메뉴 건너뛰기




Volumn 37, Issue 5, 2018, Pages 732-737

Evaluating the impact of the Orphan Drug Act's seven-year market exclusivity period

Author keywords

[No Author keywords available]

Indexed keywords

GENERIC DRUG; NEW DRUG; ORPHAN DRUG;

EID: 85046795968     PISSN: 02782715     EISSN: 15445208     Source Type: Journal    
DOI: 10.1377/hlthaff.2017.1179     Document Type: Article
Times cited : (40)

References (31)
  • 1
    • 85046749459 scopus 로고    scopus 로고
    • Silver Spring (MD): FDA [last updated 2017 Dec 18; cited 2018 Feb 26] [Internet]
    • Food and Drug Administration. Funding for rare diseases and pediatric device consortia [Internet]. Silver Spring (MD): FDA; [last updated 2017 Dec 18; cited 2018 Feb 26]. Available from: https://www .fda.gov/ScienceResearch/Funding forRareDiseases
    • Funding for rare diseases and pediatric device consortia
  • 2
    • 84986581698 scopus 로고    scopus 로고
    • History of orphan drug regulation-United States and beyond
    • Haffner ME. History of orphan drug regulation-United States and beyond. Clin Pharmacol Ther. 2016; 100(4):342-3
    • (2016) Clin Pharmacol Ther , vol.100 , Issue.4 , pp. 342-343
    • Haffner, M.E.1
  • 3
    • 80053219051 scopus 로고    scopus 로고
    • An empirical review of major legislation affecting drug development: past experiences, effects, and unintended consequences
    • Kesselheim AS. An empirical review of major legislation affecting drug development: past experiences, effects, and unintended consequences. Milbank Q. 2011;89(3):450-502
    • (2011) Milbank Q , vol.89 , Issue.3 , pp. 450-502
    • Kesselheim, A.S.1
  • 4
    • 79951668738 scopus 로고    scopus 로고
    • The benefits from giving makers of conventional "small molecule" drugs longer exclusivity over clinical trial data
    • Goldman DP, Lakdawalla DN, Malkin JD, Romley J, Philipson T. The benefits from giving makers of conventional "small molecule" drugs longer exclusivity over clinical trial data. Health Aff (Millwood). 2011; 30(1):84-90
    • (2011) Health Aff (Millwood) , vol.30 , Issue.1 , pp. 84-90
    • Goldman, D.P.1    Lakdawalla, D.N.2    Malkin, J.D.3    Romley, J.4    Philipson, T.5
  • 5
    • 85046774302 scopus 로고    scopus 로고
    • Press release, Hatch introduces bill to incentivize development of treatment for rare diseases; 2017 Jul 3 [cited 2018 Feb 26]
    • US Senate [Internet]. Washington (DC): US Senate; 2017. Press release, Hatch introduces bill to incentivize development of treatment for rare diseases; 2017 Jul 3 [cited 2018 Feb 26]. Available from: https://www .hatch.senate.gov/public/index .cfm/releases?ID=18829FAB-B953-4EEE-BE38-976C89F60B70
  • 6
    • 70449686823 scopus 로고    scopus 로고
    • Balancing innovation, access, and profits-market exclusivity for biologics
    • Engelberg AB, KesselheimAS, Avorn J. Balancing innovation, access, and profits-market exclusivity for biologics. N Engl J Med. 2009;361(20): 1917-9
    • (2009) N Engl J Med , vol.361 , Issue.20 , pp. 1917-1919
    • Engelberg, A.B.1    Kesselheim, A.S.2    Avorn, J.3
  • 7
    • 84944518168 scopus 로고    scopus 로고
    • The Trans-Pacific Partnership agreement and implications for access to essential medicines
    • Luo J, Kesselheim AS. The Trans-Pacific Partnership agreement and implications for access to essential medicines. JAMA. 2015;314(15): 1563-4
    • (2015) JAMA , vol.314 , Issue.15 , pp. 1563-1564
    • Luo, J.1    Kesselheim, A.S.2
  • 8
    • 84858112010 scopus 로고    scopus 로고
    • Evergreening, patent challenges, and effective market life in pharmaceuticals
    • Hemphill CS, Sampat BN. Evergreening, patent challenges, and effective market life in pharmaceuticals. J Health Econ. 2012;31(2):327-39
    • (2012) J Health Econ , vol.31 , Issue.2 , pp. 327-339
    • Hemphill, C.S.1    Sampat, B.N.2
  • 9
    • 84870850733 scopus 로고    scopus 로고
    • Polymorphs and prodrugs and salts (oh my!): an empirical analysis of "secondary" pharmaceutical patents
    • Kapczynski A, Park C, Sampat B. Polymorphs and prodrugs and salts (oh my!): an empirical analysis of "secondary" pharmaceutical patents. PLoS One. 2012;7(12):e49470
    • (2012) PLoS One , vol.7 , Issue.12
    • Kapczynski, A.1    Park, C.2    Sampat, B.3
  • 11
    • 84864709156 scopus 로고    scopus 로고
    • Use patents, carve-outs, and incentives-a new battle in the drugpatent wars
    • Rai A. Use patents, carve-outs, and incentives-a new battle in the drugpatent wars. N Engl J Med. 2012; 367(6):491-3
    • (2012) N Engl J Med , vol.367 , Issue.6 , pp. 491-493
    • Rai, A.1
  • 12
    • 84875420198 scopus 로고    scopus 로고
    • Intellectual property Drug patents at the Supreme Court
    • Hemphill CS, Sampat B. Intellectual property. Drug patents at the Supreme Court. Science. 2013; 339(6126):1386-7
    • (2013) Science , vol.339 , Issue.6126 , pp. 1386-1387
    • Hemphill, C.S.1    Sampat, B.2
  • 13
    • 84931457499 scopus 로고    scopus 로고
    • Progress and hurdles for followon biologics
    • Sarpatwari A, Avorn J, Kesselheim AS. Progress and hurdles for followon biologics. N Engl J Med. 2015; 372(25):2380-2
    • (2015) N Engl J Med , vol.372 , Issue.25 , pp. 2380-2382
    • Sarpatwari, A.1    Avorn, J.2    Kesselheim, A.S.3
  • 15
    • 85046709417 scopus 로고    scopus 로고
    • To access the appendix, click on the Details tab of the article online
    • To access the appendix, click on the Details tab of the article online
  • 16
    • 85046806670 scopus 로고    scopus 로고
    • Washington (DC): EPA; 1992 Jun [cited 2018 Feb 26]
    • Environmental Protection Agency. R.E.D. facts: capsaicin [Internet]. Washington (DC): EPA; 1992 Jun [cited 2018 Feb 26]. Available from: https://archive.epa.gov/pesticides/ reregistration/web/pdf/4018fact .pdf
    • R.E.D. facts: capsaicin [Internet]
  • 19
    • 33846878293 scopus 로고    scopus 로고
    • Economic return of clinical trials performed under the pediatric exclusivity program
    • Li JS, Eisenstein EL, Grabowski HG, Reid ED, Mangum B, Schulman KA, et al. Economic return of clinical trials performed under the pediatric exclusivity program. JAMA. 2007; 297(5):480-8
    • (2007) JAMA , vol.297 , Issue.5 , pp. 480-488
    • Li, J.S.1    Eisenstein, E.L.2    Grabowski, H.G.3    Reid, E.D.4    Mangum, B.5    Schulman, K.A.6
  • 20
    • 85012920013 scopus 로고    scopus 로고
    • Six-month market exclusivity extensions to promote research offer substantial returns for many drug makers
    • Kesselheim AS, Rome BN, Sarpatwari A, Avorn J. Six-month market exclusivity extensions to promote research offer substantial returns for many drug makers. Health Aff (Millwood). 2017; 36(2):362-70
    • (2017) Health Aff (Millwood) , vol.36 , Issue.2 , pp. 362-370
    • Kesselheim, A.S.1    Rome, B.N.2    Sarpatwari, A.3    Avorn, J.4
  • 21
    • 85046747809 scopus 로고    scopus 로고
    • 141/2000 [Internet]. Brussels: European Commission [cited 2018 Feb 26]
    • European Parliament. Regulation (EC) No. 141/2000 [Internet]. Brussels: European Commission; 1999 [cited 2018 Feb 26]. Available from: https://ec.europa.eu/health/ sites/health/files/files/eudralex/ vol-1/reg_2000_141_cons-2009-07/ reg_2000_141_cons-2009-07_en .pdf
    • (1999) Regulation (EC) No
  • 22
    • 85046759218 scopus 로고    scopus 로고
    • Drugs for rare diseases have become uncommonly rich monopolies
    • [serial on the Internet]. 2017 Jan 17 [cited 2018 Feb 26]
    • Tribble SJ, Lupkin S. Drugs for rare diseases have become uncommonly rich monopolies. National Public Radio [serial on the Internet]. 2017 Jan 17 [cited 2018 Feb 26]. Available from: https://www.npr.org/ sections/health-shots/2017/01/17/ 509506836/drugs-for-rare-diseaseshave-become-uncommonly-richmonopolies
    • National Public Radio
    • Tribble, S.J.1    Lupkin, S.2
  • 23
    • 85046800413 scopus 로고    scopus 로고
    • [Internet]. London: EvaluatePharma; 2015 Oct [cited 2018 Feb 26]
    • EvaluatePharma. Orphan drug report 2015 [Internet]. London: EvaluatePharma; 2015 Oct [cited 2018 Feb 26]. Available from: http:// info.evaluategroup.com/rs/607-YGS-364/images/EPOD15.pdf
    • Orphan drug report 2015
  • 24
    • 85046802760 scopus 로고    scopus 로고
    • Sky-high prices for orphan drugs slam American families and insurers
    • [serial on the Internet]. 2017 Jan 17 [cited 2018 Feb 26]
    • Tribble SJ, Lupkin S. Sky-high prices for orphan drugs slam American families and insurers. Kaiser Health News [serial on the Internet]. 2017 Jan 17 [cited 2018 Feb 26]. Available from: http://khn.org/ news/sky-high-prices-for-orphandrugs-slam-american-families-andinsurers/
    • Kaiser Health News
    • Tribble, S.J.1    Lupkin, S.2
  • 25
    • 85046797760 scopus 로고    scopus 로고
    • [Internet]. London: Ernst and Young; 2015 Jun [cited 2018 Feb 26]
    • Ernst and Young. Impact of the orphan drug tax credit on treatments for rare disease [Internet]. London: Ernst and Young; 2015 Jun [cited 2018 Feb 26]. Available from: https://rarediseases.org/assets/ files/white-papers/2015-06-17.nordbio-ey-odtc.pdf
    • Impact of the orphan drug tax credit on treatments for rare disease
  • 26
    • 85046817798 scopus 로고    scopus 로고
    • Boston Herald [serial on the Internet]. 2013 Aug 11 [cited 2018 Feb 27]
    • Graham J. Biotechs push to save tax credit for rare-disease medicine makers. Boston Herald [serial on the Internet]. 2013 Aug 11 [cited 2018 Feb 27]. Available from: http:// www.bostonherald.com/business/ healthcare/2013/08/biotechs_ push_to_save_tax_credit_for_ rare_disease_medicine_makers# sthash.boVn5v9O.dpuf
    • Biotechs push to save tax credit for rare-disease medicine makers
    • Graham, J.1
  • 27
    • 85011008969 scopus 로고    scopus 로고
    • Biomarker-defined subsets of common diseases: policy and economic implications of Orphan Drug Act coverage
    • Kesselheim AS, Treasure CL, Joffe S. Biomarker-defined subsets of common diseases: policy and economic implications of Orphan Drug Act coverage. PLoS Med. 2017;14(1): e1002190
    • (2017) PLoS Med , vol.14 , Issue.1
    • Kesselheim, A.S.1    Treasure, C.L.2    Joffe, S.3
  • 28
    • 85046810854 scopus 로고    scopus 로고
    • [Internet]. Washington (DC): ASPE; 2016 Dec 7 [cited 2018 Feb 26]
    • Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation. Report to Congress: prescription drugs: innovation, spending, and patient access [Internet]. Washington (DC): ASPE; 2016 Dec 7 [cited 2018 Feb 26]. Available from: https://delauro.house.gov/ sites/delauro.house.gov/files/ Prescription-Drugs-Innovation-Spending-and-Patient-Access-12-07-16.pdf
    • Report to Congress: prescription drugs: innovation, spending, and patient access
  • 29
    • 85046762054 scopus 로고    scopus 로고
    • FDA's "safe and effective" drug approval based on widely varied data, study finds
    • Jan 21
    • Dennis B. FDA's "safe and effective" drug approval based on widely varied data, study finds. Washington Post. 2014 Jan 21
    • (2014) Washington Post
    • Dennis, B.1
  • 30
    • 79958036418 scopus 로고    scopus 로고
    • Characteristics of clinical trials to support approval of orphan vs nonorphan drugs for cancer
    • Kesselheim AS, Myers JA, Avorn J. Characteristics of clinical trials to support approval of orphan vs nonorphan drugs for cancer. JAMA. 2011;305(22):2320-6
    • (2011) JAMA , vol.305 , Issue.22 , pp. 2320-2326
    • Kesselheim, A.S.1    Myers, J.A.2    Avorn, J.3
  • 31
    • 85026659541 scopus 로고    scopus 로고
    • High generic drug prices and market competition: a retrospective cohort study
    • Dave CV, Kesselheim AS, Fox ER, Qiu P, Hartzema A. High generic drug prices and market competition: a retrospective cohort study. Ann Intern Med. 2017;167(3):145-51
    • (2017) Ann Intern Med , vol.167 , Issue.3 , pp. 145-151
    • Dave, C.V.1    Kesselheim, A.S.2    Fox, E.R.3    Qiu, P.4    Hartzema, A.5


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.