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Volumn 33, Issue 2, 2012, Pages 235-251

Time and money: An analysis of the legislative efforts to address the prescription drug shortage crisis in America

Author keywords

[No Author keywords available]

Indexed keywords

DRUG;

EID: 84862553920     PISSN: 01947648     EISSN: 1521057X     Source Type: Journal    
DOI: 10.1080/01947648.2012.686801     Document Type: Review
Times cited : (4)

References (57)
  • 1
    • 84862555045 scopus 로고    scopus 로고
    • Energy and Commerce, 112th Cong. 8 (2011) (testimony of Richard Paoletti, Vice President Lancaster General Health) (quoting Jacqueline Evans, Cancer Care for Women) [hereinafter Paoletti Testimony], available at
    • Energy and Commerce, 112th Cong. 8 (2011) (testimony of Richard Paoletti, Vice President Lancaster General Health) (quoting Jacqueline Evans, Cancer Care for Women) [hereinafter Paoletti Testimony], available at http://republicans. energycommerce. house.gov/Media/file/Hearings/Health/092311%20Drug%20Shortages/ Paoletti Testimony.pdf.
  • 2
    • 84862508947 scopus 로고    scopus 로고
    • USA TODAY, Sept. 13
    • Susan Kennedy, Op-Ed., Drug Shortage: What Can I Do?, USA TODAY, Sept. 13, 2011, http://www. usatoday.com/news/opinion/forum/story/2011-09-13/cancer- drug-shortage/50389896/1.
    • (2011) Op-Ed., Drug Shortage: What Can i Do?
    • Kennedy, S.1
  • 3
    • 84862555033 scopus 로고    scopus 로고
    • Drug shortages: National survey reveals high level of frus tration, low level of safety
    • Institute for Safe Medication Practices [hereinafter ISMP Report], available at
    • Institute for Safe Medication Practices, Drug Shortages: National Survey Reveals High Level of Frus tration, Low Level of Safety, 15 ISMP MEDICATION SAFETY ALERT! 1, 3 (2010) [hereinafter ISMP Report], available at http://www.ismp.org/newsletters/acutecare/articles/20100923.asp.
    • (2010) 15 Ismp Medication Safety Alert! , vol.1 , Issue.3
  • 4
    • 84862535923 scopus 로고    scopus 로고
    • Center for Drug Evaluation and Research Drug Shortage Workshop, available at
    • Center for Drug Evaluation and Research Drug Shortage Workshop, available at http://www.fda.gov/Drugs/NewsEvents/ucm265968.htm.
  • 5
    • 84862539989 scopus 로고    scopus 로고
    • Can the united states ensure an adequate supply of critical medications?
    • Joseph M. Hill & Cynthia Reilly, Can the United States Ensure an Adequate Supply of Critical Medications?, 1 FOOD & DRUG POL'Y FORUM. 1, 1 (2011).
    • (2011) 1 FOOD & DRUG POL'Y FORUM , vol.1 , pp. 1
    • Hill, J.M.1    Reilly, C.2
  • 6
    • 84862555034 scopus 로고    scopus 로고
    • Examining the Increase in Drug Shortages: Hearing on H.R. 2245 Before the Subcomm. on Health of the H. Comm. on Energy and Commerce, 112th Cong. 2-3 (2011) (statement of Howard Koh, Assistant Secretary for Health) [hereinafter Koh Testimony], available at
    • Examining the Increase in Drug Shortages: Hearing on H.R. 2245 Before the Subcomm. on Health of the H. Comm. on Energy and Commerce, 112th Cong. 2-3 (2011) (statement of Howard Koh, Assistant Secretary for Health) [hereinafter Koh Testimony], available at http://republicans.energycommerce. house.gov/Media/file/Hearings/Health/092311%20Drug%20Shortages/Kohtestimony.pdf.
  • 7
    • 84862537169 scopus 로고    scopus 로고
    • Drug Shortages Hit Record Levels in 2011, 2012 May Not Be Much Better, MODERN MED. (last visited Feb. 1, 2012)
    • Drug Shortages Hit Record Levels in 2011, 2012 May Not Be Much Better, MODERN MED., http://www.modernmedicine.com/modernmedicine/article/articleDetail. jsp?id=755523 (last visited Feb. 1, 2012).
  • 9
    • 84862555037 scopus 로고    scopus 로고
    • Koh Testimony, supra note 10, at 2.
    • Koh Testimony, supra note 10, at 2.
  • 10
    • 84862587991 scopus 로고    scopus 로고
    • Preserving Access to Life-Saving Medications Act, S. 296, 112th Cong. (2011);
    • Preserving Access to Life-Saving Medications Act, S. 296, 112th Cong. (2011);
  • 11
    • 84862555041 scopus 로고    scopus 로고
    • Preserving Access to Life-Saving Medications Act of 2011, H.R. 2245, 112th Cong. (2011).
    • Preserving Access to Life-Saving Medications Act of 2011, H.R. 2245, 112th Cong. (2011).
  • 12
    • 84862537172 scopus 로고    scopus 로고
    • Koh Testimony, supra note 10, at 2.
    • Koh Testimony, supra note 10, at 2.
  • 13
    • 80053509025 scopus 로고    scopus 로고
    • Impact of drug shortages on U.S. Health systems
    • Rola Kaakeh et al., Impact of Drug Shortages on U.S. Health Systems, 68 AM. J. HEALTH SYST. PHARM. 1811, 1811 (2011).
    • (2011) 68 AM. J. HEALTH SYST. PHARM. , vol.1811 , pp. 1811
    • Kaakeh, R.1
  • 14
    • 84862587990 scopus 로고    scopus 로고
    • Koh Testimony, supra note 10, at 2, 6, 7.
    • Koh Testimony, supra note 10, at 2, 6, 7.
  • 15
    • 84862535932 scopus 로고    scopus 로고
    • Kaakeh et al., supra note 19, at 1811.
    • Kaakeh et al., supra note 19, at 1811.
  • 16
    • 84862535931 scopus 로고    scopus 로고
    • Paoletti Testimony, supra note 1, at 7.
    • Paoletti Testimony, supra note 1, at 7.
  • 17
    • 84862554882 scopus 로고    scopus 로고
    • U.S. FOOD AND DRUG ADMIN
    • U.S. FOOD AND DRUG ADMIN., A REVIEW OF FDA'S APPROACH TO MEDICAL PRODUCT SHORTAGES 10, 13 (2011), available at http://www.fda.gov/downloads/AboutFDA/ ReportsManualsForms/Reports/UCM277755.pdf
    • (2011) A REVIEW of FDA'S APPROACH to MEDICAL PRODUCT SHORTAGES , vol.10 , pp. 13
  • 18
    • 84862535934 scopus 로고    scopus 로고
    • Koh Testimony, supra note 10, at 2, 6, 7
    • Koh Testimony, supra note 10, at 2, 6, 7;
  • 19
    • 84862555046 scopus 로고    scopus 로고
    • Paoletti Testimony, supra note 1, at 6.
    • Paoletti Testimony, supra note 1, at 6.
  • 20
    • 80052745187 scopus 로고    scopus 로고
    • FDA, US hospital and pharmacy groups report drug shortages a growing problem
    • Mike Mitka, FDA, US Hospital and Pharmacy Groups Report Drug Shortages a Growing Problem, 306 J.A.M.A. 1069, 1069 (2011).
    • (2011) 306 J.A.M.A. , vol.1069 , pp. 1069
    • Mitka, M.1
  • 21
    • 84862535933 scopus 로고    scopus 로고
    • Paoletti Testimony, supra note 1, at 2.
    • Paoletti Testimony, supra note 1, at 2.
  • 22
    • 84862537171 scopus 로고    scopus 로고
    • H. Comm. on Energy and Commerce, 112th Cong. 2 (2011) (statement of Charles Penley of the American Society of Oncology) [hereinafter Penley Testimony], available at
    • H. Comm. on Energy and Commerce, 112th Cong. 2 (2011) (statement of Charles Penley of the American Society of Oncology) [hereinafter Penley Testimony], available at http://republicans.energy commerce.house.gov/Media/ file/Hearings/Health/092311%20Drug%20Shortages/Penley Testimony. pdf.
  • 23
    • 68349108143 scopus 로고    scopus 로고
    • ASHP Guidelines on managing drug product shortages in hospitals and health systems
    • Erin R. Fox et al., ASHP Guidelines on Managing Drug Product Shortages in Hospitals and Health Systems, 66 AM. J. HEALTH-SYST. PHARM. 1399, 1401 (2009).
    • (2009) 66 AM. J. HEALTH-SYST. PHARM. , vol.1399 , pp. 1401
    • Erin, R.F.1
  • 24
    • 84862555042 scopus 로고    scopus 로고
    • Hearing Before the S. Comm. on Health Educ. Labor and Pensions, 112th Cong. 2 (2011) (statement of Deborah Autor, Commissioner for Global Regulatory Operations and Policy, FDA) [hereinafter Autor Testimony], available at
    • Hearing Before the S. Comm. on Health Educ. Labor and Pensions, 112th Cong. 2 (2011) (statement of Deborah Autor, Commissioner for Global Regulatory Operations and Policy, FDA) [hereinafter Autor Testimony], available at http://help.senate.gov/imo/media/doc/Autor.pdf.
  • 26
    • 84862535930 scopus 로고    scopus 로고
    • Examining the Increase in Drug Shortages: Hearing on H.R. 2245 Before the Subcomm. on Health of the H. Comm. on Energy and Commerce, 112th Cong. 7 (2011) (statement of Michael Alkire, Chief Operating Officer Premier Healthcare Alliance) [hereinafter Alkire Testimony], available at
    • Examining the Increase in Drug Shortages: Hearing on H.R. 2245 Before the Subcomm. on Health of the H. Comm. on Energy and Commerce, 112th Cong. 7 (2011) (statement of Michael Alkire, Chief Operating Officer Premier Healthcare Alliance) [hereinafter Alkire Testimony], available at http://republicans. energycommerce.house.gov/Media/file/Hearings/Health/092311%20Drug%20Shortages/ Alkire Testimony.pdf.
  • 27
    • 0036685394 scopus 로고    scopus 로고
    • FDA's role in responding to drug shortages
    • Valerie Jensen et al., FDA's Role in Responding to Drug Shortages, 59 AM. J. HEALTH SYS. PHARM. 1423, 1424 (2002);
    • (2002) 59 AM. J. HEALTH SYS. PHARM. , vol.1423 , pp. 1424
    • Jensen, V.1
  • 28
    • 80052790049 scopus 로고    scopus 로고
    • Drug shortages: Causes and cautions
    • Tara D. Mullins & Aaron M. Cook, Drug Shortages: Causes and Cautions, 34 ORTHOPEDICS 712, 713 (2011).
    • (2011) 34 ORTHOPEDICS , vol.712 , pp. 713
    • Mullins, T.D.1    Cook, A.M.2
  • 30
    • 84862587995 scopus 로고    scopus 로고
    • Hurricane georges leaves shortage of heart medicine
    • Oct. 29
    • Glenn Singer & Nancy McVicar, Hurricane Georges Leaves Shortage of Heart Medicine, SUN SENTI-NAL, Oct. 29, 1998, http://articles.sun-sentinel.com/ 1998-10-29/news/9810290017 1 heart-patients-chest-pain-nitroglycerin.
    • (1998) SUN SENTI-NAL
    • Singer, G.1    McVicar, N.2
  • 31
    • 84855181570 scopus 로고    scopus 로고
    • Mitigating the impact of medication shortage on public health
    • Walter Chambliss et al., Mitigating the Impact of Medication Shortage on Public Health, 51 J. AM. PHARMACISTS ASS'N 574, 575 (2011).
    • (2011) 51 J. AM. PHARMACISTS ASS'N , vol.574 , pp. 575
    • Chambliss, W.1
  • 32
    • 84862537175 scopus 로고    scopus 로고
    • Jensen et al., supra note 51, at 1423.
    • Jensen et al., supra note 51, at 1423.
  • 33
    • 84862587992 scopus 로고    scopus 로고
    • Examining the Increase in Drug Shortages: Hearing on H.R. 2245 Before the Subcomm. on Health of the H. Comm. on Energy and Commerce, 112th Cong. 2 (2011) (testimony of Sandy Kweder, Deputy Director of the FDA office of New Drugs) [hereinafter Kweder Testimony], available at
    • Examining the Increase in Drug Shortages: Hearing on H.R. 2245 Before the Subcomm. on Health of the H. Comm. on Energy and Commerce, 112th Cong. 2 (2011) (testimony of Sandy Kweder, Deputy Director of the FDA office of New Drugs) [hereinafter Kweder Testimony], available at http://republicans.energycommerce. house.gov/hearings/hearingdetail.aspx?NewsID=8926.
  • 34
    • 84862555044 scopus 로고    scopus 로고
    • Hearing on H.R. 2245 Before the Subcomm. on Health of the H. Comm. on Energy and Commerce, 112th Cong. 2, 9 (2011) (statement of Kevin Colgan on behalf of the American Society of Health System Pharmacists) [hereinafter Colgan Testimony], available at Paoletti Testimony, supra note 1, at 2, 6.
    • Hearing on H.R. 2245 Before the Subcomm. on Health of the H. Comm. on Energy and Commerce, 112th Cong. 2, 9 (2011) (statement of Kevin Colgan on behalf of the American Society of Health System Pharmacists) [hereinafter Colgan Testimony], available at http://republicans.energy commerce.house.gov/Media/ file/Hearings/Health/092311%20Drug%20Shortages/Colgan Testimony. pdf; Paoletti Testimony, supra note 1, at 2, 6.
  • 35
    • 84862537173 scopus 로고    scopus 로고
    • Koh Testimony, supra note 10, at 2, 10 (99 shortages prevented from Jan. 1, 2010 through Sept. 2011); Health and Human Services, Fact Sheet: Continued Progress on Reducing Drug Shortages (last visited Feb. 1, 2012) (96 prevented since Oct. 31, 2011, 233 total since Jan. 1, 2010)
    • Koh Testimony, supra note 10, at 2, 10 (99 shortages prevented from Jan. 1, 2010 through Sept. 2011); Health and Human Services, Fact Sheet: Continued Progress on Reducing Drug Shortages, http://www.hhs.gov/news/press/2011pres/12/ 20111215a fda.html (last visited Feb. 1, 2012) (96 prevented since Oct. 31, 2011, 233 total since Jan. 1, 2010).
  • 38
    • 84862555043 scopus 로고    scopus 로고
    • Reducing Prescription Drug Shortages, Exec. Order No. 13588, 76 Fed. Reg. 68, 295 (Nov. 3, 2011)
    • Reducing Prescription Drug Shortages, Exec. Order No. 13588, 76 Fed. Reg. 68, 295 (Nov. 3, 2011), available at http://www.whitehouse.gov/the-press- office/2011/10/31/executive-order-reducing-prescription-drug-shortages.
  • 40
    • 84862537166 scopus 로고    scopus 로고
    • Examining the Increase in Drug Shortages: Hearing on H.R. 2245 Before the Subcomm. on Health of the H. Comm. on Energy and Commerce, 112th Cong. 3 (2011) (statement of Jonathan M. Kafer, Vice President Sales and Marketing, Teva Health Systems) [hereinafter Kafer Testimony], avail able at
    • Examining the Increase in Drug Shortages: Hearing on H.R. 2245 Before the Subcomm. on Health of the H. Comm. on Energy and Commerce, 112th Cong. 3 (2011) (statement of Jonathan M. Kafer, Vice President Sales and Marketing, Teva Health Systems) [hereinafter Kafer Testimony], avail able at http://republicans.energycommerce.house.gov/Media/file/Hearings/Health/ 092311%20Drug% 20Shortages/Kafer Testimony. pdf.
  • 41
    • 84862514273 scopus 로고    scopus 로고
    • AM. SOC'Y HEALTH-SYS. PHARM. [hereinafter SUMMIT SUMMARY REPORT], available at
    • AM. SOC'Y HEALTH-SYS. PHARM., DRUG SHORTAGES SUMMIT SUMMARY REPORT 3 (2010) [hereinafter SUMMIT SUMMARY REPORT], available at http://www.ashp.org/ drugshortages/summitreport.
    • (2010) Drug Shortages Summit Summary Report , vol.3
  • 42
    • 84862535925 scopus 로고    scopus 로고
    • Frequently Asked Questions on Prescription Drug User Fees, FDA (last visited Feb. 1, 2012)
    • Frequently Asked Questions on Prescription Drug User Fees, FDA, http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ ucm069943.htm (last visited Feb. 1, 2012).
  • 43
    • 84862570003 scopus 로고    scopus 로고
    • 72 Fed. Reg. Oct. 12
    • Prescription Drug User Fee Rates Notice, 72 Fed. Reg. 58, 103 (Oct. 12, 2007), available at http://edocket.access.gpo.gov/2007/pdf/07-5052.pdf.
    • (2007) Prescription Drug User Fee Rates Notice , vol.58 , pp. 103
  • 44
    • 84862535927 scopus 로고    scopus 로고
    • Colgan Testimony, supra note 78, at 10.
    • Colgan Testimony, supra note 78, at 10.
  • 45
    • 84862535928 scopus 로고    scopus 로고
    • HANINGER ET AL., supra note 53, at 14.
    • HANINGER ET AL., supra note 53, at 14.
  • 46
    • 84862587987 scopus 로고    scopus 로고
    • Penley Testimony, supra note 32, at 9;
    • Penley Testimony, supra note 32, at 9;
  • 47
    • 84862587986 scopus 로고    scopus 로고
    • Colgan Testimony, supra note 78, at 10;
    • Colgan Testimony, supra note 78, at 10;
  • 48
    • 84862537170 scopus 로고    scopus 로고
    • Paoletti Testimony, supra note 1, at 8.
    • Paoletti Testimony, supra note 1, at 8.
  • 49
    • 84862587985 scopus 로고    scopus 로고
    • Penley Testimony, supra note 32, at 9.
    • Penley Testimony, supra note 32, at 9.
  • 50
    • 84862555039 scopus 로고    scopus 로고
    • HANINGER ET AL., supra note 53, at 8-9, 13.
    • HANINGER ET AL., supra note 53, at 8-9, 13.
  • 51
    • 84862555038 scopus 로고    scopus 로고
    • HANINGER ET AL., supra note 53, at 8-9, 13;
    • HANINGER ET AL., supra note 53, at 8-9, 13;
  • 52
    • 84862535929 scopus 로고    scopus 로고
    • A REVIEW OF FDA'S APPROACH, supra note 24, at 13-16.
    • A REVIEW OF FDA'S APPROACH, supra note 24, at 13-16.
  • 53
    • 84862555036 scopus 로고    scopus 로고
    • Kafer Testimony, supra note 104;
    • Kafer Testimony, supra note 104;
  • 54
    • 84862587989 scopus 로고    scopus 로고
    • SUMMIT SUMMARY REPORT, supra note 105.
    • SUMMIT SUMMARY REPORT, supra note 105.
  • 57
    • 84862537168 scopus 로고    scopus 로고
    • Securing the Pharmaceutical Supply Chain: Hearing Before the S. Comm. on Health Educ. Labor and Pensions, 112th Cong. (2011) (testimony of Deborah Autor, Commissioner for Global Regulatory Operations and Policy, FDA) available at
    • Securing the Pharmaceutical Supply Chain: Hearing Before the S. Comm. on Health Educ. Labor and Pensions, 112th Cong. (2011) (testimony of Deborah Autor, Commissioner for Global Regulatory Operations and Policy, FDA) available at http://www.help.senate.gov/hearings/hearing/?id=3fe78bef-5056-9502-5da8- cf290af9c334


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