1  “Guidance for Industry: Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product Shortage, draft,” (Food and Drug Administration, 2012), 2, http://goo.gl/db6De (accessed May 17, 2012). 

2  Kevin Haninger, “Economic Analysis of the Causes of Drug Shortages,” (Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, Office of Science and Data Policy, 2011), 3, http://goo.gl/YRhMm (accessed May 17, 2012).

3  Robert Lowes, “Sterile Injectables Account for Most of Drug Shortage,”(http://www.medscape.com, 2011), (accessed June 12, 2012). (Available with free registration.)

4  “Drug Shortages: FDA’s Ability to Respond Should Be Strengthened,” (Government Accountability Office, 2011), 18, http://goo.gl/I1QzO (accessed May 17, 2012).

5  Ibid., 6.

6  Ibid., 7.

7  Coleen Cherici et al., “Navigating Drug Shortages in American Healthcare,” (Premier Inc., 2011), 3, http://goo.gl/QtSO5 (accessed May 17, 2012).

8  “Drug Shortages: National Survey Reveals High Level of Frustration, Low Level of Safety,” (ISMP Medication Safety Alert, 2010), 1-6, http://goo.gl/U2bGA (accessed May 18, 2012).

9  “AHA Survey on Drug Shortages,” (American Hospital Association, 2011), http://goo.gl/YrLUx (accessed May 18, 2012). 

10  Ibid., 5.

11  Alice Goodman, “Drug Shortages Compromise Oncology Research,” 2012), http://goo.gl/0AmgV (accessed May 18, 2012). (Available with free registration.)

12  “A Review of FDA’s Approach to Medical Product Shortages,” (U.S. Food and Drug Administration, 2012), 31, http://goo.gl/5ARZs (accessed May 18, 2012).

13  Ibid., 32.

14  Haninger, “Economic Analysis of the Causes of Drug Shortages,” (Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, Office of Science and Data Policy, 2011), 6, http://goo.gl/YRhMm (accessed May 17, 2012).

15  “A Review of FDA’s Approach to Medical Product Shortages,” (U.S. Food and Drug Administration, 2012), 30, http://goo.gl/5ARZs (accessed May 18, 2012).

16  Haninger, “Economic Analysis of the Causes of Drug Shortages,” (Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, Office of Science and Data Policy, 2011), 11-12, http://goo.gl/YRhMm (accessed May 17, 2012).

17  “Drug Shortages: A closer look at products, suppliers and volume volatility,” (IMS Institute for Healthcare Informatics), 15, http://goo.gl/Rd3jx (accessed June 12, 2012). (Available with
free registration.)

18  Ibid., 16.

19  Haninger, “Economic Analysis of the Causes of Drug Shortages,” (Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, Office of Science and Data Policy, 2011), 7, http://goo.gl/YRhMm (accessed May 17, 2012).

20  Ibid., 6.

21  Cherici et al., “Navigating Drug Shortages in American Healthcare,” (Premier Inc., 2011), 1, http://goo.gl/QtSO5 (accessed May 17, 2012).

22  “Drug Shortages: A closer look at products, suppliers and volume volatility,” (IMS Institute for Healthcare Informatics), 3, http://goo.gl/Rd3jx (accessed June 12, 2012). (Available with free registration.)

23  Ibid., 8.

24  Erin R. Fox, “ASHP Guidelines on Managing Drug Product Shortages in Hospitals and Health Systems,” American Journal of Health-System Pharmacy 66, no. 15: 1401-02, http://goo.gl/u3DVl (accessed June 12, 2012). (Available with free registration.)

25  Coleen Cherici et al., “Buyer Beware: Drug Shortages and the Gray Market,” (Premier Inc., 2011), 2, http://goo.gl/2UgDN (accessed May 18, 2012).

26  Joseph M. Hill and Cynthia O’Reilly, “Can the United States Ensure an Adequate Supply of Critical Medications,” (FDLI’s Food and Drug Policy Forum, 2011), 5, http://goo.gl/rlCcG (accessed May 18, 2012).

27  Ali Yurokoglu, “Medicare Reimbursements and Shortages of Sterile Injectable Pharmaceuticals,” (Graduate School of Business, Stanford University and NBER, 2012), 2, http://goo.gl/fVkH2 (accessed June 12, 2012). Yurokoglu is affiliated with Stanford University’s Graduate School of Business and the National Bureau of Economic Research. U. Tirelli et al., “Oncologic drug shortages also in Italy,” European Review for Medical and Oncological Sciences, Volume 16, Number 1: 138-139, http://www.europeanreview.org/ article/1283. (accessed June 13, 2012). (Paid registration required.)

28  Mandy L. Gatesman and Thomas J. Smith, “The Shortage of Essential Chemotherapy Drugs in the United States,” (New England Journal of Medicine, 2011), 1654, http://goo.gl/y7Xzk (accessed June 12, 2012). (Available with free registration.)

29  Brett J. Skinner and Mark Rovere, “Canada’s Drug Price Paradox 2010,” (Fraser Institute, 2010), 2, http://goo.gl/6mdSi (accessed May 18, 2012).

30  Emily Jackson, “Drug Shortages: Single Supplier for Generic Injectables at Root of Crisis in Canada,” The Toronto Star, May 18, 2012, http://goo.gl/4fl1s (accessed June 11, 2012).

31  Ali Yurokoglu, “Medicare Reimbursements and Shortages of Sterile Injectable Pharmaceuticals,” (Graduate School of Business, Stanford University and NBER, 2012), 20, http://goo.gl/fVkH2 (accessed June 12, 2012).

32  “Drug Shortages: FDA’s Ability to Respond Should Be Strengthened,” (Government Accountability Office, 2011), 5-8, http://goo.gl/I1QzO (accessed May 17, 2012); Cherici et al., “Navigating Drug Shortages in American Healthcare,” (Premier Inc., 2011), 2, http://goo.gl/QtSO5 (accessed May 17, 2012).

33  “Drug Shortages: FDA’s Ability to Respond Should Be Strengthened,” (Government Accountability Office, 2011), 23, http://goo.gl/I1QzO (accessed May 17, 2012).

34  Edward Cox, “Introductory Comments and CDER Perspective on Drug Shortages transcript,” (The Food and Drug Administration, 2011), 34, http://goo.gl/Kj47X (accessed May 18, 2012).

35  Hill and O’Reilly, “Can the United States Ensure an Adequate Supply of Critical Medications,” (FDLI’s Food and Drug Policy Forum, 2011), 4, http://goo.gl/rlCcG (accessed May 18, 2012).

36  “Summary Report of the Drug Shortages Summit co-convened by the American Society of Health-System Pharmacists, the American Society of Anesthesiologists, the American Society of Clinical Oncology, and the Institute for Safe Medication Practices,” (American Society of Health-System Pharmacists, 2010), 3, http://goo.gl/WwKXv (accessed June 11, 2012).

37  “OGD Funding: GPhA Position,” (Generic Pharmaceutical Association, 2012), http://goo.gl/tUWwU (accessed May 18, 2012).

38  Kurt R. Karst, “OGD’s ANDA Backlog and Median ANDA Approval Times Are Up - WAY UP! ‘The Solution Lies in Resources,’ Says FDA Commissioner Hamburg,” (FDA Law Blog: Hyman, Phelps & McNamara, 2010), http://goo.gl/thhQ6 (accessed May 18, 2012).

39  Cherici et al., “Navigating Drug Shortages in American Healthcare,” (Premier Inc., 2011), 2, http://goo.gl/QtSO5 (accessed May 17, 2012). “Summary Report of the Drug Shortages Summit co-convened by the American Society of Health-System Pharmacists, the American Society of Anesthesiologists, the American Society of Clinical Oncology, and the Institute for Safe Medication Practices,” (American Society of Health-System Pharmacists, 2010), 3,
http://goo.gl/WwKXv (accessed June 11, 2012).

40  Erin R. Fox, “Drug Shortage Update: Current Status & Significant Trends,” (University of Utah Hospitals & Clinics, 2011), 10-11, http://goo.gl/dcdcZ (accessed May 18, 2012).

41  “Summary Report of the Drug Shortages Summit co-convened by the American Society of Health-System Pharmacists, the American Society of Anesthesiologists, the American Society of Clinical Oncology, and the Institute for Safe Medication Practices,” (American Society of Health-System Pharmacists, 2010), 5, http://goo.gl/WwKXv (accessed June 11, 2012).

42  For example, “Heparin Crisis 2008: A Tipping Point for Increased FDA Enforcement in the Pharma Sector” (Washington, DC: Food and Drug Law Institute, August 2010), http://goo.gl/8vVX4. (Paid registration required.)

43  Jane Akre, “More Deaths Reported As Baxter Expands Heparin Recall,” (Injury Board National Newsdesk, 2008), http://goo.gl/SZ6Rb (accessed May 18, 2012).

44  “Summary Report of the Drug Shortages Summit co-convened by the American Society of Health-System Pharmacists, the American Society of Anesthesiologists, the American Society of Clinical Oncology, and the Institute for Safe Medication Practices,” (American Society of Health-System Pharmacists, 2010), 3, http://goo.gl/WwKXv (accessed June 11, 2012).

45  Joseph Antos, “What Does Medicare Part D Say About the Ryan Plan?,” RealClearMarkets.com (June 15, 2011), http://goo.gl/Gm5A0, (accessed June 13, 2012).

46  Daniel Levinson, “Medicaid Drug Price Comparison: Average Sales Price to Average Wholesale Price,” (Department of Health and Human Services: Office of Inspector General, 2005), 8, http://goo.gl/kqUbv (accessed May 21, 2012).

47  Ali Yurokoglu, “Medicare Reimbursements and Shortages of Sterile Injectable Pharmaceuticals,” (Graduate School of Business, Stanford University and NBER, 2012), 16, http://goo.gl/fVkH2 (accessed June 12, 2012).

48  Haninger, “Economic Analysis of the Causes of Drug Shortages,” (Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, Office of Science and Data Policy, 2011), Summary, 7, http://goo.gl/YRhMm (accessed May 17, 2012).

49  Stephen Schimpff and Curt Civin, “What Really Needs to Be Done About the Critical Shortage of Cancer Drugs,” (The Health Care Blog, 2011), http://goo.gl/uzz6J (accessed June 11, 2012).

50  Drug Pricing: Manufacturer Discounts in the 340B Program Offer Benefits but Federal Oversight Needs Improvement, GAO-11-836 (Washington, DC: Government Accounting Office, September 2011), 2.

51  John Goodman, “Death by Regulation,” (John Goodman’s Health Policy Blog, 2011), http://goo.gl/jJwk4 (accessed May 21, 2012).

52  “Drug Pricing: Manufacturer Discounts in the 340B Program Offer Benefits but Federal Oversight Needs Improvement, GAO-11-836,” (Government Accountability Office, 2011), 2-3, http://goo.gl/tz5ij (accessed May 21, 2012).

53  Ibid., 18-19.

54  “Medicaid Drug Rebate Program” (Baltimore, MD: Centers for Medicare & Medicaid Services, 2012),http://goo.gl/KgWxE, (accessed June 13, 2012).

55  “Congress Changes Definition of Average Manufacturer Price ... Again,” (Arnold & Porter, LLP, 2010), http://goo.gl/PNGep (accessed May 21, 2012).

56  Siran K. Koroukian et al., “Survival Disparities by Medicaid Status: An Analysis of 8 Cancers,”(Cancer, 2011), http://goo.gl/rlqid (accessed June 12, 2012). (Available with free registration.)

57  Roy Avik, “The Medicaid Mess: How Obamacare Makes It Worse,” 2012), http://goo.gl/qQVb1 (accessed June 11, 2012).

58  Barack Obama, “Reducing Prescription Drug Shortages, Executive Order 13588,” (The White House, 2011), http://goo.gl/I9Ozz (accessed May 21, 2012).

59  Ibid.

60  “Guidance for Industry: Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product Shortage, draft,” (Food and Drug Administration, 2012), http://goo.gl/db6De (accessed May 17, 2012).

61  Section 506C of the federal Food, Drug and Cosmetic Act.

62  “Guidance for Industry: Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product Shortage, draft,” (Food and Drug Administration, 2012), 6, http://goo.gl/db6De (accessed May 17, 2012).

63  Ibid., 7.

64  Ibid., 9.

65  “Legislative Summary: Drug Shortages Provisions Within the Food and Drug Administration Safety and Innovation Act (S.3187),” (American Society of Health-System Pharmacists, 2012),
http://goo.gl/eFz9w (accessed June 11, 2012).

66  “Drug Shortages: FDA’s Ability to Respond Should Be Strengthened,” (Government Accountability Office, 2011), 38-42, http://goo.gl/I1QzO (accessed May 17, 2012).

67  “Guidance for Industry: Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product Shortage, draft,” (Food and Drug Administration, 2012), 4, http://goo.gl/db6De (accessed May 17, 2012).

68  “A Review of FDA’s Approach to Medical Product Shortages,” (U.S. Food and Drug Administration, 2012), 10, http://goo.gl/5ARZs (accessed May 18, 2012).

69  “FDA Acts to Bolster Supply of Critically Needed Cancer Drugs,” (U.S. Food and Drug Administration, 2012), http://goo.gl/N8jxJ (accessed May 21, 2012).

70  Margaret Hamburg, “Six Month Check Up: FDA’s Work on Drug Shortages,” (FDA Voice Blog, 2012), http://goo.gl/oRwcB (accessed June 11, 2012).

71  Hill and O’Reilly, “Can the United States Ensure an Adequate Supply of Critical Medications,” (FDLI’s Food and Drug Policy Forum, 2011), 1-3, http://goo.gl/rlCcG (accessed May 18, 2012).

72  “Drug Shortages: National Survey Reveals High Level of Frustration, Low Level of Safety,” (ISMP Medication Safety Alert, 2010), 1-6, http://goo.gl/U2bGA (accessed May 18, 2012).

73  “Summary Report of the Drug Shortages Summit co-convened by the American Society of Health-System Pharmacists, the American Society of Anesthesiologists, the American Society of Clinical Oncology, and the Institute for Safe Medication Practices,” (American Society of Health-System Pharmacists, 2010), 3, http://goo.gl/WwKXv (accessed June 11, 2012).

74  Hill and O’Reilly, “Can the United States Ensure an Adequate Supply of Critical Medications,” (FDLI’s Food and Drug Policy Forum, 2011), 6-7, http://goo.gl/rlCcG (accessed May 18, 2012).

75  “Drug Shortages: GPhA Position,” (Generic Pharmaceutical Association, 2012), http://goo.gl/rD3Qr (accessed May 21, 2012).

76  “GPhA Applauds Senate HELP Committee for Favorably Reporting Historic User Fee Proposals,” (Generic Pharmaceutical Association, 2012), http://goo.gl/qIlQQ (accessed May 21, 2012).

77  Graham, “Leviathan’s Drug Problem: Increasing Patients’ Choices Through International Competition in Pharmaceutical Regulation,” (Pacific Research Institute, 2010), 35-36, http://goo.gl/6yyMl (accessed May 21, 2012).

78  Ibid., 37.

79  “UnitedHealthcare Report Recommends Adopting New
Cancer Care Payment Model to Reward Physicians for Health Outcomes,” (UnitedHealthcare, 2012), http://goo.gl/Tdwpj (accessed June 12, 2012).