Manufacturing and Regulatory Barriers to Generic Drug Competition: A Structural Model Approach

References

• Aguirregabiria V, Ho CY (2012) A dynamic oligopoly game of the US airline industry: Estimation and policy experiments. J. Econometrics 168(1):156–173.Crossref, Google Scholar
• Akşin Z, Ata B, Emadi SM, Su CL (2013) Structural estimation of callers’ delay sensitivity in call centers. Management Sci. 59(12):2727–2746.Link, Google Scholar
• Allon G, Federgruen A, Pierson M (2011) How much is a reduction of your customers’ wait worth? an empirical study of the fast-food drive-thru industry based on structural estimation methods. Manufacturing Service Oper. Management 13(4):489–507.Link, Google Scholar
• Association for Accessible Medicines (2017) Generic Drug Access and Savings in the U.S. Accessed July 17, 2017, https://accessiblemeds.org/resources/blog/2017-generic-drug-access-and-savings-us-report.Google Scholar
• Ayvaz S, Horn J, Hassanzadeh O, Zhu Q, Stan J, Tatonetti NP, Vilar S, et al. (2015) Toward a complete data set of drug–drug interaction information from publicly available sources. J. Biomedicine Inform. 55:206–217.Crossref, Google Scholar
• Bajari P, Hong H, Ryan SP (2010) Identification and estimation of a discrete game of complete information. Econometrica 78(5):1529–1568.Crossref, Google Scholar
• Ball G, Siemsen E, Shah R (2017) Do plant inspections predict future quality? The role of investigator experience. Manufacturing Service Oper. Management 19(4):534–550.Link, Google Scholar
• Berndt ER, Newhouse JP (2012) Pricing and reimbursement in U.S. pharmaceutical markets. NBER Working Paper 16297, National Bureau of Economic Research, Cambridge, MA.Google Scholar
• Berry ST (1992) Estimation of a model of entry in the airline industry. Econometrica 60(4):889–917.Crossref, Google Scholar
• Bray RL, Mendelson H (2012) Information transmission and the bullwhip effect: An empirical investigation. Management Sci. 58(5):860–875.Link, Google Scholar
• Bray RL, Mendelson H (2015) Production smoothing and the bullwhip effect. Manufacturing Service Oper. Management 17(2):208–220.Link, Google Scholar
• Brennan Z (2016) GDUFA II: FDA looks to speed up generic drug approval process. Accessed November 22, 2017, https://www.raps.org/regulatory-focus%E2%84%A2/news-articles/2016/9/gdufa-ii-fda-looks-to-speed-up-generic-drug-approval-process.Google Scholar
• Brennan Z (2017) FDA to speed reviews of more generic drugs, offers lists of those with no competition. Accessed November 5, 2017, https://www.raps.org/regulatory-focus%E2%84%A2/news-articles/2017/6/fda-to-speed-reviews-of-more-generic-drugs,-offers-lists-of-those-with-no-competition#:~:text=The%20US%20Food%20and%20Drug,are%20fewer%20than%20three%20ANDAs.Google Scholar
• Bresnahan TF, Reiss PC (1991) Empirical models of discrete games. J. Econometrics 48(1-2):57–81.Crossref, Google Scholar
• Bureau of Economic Analysis (2019) Gross domestic product: Implicit price deflator [gdpdef]. Retrieved from FRED, Federal Reserve Bank of St. Louis. Accessed March 16, 2020, https://fred.stlouisfed.org/series/GDPDEF.Google Scholar
• Ching AT (2010) A dynamic oligopoly structural model for the prescription drug market after patent expiration. Internat. Econom. Rev. 51(4):1175–1207.Crossref, Google Scholar
• Ciliberto F, Tamer E (2009) Market structure and multiple equilibria in airline markets. Econometrica 77(6):1791–1828.Crossref, Google Scholar
• CMS (2015) National health expenditures 2015 highlights. Retrieved from CMS, Centers for Medicare & Medicaid Services. Accessed November 18, 2017, http://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/downloads/highlights.pdf.Google Scholar
• Colak A, Bray RL (2016) Why do automakers initiate recalls? A structural econometric game. Working paper, Northwestern University, Evanston, IL.Google Scholar
• Conti RM, Berndt ER (2020) Four facts concerning competition in us generic prescription drug markets. Internat. J. Econom. Bus. 27(1):27–48.Crossref, Google Scholar
• Dave CV, Kesselheim AS, Fox ER, Qiu P, Hartzema A (2017) High generic drug prices and market competition: A retrospective cohort study. Ann. Internal Medicine. 167(3):145–151.Crossref, Google Scholar
• Deacon RT, Sonstelie J (1985) Rationing by waiting and the value of time: Results from a natural experiment. J. Political Econom. 93(4):627–647.Crossref, Google Scholar
• Declerck P (2012) Biologicals and biosimilars: A review of the science and its implications. Generics Biosimilars Initiative J. 1(1):13–16.Crossref, Google Scholar
• Department of Health and Human Services (2017) Understanding recent trends in generic drug prices. Accessed July 17, 2017, https://aspe.hhs.gov/system/files/pdf/175071/GenericsDrugpaperr.pdf.Google Scholar
• DrugBank (2017) The DrugBank database (Version 5.0). Accessed July 5, 2017, https://www.drugbank.ca/about.Google Scholar
• Ebert T (2016) The generic drug market. The New York Times. Accessed July 5, 2017, https://www.nytimes.com/2016/05/19/opinion/the-generic-drug-market.html.Google Scholar
• Ellison G, Ellison SF (2011) Strategic entry deterrence and the behavior of pharmaceutical incumbents prior to patent expiration. Amer. Econom. J. Microeconom. 3(1):1–36.Crossref, Google Scholar
• Emanuel EJ (2011) Shortchanging cancer patients. The New York Times. Accessed July 10, 2017, https://www.nytimes.com/2011/08/07/opinion/sunday/ezekiel-emanuel-cancer-patients.html.Google Scholar
• FDA (2017) Abbreviated new drug application: Generics. Retrieved from the FDA website. Accessed September 19, 2017, https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/abbreviatednewdrugapplicationandagenerics.Google Scholar
• FDA (2019) Generic competition and drug prices: New evidence linking greater generic competition and lower generic drug prices. Retrieved from the FDA website. Accessed March 25, 2020, https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/generic-competition-and-drug-pricesGoogle Scholar
• FDA (2020) Prioritization of the review of original ANDAs, amendments, and supplements. Retrieved from the FDA website. Accessed March 25, 2020, https://www.fda.gov/media/89061/download.Google Scholar
• Fein AJ (2012) Pharmacy profits over the generic life cycle: Explaining the NARP-NADAC data. Accessed November 25, 2017, https://www.drugchannels.net/2012/12/pharmacy-profits-over-generic-life.html.Google Scholar
• Frank RG, Salkever DS (1997) Generic entry and the pricing of pharmaceuticals. J. Econom. Management Strategy 6(1):75–90.Crossref, Google Scholar
• Gallant AR, Hong H, Khwaja A (2010) Dynamic entry with cross product spillovers: An application to the generic drug industry. Economic Research Initiatives at Duke (ERID) Working Paper Series No. 57, Duke University, Durham, NC.Google Scholar
• GAO (2016) Generic drugs under Medicare GAO-16-706. Accessed July 17, 2017, https://www.gao.gov/products/GAO-16-706.Google Scholar
• Gottlieb S (2017) FDA working to lift barriers to generic drug competition, https://www.fda.gov/news-events/fda-voices/fda-working-lift-barriers-generic-drug-competition.Google Scholar
• Grabowski HG, Vernon JM (1992) Brand loyalty, entry, and price competition in pharmaceuticals after the 1984 drug act. J. Law Econom. 35(2):331–350.Crossref, Google Scholar
• Gray JV, Siemsen E, Vasudeva G (2015) Colocation still matters: Conformance quality and the interdependence of R&D and manufacturing in the pharmaceutical industry. Management Sci. 61(11):2760–2781.Link, Google Scholar
• Guajardo JA, Cohen MA, Netessine S (2015) Service competition and product quality in the U.S. automobile industry. Management Sci. 62(7):1860–1877.Link, Google Scholar
• Hansen LP (1982) Large sample properties of generalized method of moments estimators. Econometrica 50(4):1029–1054.Crossref, Google Scholar
• Jiang ZZ, Huang Y, Beil DR (2022) The role of feedback in dynamic crowdsourcing contests: A structural empirical analysis. Management Sci. Forthcoming.Google Scholar
• Kaplan S (2015) One reason for high drug prices: A huge backlog of unapproved generic drugs. Accessed November 11, 2017.Google Scholar
• Karimi A, Mishra A, Natarajan K, Sinha K (2021) Managing commodity stock-outs in public health supply chains in developing countries: An empirical analysis. Production Oper. Management 30(9):3116–3142.Google Scholar
• Kim SW, Olivares M, Weintraub GY (2014) Measuring the performance of large-scale combinatorial auctions: A structural estimation approach. Management Sci. 60(5):1180–1201.Link, Google Scholar
• Kong E (2016) Estimating competitive effects in firm entry with applications in the generic pharmaceutical industry. Senior Essay, Yale University, New Haven, CT.Google Scholar
• Law V, Knox C, Djoumbou Y, Jewison T, Guo AC, Liu Y, Maciejewski A, et al. (2013) Drugbank 4.0: Shedding new light on drug metabolism. Nucleic Acids Res. 42(D1):D1091–D1097.Crossref, Google Scholar
• Lee CY, Chen X, Romanelli RJ, Segal JB (2016) Forces influencing generic drug development in the United States: A narrative review. J. Pharmaceutical Policy Practice 9(1):26.Crossref, Google Scholar
• Li J, Granados N, Netessine S (2014) Are consumers strategic? Structural estimation from the air-travel industry. Management Sci. 60(9):2114–2137.Link, Google Scholar
• Liberman JN, Roebuck MC (2010) Prescription drug costs and the generic dispensing ratio. J. Managment Care Pharmaceuticals 16(7):502–506.Crossref, Google Scholar
• Lu Y, Musalem A, Olivares M, Schilkrut A (2013) Measuring the effect of queues on customer purchases. Management Sci. 59(8):1743–1763.Link, Google Scholar
• Mani V, Kesavan S, Swaminathan JM (2015) Estimating the impact of understaffing on sales and profitability in retail stores. Production Oper. Management 24(2):201–218.Crossref, Google Scholar
• McFadden D (1989) A method of simulated moments for estimation of discrete response models without numerical integration. Econometrica 57(5):995–1026.Crossref, Google Scholar
• Meadows M (2003) Greater access to generic drugs. New FDA initiatives to improve drug reviews and reduce legal loopholes. FDA Consumer 37(5):12–17.Google Scholar
• Moon K, Bimpikis K, Mendelson H (2018) Randomized markdowns and online monitoring. Management Sci. 64(3):1271–1290.Link, Google Scholar
• Morton FMS (1999) Entry decisions in the generic pharmaceutical industry. RAND J. Econom. 30(3):421–440.Crossref, Google Scholar
• Olivares M, Terwiesch C, Cassorla L (2008) Structural estimation of the newsvendor model: An application to reserving operating room time. Management Sci. 54(1):41–55.Link, Google Scholar
• Olivares M, Weintraub GY, Epstein R, Yung D (2012) Combinatorial auctions for procurement: An empirical study of the chilean school meals auction. Management Sci. 58(8):1458–1481.Link, Google Scholar
• Olson L, Wendling BW (2013) Estimating the effect of entry on generic drug prices using Hatch-Waxman exclusivity. Working paper, Federal Trade Commission, Bureau of Economics, Washington, DC.Google Scholar
• Png IP, Reitman D (1994) Service time competition. RAND J. Econom. 25(4):619–634.Crossref, Google Scholar
• Rao A (2019) Strategic R&D investment decisions in the pharmaceutical industry. Working paper, University of Chicago, Chicago.Google Scholar
• Sagonowsky E (2017) The top 15 generic drugmakers by 2016 revenue. Accessed April 15, 2020, https://www.fiercepharma.com/special-report/top-15-generic-drugmakers-2016.Google Scholar
• Statista (2015) Top 20 companies based on unbranded generics U.S. market share during 2014-2015. Accessed July 5, 2017, https://www.statista.com/statistics/522095.Google Scholar
• Thomas K (2016) 20 states accuse generic drug companies of price fixing. Accessed June 5, 2021.Google Scholar
• Veeraraghavan S, Debo L (2009) Joining longer queues: Information externalities in queue choice. Manufacturing Service Oper. Management 11(4):543–562.Link, Google Scholar
• Woodcock J (2016) Implementation of the generic drug user fee amendments of 2012. Accessed July 5, 2017, https://www.fda.gov/newsevents/testimony/ucm484304.htm.Google Scholar
• Xu L, Mani V, Zhao H (2021) Not a box of nuts and bolts: Distribution channels for specialty drugs? Working Paper, Pennsylvania State University, University Park, PA.Google Scholar
• Yang L, Debo L, Gupta V (2016) Trading time in a congested environment. Management Sci. 63(7):2377–2395.Link, Google Scholar
• Yu Q, Allon G, Bassamboo A (2016) How do delay announcements shape customer behavior? An empirical study. Management Sci. 63(1):1–20.Link, Google Scholar
• Zheng F (2016) Spatial competition and preemptive entry in the discount retail industry. Columbia Business School Research Paper No. 16-37, Columbia University, New York.Google Scholar