{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T00:09:53Z","timestamp":1777421393874,"version":"3.51.4"},"reference-count":23,"publisher":"SAGE Publications","issue":"12","license":[{"start":{"date-parts":[[2022,5,2]],"date-time":"2022-05-02T00:00:00Z","timestamp":1651449600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ann Pharmacother"],"published-print":{"date-parts":[[2022,12]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>The objective of this study was to describe law enforcement oversight of counterfeit drugs by the Food and Drug Administration (FDA) in the United States from 2016 through 2021.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The FDA Office of Criminal Investigation database with hyperlinked press releases of enforcement actions was used to identify legal action against drug counterfeiters. Incidences of counterfeit drugs sold via Internet, how often they were obtained without a prescription, the most prevalent counterfeit drugs, the countries where counterfeit operations occurred, and the scale of counterfeit operations were assessed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>There were 130 unique enforcement actions against counterfeiting organizations and individuals. Overall, 64.6% of enforcement actions involved counterfeit products sold over the Internet, in 84.6% of actions counterfeit medications could be obtained without a prescription, and in 33.1% of actions the products were sold as dietary supplements. Sexual dysfunction, opioid, stimulant, anabolic muscle building, benzodiazepine, and dermatologic drugs were most counterfeited. China was the most prevalent country to produce counterfeit drugs followed by India, Turkey, Pakistan, and Russia. Counterfeiting operations were large with tens of millions of pills and hundreds of millions of dollars in sales. Health outcomes for counterfeit drugs were rarely discussed in the press releases and not all press releases had data for each parameter of interest.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion and Relevance<\/jats:title>\n                    <jats:p>This is the first report assessing enforcement actions against drug counterfeiters from the FDA Office of Criminal Investigation. The FDA is actively involved in identifying and prosecuting counterfeit drug rings, but the number of enforcement actions is smaller than the size of the problem.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/10600280221092482","type":"journal-article","created":{"date-parts":[[2022,5,3]],"date-time":"2022-05-03T02:13:10Z","timestamp":1651543990000},"page":"1333-1338","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":5,"title":["Criminal Action Against Drug Counterfeiters: Assessment of the FDA Office of Criminal Investigation Database 2016 Through 2021"],"prefix":"10.1177","volume":"56","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9367-4893","authenticated-orcid":false,"given":"C. Michael","family":"White","sequence":"first","affiliation":[{"name":"University of Connecticut School of Pharmacy, Storrs, CT, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2022,5,2]]},"reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1177\/1060028019881692."},{"key":"e_1_3_2_3_2","unstructured":"FDA. About OCI. Accessed January 25 2022. https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/criminal-investigations\/about-oci."},{"key":"e_1_3_2_4_2","unstructured":"Carmichael D. New charges in generic drug scandal. United Press International Archives Published February 1991. Accessed March 4 2022. https:\/\/www.upi.com\/Archives\/1991\/02\/26\/New-charges-in-generic-drug-scandal\/2161667544400\/."},{"key":"e_1_3_2_5_2","unstructured":"FDA. Press Releases. Accessed January 25 2022. https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/criminal-investigations\/press-releases."},{"key":"e_1_3_2_6_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.japh.2020.04.020."},{"key":"e_1_3_2_7_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.biopha.2020.111128."},{"key":"e_1_3_2_8_2","unstructured":"Sildenafil Package Insert. Pfizer Labs NY NY 3\/2014. Accessed November 18 2021. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2014\/20895s039s042lbl.pdf."},{"key":"e_1_3_2_9_2","doi-asserted-by":"publisher","DOI":"10.1177\/1060028019900504."},{"key":"e_1_3_2_10_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jsxm.2016.12.162"},{"key":"e_1_3_2_11_2","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.1860."},{"key":"e_1_3_2_12_2","unstructured":"DEA. Sharp Increase in Fake Prescription Pills Containing Fentanyl and Meth. Published September 2021. Accessed March 4 2022. https:\/\/www.dea.gov\/alert\/sharp-increase-fake-prescription-pills-containing-fentanyl-and-meth."},{"key":"e_1_3_2_13_2","unstructured":"FDA Announcement. FDA Drug Safety Communication: FDA Recommends Against the Continued Use of Meridia (sibutramine). Published October 2010. Accessed January 4 2022. https:\/\/www.fda.gov\/drugs\/drug-safety-and-availability\/fda-drug-safety-communication-fda-recommends-against-continued-use-meridia-sibutramine."},{"key":"e_1_3_2_14_2","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.266."},{"key":"e_1_3_2_15_2","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.742."},{"key":"e_1_3_2_16_2","doi-asserted-by":"publisher","DOI":"10.1007\/s13181-011-0162-6."},{"key":"e_1_3_2_17_2","doi-asserted-by":"publisher","DOI":"10.1161\/01.CIR.0000012126.56352.FD."},{"key":"e_1_3_2_18_2","unstructured":"FDA Announcement. Questions and Answers about FDA\u2019s Initiative Against Contaminated Weight Loss Products. Accessed January 4 2022. https:\/\/www.fda.gov\/drugs\/questions-answers\/questions-and-answers-about-fdas-initiative-against-contaminated-weight-loss-products."},{"key":"e_1_3_2_19_2","doi-asserted-by":"publisher","DOI":"10.2165\/11898640-000000000-00000."},{"key":"e_1_3_2_20_2","unstructured":"National Library of Medicine. Anabolic Steroids. Accessed January 26 2022. https:\/\/medlineplus.gov\/anabolicsteroids.html."},{"key":"e_1_3_2_21_2","doi-asserted-by":"publisher","DOI":"10.2165\/00007256-200232020-00001."},{"key":"e_1_3_2_22_2","doi-asserted-by":"publisher","DOI":"10.7326\/M20-2496."},{"key":"e_1_3_2_23_2","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.1687."},{"key":"e_1_3_2_24_2","unstructured":"FDA. Tainted Products Marketed as Dietary Supplements_CDER. Accessed January 4 2022. https:\/\/www.accessdata.fda.gov\/scripts\/sda\/sdnavigation.cfm?filter=&sortColumn=1a&sd=tainted_supplements_cder&displayAll=false&page=22."}],"container-title":["Annals of Pharmacotherapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/10600280221092482","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/10600280221092482","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/10600280221092482","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T11:16:50Z","timestamp":1777375010000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/10600280221092482"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,5,2]]},"references-count":23,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2022,12]]}},"alternative-id":["10.1177\/10600280221092482"],"URL":"https:\/\/doi.org\/10.1177\/10600280221092482","relation":{},"ISSN":["1060-0280","1542-6270"],"issn-type":[{"value":"1060-0280","type":"print"},{"value":"1542-6270","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,5,2]]}}}