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Research

Repurposing existing drugs for new uses: a cohort study of the frequency of FDA-granted new indication exclusivities since 1997

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Article: 3 | Received 17 Aug 2020, Accepted 01 Dec 2020, Published online: 04 Dec 2023

References

  • Berndt ER, Cockburn IM, Grépin KA. The impact of incremental innovation in biopharmaceuticals. PharmacoEconomics. 2006;24(2):69–86.
  • Zhou Y, Hou Y, Shen J, Huang Y, Martin W, Cheng F. Network-based drug repurposing for novel coronavirus 2019-nCoV/SARS-CoV-2. Cell Discov. 2020;6(1):14.
  • Wang M, Cao R, Zhang L, Yang X, Liu J, Xu M, et al. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell Res. 2020;30(3):269–271.
  • Thorlund K, Mills E, Mehta C. Global coronavirus COVID-19 clinical trial tracker. https://www.covid19-trials.org. 2020. Accessed 20 Jul 2020.
  • Cha Y, Erez T, Reynolds IJ, Kumar D, Ross J, Koytiger G, et al. Drug repurposing from the perspective of pharmaceutical companies. Br J Pharmacol. 2018;175(2):168–180.
  • Stafford RS. Regulating off-label drug use—rethinking the role of the FDA. N Engl J Med. 2008;358(14):1427–1429.
  • Radley DC, Finkelstein SN, Stafford RS. Off-label prescribing among office-based physicians. Arch Intern Med. 2006;166(9):1021–1026.
  • De Souza JA, Polite B, Perkins M, Meropol NJ, Ratain MJ, Newcomer LN, et al. Unsupported off-label chemotherapy in metastatic colon cancer. BMC Health Serv Res. 2012;12(1):481.
  • Paczynski RP, Alexander GC, Chinchilli VM, Kruszewski SP. Quality of evidence in drug compendia supporting off-label use of typical and atypical antipsychotic medications. Int J Risk Saf Med. 2012;24:137–146.
  • McKean A, Monasterio E. Off-label use of atypical antipsychotics. CNS Drugs. 2012;26(5):383–390.
  • Goločorbin-Kon S, Iličković I, Mikov M. Reasons for and frequency of off-label drug use. Med Pregl. 2015;68(1–2):35–40.
  • Gonçalves MG, Heineck I. Frequency of prescriptions of off-label drugs and drugs not approved for pediatric use in primary health care in a southern municipality of Brazil. Revista Paulista de Pediatria. 2016;34(1):11–17.
  • Ferner RE, Aronson JK. Chloroquine and hydroxychloroquine in covid-19. BMJ. 2020;369:m1432. https://doi.org/10.1136/bmj.m1432.
  • Allen HC, Garbe MC, Lees J, Aziz N, Chaaban H, Miller JL, et al. Off-label medication use in children, more common than we think: a systematic review of the literature. J Okla State Med Assoc. 2018;111(8):776–783.
  • Bazzano AT, Mangione-Smith R, Schonlau M, Suttorp MJ, Brook RH. Off-label prescribing to children in the United States outpatient setting. Acad Pediatr. 2009;9(2):81–88.
  • Palmaro A, Bissuel R, Renaud N, Durrieu G, Escourrou B, Oustric S, et al. Off-label prescribing in pediatric outpatients. Pediatrics. 2015;135(1):49–58.
  • Hoon D, Taylor MT, Kapadia P, Gerhard T, Strom BL, Horton DB. Trends in off-label drug use in ambulatory settings: 2006–2015. Pediatrics. 2019;144:4.
  • Federal Food, Dug, and Cosmetic Act 1938 s.505C.3.E and s.505F.J.5 (USA). https://ballotpedia.org/Federal_Food,_Drug,_and_Cosmetic_Act_of_1938. Accessed 1 Feb 2020.
  • Benjamin N. Roin. Solving the Problem of New Uses. Mich. St. L. Rev; 2013. 67 p. https://dash.harvard.edu/handle/1/11189865. Accessed 10 Jul 2020.
  • Eisenberg RS. The problem of new uses. Yale J Health Pol’y L & Ethics. 2005;5:717.
  • Wang B, Liu J, Kesselheim AS. Variations in time of market exclusivity among top-selling prescription drugs in the United States. JAMA Internal Med. 2015;175(4):635–637.
  • Grabowski H, Long G, Mortimer R, Boyo A. Updated trends in US brand-name and generic drug competition. J Med Econ. 2016;19(9):836–844.
  • Approved Drug Products with Therapeutic Equivalence Evaluations. The Orange Book. United States Food and Drug Administration. 2020. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book. Accessed 7 Feb 2020.
  • Drugs@FDA Data Files. Drugs Approvals and Databases. United States Food and Drug Administration. 2020. https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files. Accessed 15 Feb 2020.
  • Richardson E. Off-Label Drug Promotion. Health Affairs. 30 June 2016; doi: https://doi.org/10.1377/hpb20160630.920075
  • Copenhagen Economics. Study on the economic impact of supplementary protection certificates, pharmaceutical incentives and rewards in Europe: Final Report . Publications Office of the European Union. 2018. 386 p.
  • Sarpatwari A, Beall RF, Abdurrob A, He M, Kesselheim AS. Evaluating the impact of the orphan drug act’s seven-year market exclusivity period. Health Aff. 2018;37(5):732–737.
  • Patents and Exclusivity. FDA/CDER SBIA Chronicles. United States Food and Drug Administration. https://www.fda.gov/media/92548/download. Accessed 15 Apr 2020.
  • Sinha MS, Najafzadeh M, Rajasingh EK, Love J, Kesselheim AS. Labeling changes and costs for clinical trials performed under the US Food and Drug Administration pediatric exclusivity extension, 2007 to 2012. JAMA Internal Med. 2018;178(11):1458–1466.
  • Ridley DB, Régnier SA. The commercial market for priority review vouchers. Health Aff. 2016;35(5):776–783.
  • Kesselheim AS. Drug development for neglected diseases—the trouble with FDA review vouchers. N Engl J Med. 2008;359(19):1981–1983.