

Outside of the US, the drug [[thalidomide]] was marketed for the relief of general nausea and [[morning sickness]], but caused birth defects and even the death of thousands of babies when taken during pregnancy.<ref>{{cite web | url = http://www.library.arizona.edu/exhibits/udall/congrept/87th/620817.html | title = Report of Congressman Morris Udall on thalidomide and the Kefauver hearings | publisher = University of Arizona Library | archive-url = https://web.archive.org/web/20100729124333/http://www.library.arizona.edu/exhibits/udall/congrept/87th/620817.html | archive-date=July 29, 2010 }}</ref> American mothers were largely unaffected as [[Frances Oldham Kelsey]] of the FDA refused to authorize the medication for market. In 1962, the [[Kefauver-Harris Amendment]] to the FD&C Act was passed, which represented a "revolution" in FDA regulatory authority.<ref>{{cite journal | vauthors = Temple R | title = Policy developments in regulatory approval | journal = Statistics in Medicine | volume = 21 | issue = 19 | pages = 2939–2948 | date = October 2002 | pmid = 12325110 | doi = 10.1002/sim.1298 | url = https://zenodo.org/record/1229361 | access-date = June 19, 2019 | url-status = live | s2cid = 24779317 | archive-url = https://web.archive.org/web/20181127125144/https://zenodo.org/record/1229361 | archive-date = November 27, 2018 }}</ref> 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.<ref name="'70s 180">{{Cite book |title=How We Got Here: The '70s | vauthors = Frum D |author-link=David Frum |year=2000 |publisher=Basic Books |location=New York, New York |isbn=978-0-465-04195-4 |page=[https://archive.org/details/howwegothere70sd00frum/page/180 180] |url=https://archive.org/details/howwegothere70sd00frum/page/180}}</ref> 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 [[pharmacokinetics|pharmacokinetic]] properties ("bioequivalence") as the corresponding brand-name drug. This Act has been credited with, in essence, creating the modern generic drug industry.<ref name="HatchWaxman">{{cite journal | vauthors = Karki L |year=2005 |title=Review of FDA Law Related to Pharmaceuticals: The Hatch-Waxman Act, Regulatory Amendments and Implications for Drug Patent Enforcement |journal=Journal of the Patent & Trademark Office Society |volume=87 |pages=602–620}}</ref>

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.<ref>{{cite web |url=http://www.actupny.org/documents/cron-88.html |title=ACT UP/NY Chronology 1988 |access-date=March 14, 2015 |archive-date=February 2, 1998 |archive-url=https://web.archive.org/web/19980202195639/http://www.actupny.org/documents/cron-88.html |url-status=live}}</ref> 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.<ref>{{cite web |url=https://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/SpeedingAccesstoImportantNewTherapies/ucm181838.htm |title=FDA Website: Expanded Access and Expedited Approval of New Therapies Related to HIV/AIDS |website=Food and Drug Administration |archive-date=November 1, 2013 |archive-url=https://web.archive.org/web/20131101115339/https://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/SpeedingAccesstoImportantNewTherapies/ucm181838.htm}}</ref> All of the initial drugs approved for the treatment of HIV/AIDS were approved through these accelerated approval mechanisms.<ref>{{cite web |url=https://www.fda.gov/fdac/special/newdrug/speeding.html |title=FDA report on accelerated approval process |website=Food and Drug Administration |archive-date=May 25, 2009 |archive-url=https://web.archive.org/web/20090525082655/https://www.fda.gov/fdac/special/newdrug/speeding.html}}</ref> Frank Young, then commissioner of the FDA, was behind the Action Plan Phase II, established in August 1987 for quicker approval of AIDS medication.<ref>{{Cite journal |title=Reagan, Regulation, and the FDA: The US Food and Drug Administration's Response to HIV/AIDS, 1980–90 | vauthors = Richert L |date=2009 |journal=Canadian Journal of History |volume=44 |issue=3 |pages=467–488 |doi=10.3138/cjh.44.3.467}}</ref>

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|date=June 2014}} 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 ineffective.<ref>{{cite web |url=https://www.npr.org/templates/transcript/transcript.php?storyId=127773447 |title=Medicinal Marijuana: A Patient-Driven Phenomenon |date=June 14, 2010 |work=NPR.org |access-date=March 14, 2015 |archive-date=March 17, 2015 |archive-url=https://web.archive.org/web/20150317084419/http://www.npr.org/templates/transcript/transcript.php?storyId=127773447 |url-status=live}}</ref><ref name="quack-laetrile">{{cite web |url=http://www.quackwatch.com/01QuackeryRelatedTopics/Cancer/laetrile.html |title=The Rise and Fall of Laetrile |access-date=March 14, 2015 |archive-date=July 19, 2018 |archive-url=https://web.archive.org/web/20180719022002/http://www.quackwatch.com/01QuackeryRelatedTopics/Cancer/laetrile.html |url-status=live}}</ref> The second wave concerned [[medical marijuana]] in the 1990s and 2000s. Though [[Cannabis in Virginia|Virginia passed legislation]] allowing doctors to recommend cannabis for glaucoma or the side effects of chemotherapy, a more widespread trend began in California with the [[1996 California Proposition 215|Compassionate Use Act of 1996]].

When the FDA requested [[Endo Pharmaceuticals]] on June 8, 2017, to remove ''[[oxymorphone hydrochloride]]'' from the market, it was the first request in FDA history to recall an effective drug over its potential for misuse.<ref>{{cite press release |date=June 8, 2017 |url=https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm562401.htm |title=FDA requests removal of Opana ER for risks related to abuse |publisher=Food and Drug Administration |access-date=October 26, 2017 |quote=Today, the U.S. Food and Drug Administration requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market... This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse...[FDA Commissioner Scott Gottlieb, M.D.]: "We are facing an opioid epidemic – a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse. |archive-date=November 4, 2017 |archive-url=https://web.archive.org/web/20171104114609/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm562401.htm |url-status=live}}</ref>

In February 2025, FDA food division head Jim Jones quit in protest of the "indiscriminate" layoffs of 89 staff members by the [[Second presidency of Donald Trump|Donald Trump administration]].<ref name="guard-18feb2025">{{cite news |last1=Gedeon |first1=Joseph |title=Food head at FDA quits citing Trump administration's mass staff cuts |url=https://www.theguardian.com/us-news/2025/feb/18/fda-food-head-quits-trump |access-date=February 18, 2025 |work=[[The Guardian]] |date=February 18, 2025}}</ref>