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The Effect of Unannounced Inspection on Prevention of Drug Fraud

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Abstract

Alarge number of incidents related to fake/inferior-quality drugs have occurred in China in recent years. In order to reduce drug crimes, the China Food and Drug Administration (CFDA) has exploited the new supervision approach, i.e., unannounced inspection (UI), since September 2014. However, the effectiveness of UI in driving drug producers to put more effort into meeting the requirements of Good Manufacturing Practice (GMP) is yet to be ascertained. In this paper we apply game theory to study the effects of UI on the prevention of drug fraud, drug producers’ profits, and social welfare under scenarios of complete and incomplete information. We show that UI is not always an effective way of supervision. Specifically, if the upper bound on the punishment is not very large, UI can drive the firmto make the largest self-supervision effort only when the firm’s technical level is high and the supervision cost is low. Otherwise, UI cannot drive the firm to make the largest self-supervision effort. Under incomplete information, firms with a high technical level would adopt more self-supervision and make more profit than those with a low technical level. Moreover, we design a new mechanism under incomplete information that can incentive drug producers to make greater self-supervision effort to meet the requirements of GMP under certain conditions.

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References

  • Anis AH, Wen Q (1998). Price regulation of pharmaceuticals in Canada. Journal of Health Economics 17(1): 21–38.

    Article  Google Scholar 

  • Avenhaus R, Canty MJ (2012). Inspection games. Springer, New York.

    Book  MATH  Google Scholar 

  • Babich V, Tang CS (2012). Managing opportunistic supplier product adulteration: Deferred payments, inspection, and combined mechanisms. Manufacturing and Service Operations Management 14(2): 301–314.

    Article  Google Scholar 

  • Badri MA, Davis D, Davis D (1995). A study of measuring the critical factors of quality management. International Journal of Quality and Reliability Management 12(2): 36–53.

    Article  Google Scholar 

  • Baiman S, Fischer PE, Rajan MV (2000). Information, contracting, and quality costs. Management Science 46(6): 776–789.

    Article  Google Scholar 

  • Baiman S, Fischer PE, Rajan MV (2001). Performance measurement and design in supply chains. Management Science 47(1): 173–188.

    Article  MATH  Google Scholar 

  • Balachandran KR, Radhakrishnan S (2005). Quality implications of warranties in a supply chain. Management Science 51(8): 1266–1277.

    Article  MATH  Google Scholar 

  • Becker GS (1968). Crime and punishment: an economic approach. Journal of Political Economy 76(2): 169–217.

    Article  Google Scholar 

  • Border KC, Sobel J (1987). Samurai accountant: A theory of auditing and plunder. The Review of Economic Studies 54(4): 525–540.

    Article  MathSciNet  MATH  Google Scholar 

  • Brocas I (2004). Optimal regulation of cooperative R&D under incomplete information. The Journal of Industrial Economics 52(1): 81–120.

    Article  MathSciNet  Google Scholar 

  • Carbonari L, Atella V, Bhattacharya J (2010). Pharmaceutical industry, drug quality and regulation–evidence from US and Italy. CEIS Working Paper No. 138. Available at SSRN: https://ssrn.com/abstract=1316805.

    Google Scholar 

  • Chander P, Wilde LL (1998). A general characterization of optimal income tax enforcement. The Review of Economic Studies 65(1): 165–183.

    Article  MathSciNet  MATH  Google Scholar 

  • Chao GH, Iravani SMR, Savaskan RC (2009). Quality improvement incentives and product recall cost sharing contracts. Management Science 55(7): 1122–1138.

    Article  MATH  Google Scholar 

  • Chater A (2006). FDA warns RFID needed now to protect drug safety. Drug Store News 28(17): 55.

    Google Scholar 

  • Chen J, Hu Q (2015). Optimal payment scheme when the supplier’s quality level and cost are unknown. European Journal of Operational Research 245(3): 731–742.

    Article  MathSciNet  MATH  Google Scholar 

  • Chen KH, Metcalf RW (1980). The relationship between pollution control record and financial indicators revisited. Accounting Review 55(1): 168–177.

    Google Scholar 

  • China Food and Drug Administration. The Food and Drug Regulatory Statistical Yearbook 2013. Retrieved December 23, 2014, http: //samr.cfda.gov.cn/WS01/CL0108/111300.html.

  • China Food and Drug Administration. The Food and Drug Regulatory Statistical Yearbook 2014. Retrieved July 24, 2015, http: //samr.cfda.gov.cn/WS01/CL0108/125301.html.

  • China Food and Drug Administration. The track inspection result ofNorth China Pharmaceutical Group Xiantai Pharmaceutical. Retrieved March 29, 2016, http: //samr.cfda.gov.cn/WS01/CL1760/148787.html.

  • China Food and Drug Administration. Unannounced inspection status of Xiuzheng pharmaceutical group co., LTD. (Liuhe factory). Retrieved November 15, 2014, http: //samr.cfda.gov.cn/WS01/CL1760/109230.html.

  • Cockburn R, Newton PN, Agyarko EK, Akunyili D, White NJ (2005). The global threat of counterfeit drugs: Why industry and governments must communicate the dangers. PLoS Medicine 2(4): 302.

    Article  Google Scholar 

  • Damania R (2002). Environmental controls with corrupt bureaucrats. Environment and Development Economics 7(3): 407–427.

    Article  Google Scholar 

  • Danzon PM, Chao LW (2000a). Cross–national price differences for pharmaceuticals: How large, and why? Journal of Health Economics 19(2): 159–195.

    Article  Google Scholar 

  • Danzon PM, Chao LW (2000b). Does regulation drive out competition in pharmaceutical markets? The Journal of Law and Economics 43(2): 311–358.

    Article  Google Scholar 

  • Dechenaux E, Samue A (2014). Announced vs. surprise inspections with tipping–off. European Journal of Political Economy 34: 167–183.

    Article  Google Scholar 

  • Dechenaux E, Samuel A (2016). Optimal fines under announced and surprise inspections. Journal of Public Economic Theory 18(5): 786–801.

    Article  Google Scholar 

  • Dechenaux E, Samuel A (2015). Regulatory inspection regimes and oligopoly competition. Available at SSRN: https: //ssrn.com/abstract=2739133 or http: //dx.doi.org/10.2139/ssrn.2739133.

    Book  Google Scholar 

  • Fisher FM, Temin P (1973). Returns to scale in research and development: What does the schumpeterian hypothesis imply? Journal of Political Economy 81(1): 56–70.

    Article  Google Scholar 

  • Goodman C, Kachur SP, Abdulla S, Bloland P, Mills A (2007). Drug shop regulation and malaria treatment in Tanzania–why do shops break the rules, and does it matter? Health Policy and Planning 22(6): 393–403.

    Article  Google Scholar 

  • Handley SM, Gray JV (2013). Inter–organizational quality management: The use of contractual incentives and monitoring mechanisms with outsourced manufacturing. Production and Operations Management 22(6): 1540–1556.

    Article  Google Scholar 

  • Harsanyi JC (1982). Games with incomplete information played by "Bayesian" players, I–III: Part I. The basic model. Management Science 14(3): 159–182.

    MATH  Google Scholar 

  • Hengster P, Hermann M, Pirkebner D, Draxl A, Margreiter R (2005). Islet isolation and GMP, ISO 9001: 2000: What do we need–a 3–year experience. Transplantation Proceedings 37(8): 3407–3408.

    Article  Google Scholar 

  • Henningfield JE, Schuster CR (2009). Risk management and post–marketing surveillance of CNS drugs. Drug and Alcohol Dependence 105(3): S56–S64.

    Book  Google Scholar 

  • Hsieh CC, Liu YT (2010). Quality investment and inspection policy in a supplier–manufacturer supply chain. European Journal of Operational Research 202(3): 717–729.

    Article  MATH  Google Scholar 

  • Hurwicz L, Reiter S (2006). Designing Economic Mechanisms. Cambridge University Press, Cambridge.

    Book  Google Scholar 

  • Innes R (2001). Violator avoidance activities and selfreporting in optimal law enforcement. Journal of Law, Economics, and Organization 17(1): 239–256.

    Article  Google Scholar 

  • Klimberg R, Revelle C, Cohon J (1992). Improving the effectiveness of FDA drug inspection. Operations Research 40(5): 845–855.

    Article  Google Scholar 

  • Koh R, Schuster EW, Chackrabarti I, Bellman A (2003). Securing the pharmaceutical supply chain. White Paper, Auto–ID Labs, Massachusetts Institute of Technology 1–19.

    Google Scholar 

  • Krysiak FC, Oberauner IM (2010). Environmental policy à la carte: Letting firms choose their regulation. Journal of Environmental Economics and Management 60(3): 221–232.

    Article  MATH  Google Scholar 

  • Laffont JJ, Tirole J (1993). A Theory of incentives in procurement and regulation. MIT press, Massachusetts.

    Google Scholar 

  • Lapré MA, Mukherjee AS, Wassenhove LNV (2000). Behind the learning curve: Linking learning activities to waste reduction. Management Science 46(5): 597–611.

    Article  Google Scholar 

  • Leiderman DB (2009). Risk management of drug products and the US Food and Drug Administration: Evolution and context. Drug and Alcohol Dependence 105(3): S9–S13.

    Google Scholar 

  • Lim WS (2001). Producer–supplier contracts with incomplete information. Management Science 47(5): 709–715.

    Article  MATH  Google Scholar 

  • Malik AS (1993). Self–reporting and the design of policies for regulating stochastic pollution. Journal of Environmental Economics and Management 24(3): 241–257.

    Article  Google Scholar 

  • McClellan M (2007). Fundamental improvements in drug safety for the 21st Century: Time for systematic, electronic infrastructure. AEI–Brookings Joint Center for Regulatory Studies.

    Google Scholar 

  • Miller FH (2007). Adverse drug reactions, medical accidents, and patient safety. Boston Univ. School of Law Working Paper No. 07–11. Available at SSRN: https: //ssrn.com/abstract=995503.

    Google Scholar 

  • Mookherjee D, Png I (1989). Optimal auditing, insurance, and redistribution. The Quarterly Journal of Economics 104(2): 399–415.

    Article  Google Scholar 

  • Myerson RB (1979). Incentive compatibility and the bargaining problem. Econometrica 47(1): 61–73.

    Article  MathSciNet  MATH  Google Scholar 

  • Plambeck EL, Taylor T (2016). Supplier evasion of a buyer’s audit: Implications for motivating supplier social and environmental responsibility. Manufacturing and Service Operations Management 18(2): 184–197.

    Article  Google Scholar 

  • Reyniers DJ, Tapiero CS (1995a). Contract design and the control of quality in a conflictual environment. European Journal of Operational Research 82(2): 373–382.

    Article  MATH  Google Scholar 

  • Reyniers DJ, Tapiero CS (1995b). The delivery and control of quality in supplier–producer contracts. Management Science 41(10): 1581–1589.

    Article  MATH  Google Scholar 

  • Rice JA (1995). Preparing for an unannounced inspection: What to do when an inspector shows up. Environmental Progress 14(3): 209–212.

    Article  Google Scholar 

  • Riley JG (2001). Silver signals: Twenty–five years of screening and signaling. Journal of Economic Literature 39(2): 432–478.

    Article  Google Scholar 

  • Rodriguez J (2005). How to prepare for a systems–based inspection–understanding FDA’s risk–based inspections approach. Journal of GXP Compliance 9(4): 14.

    Google Scholar 

  • Rosen S (1982). Authority, control, and the distribution of earnings. Bell Journal of Economics 13(2): 311–323.

    Article  Google Scholar 

  • Sina. Beilu Pharmaceutical, Hansen Pharmaceutical and other pharmaceutical companies involved in the "chromium exceeded" event. Retrieved Jannuary 5, 2016, http: //finance.sina.com.cn/stock/s/2016–01–05/doc–ifxneept3710146.shtml.

  • Skreta V (2006). Sequentially optimal mechanisms. Review of Economic Studies 73(4): 1085–1111.

    Article  MathSciNet  MATH  Google Scholar 

  • Sower VE, Savole MJ (1993). Are acceptance sampling and SPC complementary or incompatible. Quality Progress 26(9): 85–89.

    Google Scholar 

  • Spulber DF (1988). Optimal environmental regulation under asymmetric information. Journal of Public Economics 35(2): 163–181.

    Article  MathSciNet  Google Scholar 

  • Srinidhi B, Balachandran KR (1996). Strategic positioning and cost management along various quality dimensions. International Journal of Quality Science 1(2): 8–25.

    Article  Google Scholar 

  • Starbird SA (2001). Penalties, rewards, and inspection: Provisions for quality in supply chain contracts. Journal of the Operational Research Society 52(1): 109–115.

    Article  MATH  Google Scholar 

  • Stratton SD (2004). The application of lean thinking to pharmaceutical quality systems, defining the FDA as the customer. Dissertation, California State University. Suzhou City Food and Drug Administration. Suzhou pharmaceutical producing enterprises classified management regulations. Retrieved May 16, 2013, http: //wmdw.jswmw.com/home/content/?3954–1168763.html.

    Google Scholar 

  • Tzavara D, Héritier A (2012). Quality and environmental regulation: Verifying compliance along the supply chain. Business and Politics 14(2): 1–22.

    Article  Google Scholar 

  • International Society for Pharmaceutical Engineering. What is GMP. https: //www.ispe.org/initiatives/regulatoryresources/gmp/what–is–gmp.

  • Zhang MM, Zhang JL, Cheng TCE, Sallan JM, Hua GW (2018). Which inspection approach is better to prevent drug fraud: announced or unannounced? Journal of Systems Science and Complexity. Forthcoming.

    MATH  Google Scholar 

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Acknowledgements

We thank the anonymous reviewers for their helpful comments on our paper. This work was supported in part by the National Natural Science Foundation of China (grant numbers 71390334 and 71132008) and the Program for New Century Excellent Talents in University (NCET-13-0660).

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Correspondence to Manman Zhang.

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Manman Zhang received the B.Sc. degree from Qufu Normal University, Shandong, China in 2012. She is currently a Ph.D. student at Beijing Jiaotong University, Beijing, China. Her current research interests include quality management and supply chain management.

Juliang Zhang received the M.Sc. degree from Qufu Normal University, Shandong, China in 1998, and the Ph.D. degree from the Academy of Mathematics and Systems Science, Chinese Academy of Sciences, Beijing, China in 2001. He is currently a professor of supply chain and logistics in Beijing Jiaotong University, Beijing, China. He is a member of IEEE, a member of the Teaching Guidance Committee of Logistics Management and Engineering of the Ministry of Education. He is an active researcher and has published over 100 papers in the past ten years. His currently research interests include supply chain management, logistics, operations research, and so on.

T.C.E. Cheng received the B.Sc. degree from the University of Hong Kong, Hong Kong, China in 1979, the M.Sc. degree from the University of Birmingham, U.K. in 1980, the Ph.D. and Sc.D. degrees from the University of Cambridge, U.K. in 1984 and 2007, respectively. He is currently Chair Professor of Management and Dean of the Faculty of Business, and Fung Yiu King-Wing Hang Bank Professor in Business Administration in The Hong Kong Polytechnic University. He was rated as the most prominent author in Operations Management research in Asia over 2001–2015. Also, he was named one of the “most cited scientists" in all fields, in computer science, in economics and business, and in engineering over 2008–2018. His currently research interests include e-business and e-commerce, information systems management, innovation and technology management, operations management, quality management, scheduling science, and supply chain management.

Guowei Hua received the B.Sc. degree from Shandong Normal University, Shandong, China in 1997, the M.Sc. degree from Beijing University of Chemical Technology, Beijing, China in 2006, and the Ph.D. degree from the Academy of Mathematics and Systems Science, Chinese Academy of Sciences, Beijing, China in 2009. He is currently a professor of logistics and supply chain, and Vice Dean of the School of Economics and Management, Beijing JiaotongUniversity, Beijing, China. He is the senior member of IEEE. His currently research interests include logistics and supply chain management, low-carbon operations management, logistics system optimization design, and so on.

Xiaojie Yan received the B.Sc. and Ph.D. degrees from Beijing Jiaotong University, Beijing, China in 2010 and 2017, respectively. She is a postdoctoral fellow in the Academy of Mathematics and Systems Science, Chinese Academy of Sciences, Beijing, China. Her current research interests include pricing and inventory management, coordination and cooperation in supply chains, game theory, and mechanism design.

Yi Liu received the B.Sc. degree from Shandong University, Shandong, China in 2012. He is currently a Ph.D. student at Beijing Jiaotong University, Beijing, China. His current research interests include pricing strategy, mechanism design, and optimal supervision in drug supply chains.

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Zhang, M., Zhang, J., Cheng, T. et al. The Effect of Unannounced Inspection on Prevention of Drug Fraud. J. Syst. Sci. Syst. Eng. 28, 63–90 (2019). https://doi.org/10.1007/s11518-018-5382-8

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