Editing Food and Drug Administration (section)

====Generic drugs====
Generic drugs are chemical and therapeutic equivalents of [[name-brand]] drugs, normally whose patents have expired.<ref name="TNBK"/> Approved generic drugs should have the same dosage, safety, effectiveness, strength, stability, and quality, as well as route of administration. In general, they are less expensive than their name brand counterparts, are manufactured and marketed by rival companies and, in the 1990s, accounted for about a third of all prescriptions written in the United States.<ref name="TNBK"/> For a pharmaceutical company to gain approval to produce a generic drug, the FDA requires scientific evidence that the generic drug is interchangeable with or therapeutically equivalent to the originally approved drug.<ref name="Therapeutic Equivalance of Generic Drugs">{{cite web |url=https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm073182.htm |title=Therapeutic Equivalence of Generic Drugs |access-date=August 30, 2012 |publisher=Food and Drug Administration |year=1998 |archive-date=April 29, 2012 |archive-url=https://web.archive.org/web/20120429002732/http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm073182.htm |url-status=live}}</ref> This is called an [[Abbreviated New Drug Application]] (ANDA).<ref>{{cite web |title=Abbreviated New Drug Application (ANDA) |date=December 20, 2019 |publisher=U.S. Food & Drug Administration |url=https://www.fda.gov/drugs/types-applications/abbreviated-new-drug-application-anda |access-date=May 10, 2020 |archive-date=September 23, 2020 |archive-url=https://web.archive.org/web/20200923221401/https://www.fda.gov/drugs/types-applications/abbreviated-new-drug-application-anda |url-status=live}}</ref> 80% of prescription drugs sold in the United States are generic brands.<ref>{{cite web | vauthors = Saling J | title=Generic Drugs: Answers to Common Questions | website=WebMD | date=March 5, 2024 | url=https://www.webmd.com/healthy-aging/generic-drugs-answers-to-common-questions | access-date=May 27, 2024 |quote=Almost 80% of prescription drugs sold are generics.}}</ref>

=====Generic drug scandal=====
In 1989, a major scandal erupted involving the procedures used by the FDA to approve generic drugs for sale to the public.<ref name="TNBK">{{cite encyclopedia | vauthors = Cohen L |article=Government Policies and Programs&nbsp;– United States&nbsp;– Generic Drug Scandal |title=The New Book of Knowledge&nbsp;– Medicine And Health |date=1990 |pages=276–281 |isbn=978-0-7172-8244-9}}</ref> Charges of corruption in generic drug approval first emerged in 1988 during the course of an extensive congressional investigation into the FDA. The oversight subcommittee of the [[House Energy and Commerce Committee|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)<ref>{{cite news |url=https://www.nytimes.com/1989/09/12/business/fda-details-problems-at-drug-makers.html |work=The New York Times |title=F.D.A. Details Problems at Drug Makers |date=September 12, 1989 |access-date=February 7, 2017 |archive-date=March 13, 2017 |archive-url=https://web.archive.org/web/20170313215132/http://www.nytimes.com/1989/09/12/business/fda-details-problems-at-drug-makers.html |url-status=live}}</ref> pleaded guilty to giving bribes.

Furthermore, it was discovered that several manufacturers had falsified data submitted in seeking FDA authorization to market certain generic drugs. Vitarine Pharmaceuticals of New York, which sought approval of a generic version of the drug [[Dyazide]], a medication for high blood pressure, submitted Dyazide, rather than its generic version, for the FDA tests. In April 1989, the FDA investigated 11 manufacturers for irregularities; and later brought that number up to 13. Dozens of drugs were eventually suspended or recalled by manufacturers. In the early 1990s, the [[U.S. Securities and Exchange Commission]] filed securities fraud charges against the Bolar Pharmaceutical Company, a major generic manufacturer based in Long Island, New York.<ref name="TNBK"/>