1. IQVIA Institute for Healthcare Informatics Medicine use and spending in the US: a review of 2017 and outlook to 2022.; April 2018. Available at https://www.iqvia.com/institute/reports/medicine-use-and-spending-in-the-us-review-of-2017-outlook-to-2022, Accessed on 9.19.2018
2. DiJulio B, Firth J, Brodie M. Kaiser health tracking poll: August 2015. Menlo Park, CA: The Henry J. Kaiser Family Foundation. 2015 Sep.
3. Association for Accessible Medicines. The Case for Competition: 2019 Generic Drug and Biosimilars Access and Savings in the U.S Report. Available at https://accessiblemeds.org/sites/default/files/2019-09/AAM-2019-Generic-Biosimilars-Access-and-Savings-US-Report-WEB.pdf. Accessed on 10.25.2019
4. Association of Accessible Medicines. Generic Drug Access and Savings in the U.S. (2017) Available at: https://accessiblemeds.org/sites/default/files/2017-07/2017-AAM-Access-Savings-Report-2017-web2.pdf. Accessed on 9.19.2018
5. Food US. Drug Administration Safety and Innovation Act. Public law. 2012 Jul:112–44.
6. Center for Drug Evaluation and Research, US Food and Drug Administration. Good ANDA Submission Practices: Guidance for Industry (2018) Available at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM591134.pdf Accessed on 9.27.2019
7. Anderson L, Higby G. The spirit of voluntarism: a legacy of commitment and contribution: the United States pharmacopeia 1820–1995. United States Pharmacopeial; 1995 Sep 1.
8. Heller WM. The United States Pharmacopeia Its Value to the Professions. JAMA. 1970 Jul 27;213(4):576–9. 4914287
9. USP-NF, General Notices: 4. Monographs and General Chapters. Available at: https://online.uspnf.com/uspnf Accessed on 10.15.2018
10. Bhattacharyya L, Cecil T, Dabbah R, Roll D, Schuber S, Sheinin EB, et al. The value of USP public standards for therapeutic products. Pharmaceutical research. 2004 Oct 1;21(10):1725–31. doi: 10.1023/b:pham.0000045222.01170.4c 15553215
11. Heller WM. Rethinking some USP-FDA relationships. Journal of parenteral science and technology: a publication of the Parenteral Drug Association. 1986;40(3):80–1.
12. U.S. Pharmacopeial Convention. USP and FDA–Working Together to Protect Public Health. USP website. Available at: http://www.usp.org/about/public-policy/usp-fda-roles Accessed 9.19.2018
13. Heyward J, Padula W, Tierce JC, Alexander GC. The Value of US Pharmacopeial Standards: A Review of the Literature. Journal of pharmaceutical sciences. 2018 Jun 13.
14. U.S Food and Drug Administration, Center for Drug Evaluation and Research (U.S.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. [Rockville, Md.]: 2018. https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm>. Accessed on April 3, 2018.
15. United States Pharmacopeia and National Formulary (USP 41-NF 36). Rockville, MD: United States Pharmacopeial Convention; 2018. https://www.uspnf.com/ Accessed April 3, 2018.
16. IQVIA, IQVIA World Review. Copyright 2018, reprinted with permission. All rights reserved https://www.iqvia.com/ Accessed April 3, 2018.
17. U.S Food and Drug Administration. National Drug Code Directory, 2018. https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory. Accessed on April 3, 2018.
18. Dave CV, Hartzema A, Kesselheim AS. Prices of generic drugs associated with numbers of manufacturers. New England Journal of Medicine. 2017 Dec 28;377(26):2597–8. doi: 10.1056/NEJMc1711899 29281576
19. Derbyshire M. Promoting a competitive generics market in the US. Generics and Biosimilars Initiative Journal. 2016 Mar 1;5(1):45–6.
20. Kesselheim AS, Avorn J, Sarpatwari A. The high cost of prescription drugs in the United States: origins and prospects for reform. Jama. 2016 Aug 23;316(8):858–71. doi: 10.1001/jama.2016.11237 27552619
21. Jones GH, Carrier MA, Silver RT, Kantarjian H. Strategies that delay or prevent the timely availability of affordable generic drugs in the United States. Blood. 2016 Jan 1.
22. Federal Trade Commission. Pay-for-delay: how drug company pay-offs cost consumers billions. An FTC Staff Study. 2010 Jan. Available at https://www.ftc.gov/reports/pay-delay-how-drug-company-pay-offs-cost-consumers-billions-federal-trade-commission-staff Accessed on 9.19.2018
23. Sarpatwari A, Avorn J, Kesselheim AS. Using a drug-safety tool to prevent competition. New England Journal of Medicine. 2014 Apr 17;370(16):1476–8. doi: 10.1056/NEJMp1400488 24738666
24. Butler HN. REMS-Restricted Drug Distribution Programs and the Antitrust Economics of Refusals to Deal with Potential Generic Competitors. Fla. L. Rev. 2015;67:977.
25. Morton FS, Boller L. Enabling competition in pharmaceutical markets. Brookings, Brookings. 2017 May 1;2. Available at https://www.brookings.edu/wp-content/uploads/2017/05/wp30_scottmorton_competitioninpharma1.pdf Accessed on 9.19.2018
26. Lietzan Erika, A Second Look at the CREATES Act: What's Not Being Said (September 28, 2016). The Federalist Society Review, Volume 17, Issue 3, Forthcoming; University of Missouri School of Law Legal Studies Research Paper No. 2016–26. Available at SSRN: https://ssrn.com/abstract=2845041