Drug Shortages, Today and Tomorrow—An Industry Perspective

References

1. 1.↵
   1. Weaver C.,
   2. Whalen J.

   How fake cancer drugs entered U.S. The Wall Street Journal 20 July 2012: http://www.wsj.com/articles/SB10001424052702303879604577410430607090226; Edelson, E. Report confirms source of contaminated heparin. The Washington Post 3 December 2008: http://www.washingtonpost.com/wp-dyn/content/article/2008/12/03/AR2008120302758.html.
2. 2.↵
   See Food and Drug Administration Safety and Innovation Act of 2012, Pub. L. 112-144 (Jul. 9, 2012).
3. 3.↵
   See Drug Quality and Security Act of 2013, Pub. L. 113-54 (Nov. 27, 2013).
4. 4.↵
   1. Bigood J.,
   2. Tavernise S.

   1. Hamburg M.

   “Protecting the Public from Unsafe Compounded Drug Products,” FDA, Web. http://blogs.fda.gov/fdavoice/index.php/2014/12/protecting-the-public-from-unsafe-compounded-drug-products/; Bigood J., Tavernise S. Pharmacy executives face murder charges in meningitis deaths. The New York Times 17 December 2014, A25.
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   Centers for Disease Control and Prevention (CDC). Multistate outbreak of fungal meningitis and other infections. CDC, Web. http://www.cdc.gov/hai/outbreaks/meningitis.html.
6. 6.↵
   See Drug Supply Chain Security Act of 2013, Pub. L. 113-54 (Nov. 27, 2013).
7. 7.↵
   See Falsified Medicines Directive 2011/62/EU.
8. 8.↵
   See Safe Doses Act of 2012, Pub. L. 112-186 (Oct. 5, 2012).
9. 9.↵
   See Food and Drug Administration Safety and Innovation Act of 2013, Title X, 21 U.S.C. §356c.
10. 10.↵
    21 U.S.C. §356c(c); Current and resolved drug shortages and discontinuances reported to FDA. FDA, Web: http://www.accessdata.fda.gov/scripts/drugshortages/default.cfm.
11. 11.↵
    See Food and Drug Administration Safety and Innovation Act of 2013, Title X, 21 U.S.C. §356c(e).
12. 12.↵
    See Food and Drug Administration Safety and Innovation Act of 2013, Title X, 21 U.S.C. §356c(g).
13. 13.↵
    Report to Congress, First Annual Report on Drug Shortages for Calendar Year 2013 Required by Section 1002 of the Food and Drug Administration Safety and Innovation Act. FDA, Web: http://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM384892.pdf.
14. 14.↵
    Strategic plan for preventing and mitigating drug shortages. FDA, Web: http://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM372566.pdf.
15. 15.↵
    See Food and Drug Administration Safety and Innovation Act of 2013, Title X, 21 U.S.C. §356c(f).
16. 16.↵
    Drug shortages: non-compliance with notification requirement. FDA, Web: http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm403902.htm.
17. 17.↵
    See Final Report by the Inter-Associations Team with Representatives from EFPIA/EGA/AESGP/PPTA, ISPE, and PDA on Prevention of Drug Shortages Based on Quality and Manufacturing Issues, 23 December 2014, http://www.pda.org/docs/default-source/website-document-library/scientific-and-regulatory-affairs/drug-shortage/interrupted-supply-inter-association-summary-final-report-2014.pdf?sfvrsn=4.
18. 18.↵
    Strategic plan for preventing and mitigating drug shortages. FDA, page 12, Web: http://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM372566.pdf.
19. 19.↵
    DSCSA implementation: product tracing requirements—compliance policy. FDA, Web: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM427867.pdf.