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Regulation of product safety design through product testing

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Abstract

The indirect regulation of product safety design through pre-market testing is common with pharmaceuticals and other products containing chemical ingredients. We model this problem as a three stage game in which the firm begins by designing safety, next the government supervises a testing process, and finally the firm markets the product if it is approved. We characterize and compare the Nash and the two leadership equilibria of this game, analyze the comparative statics of these solutions, and consider the effects of regulatory misbehavior. We show that the effects of regulatory misbehavior depend crucially the type of firm-regulator interaction.

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References

  • Bailey, M. R. 1972. “Research and Development Costs and Returns: The U.S. Pharmaceutical Industry.”Journal of Political Economy 80: 70–84.

    Google Scholar 

  • Beals, H., R. Craswell, and S. Salop. 1981. “The Efficient Regulation of Consumer Information.”Journal of Law and Economics 24: 491–539.

    Google Scholar 

  • Butters, G. 1983. “A Sequential Sampling Model of Advertising Substantiation.” Mimeo, FTC Bureau of Economics.

  • Calfee, J. E. 1991. “FDA Regulation: Moving Toward a Black Market in Information.” Presented at the American Enterprise Institute Annual Policy Conference, Washington, DC.

  • Campbell, T. S., Y-S Chan, and A.M. Marino. 1991. “Welfare and Product Testing by a Regulated Monopolist.”Journal of Regulatory Economics 3: 57–68.

    Google Scholar 

  • Caves, R. E., M. D. Winston, and M. A. Hurwitz. 1991. “Patent Expiration, Entry, and Competition in the U. S. Pharmaceutical Industry.” InBrookings Papers on Microeconomic Activity, edited by M. N. Bailey and C. Whinston.

  • Chan, Y-S and A. M. Marino. 1994. “Regulation of Product Safety Characteristics under Imperfect Observability.”Journal of Regulatory Economics 6: 177–195.

    Google Scholar 

  • Council on Competitiveness. 1991. “Council on Competitiveness Fact Sheet: Improving the Nation's Drug Approval Process.” Washington D. C.

  • Craswell, R. 1988. “Precontractual Investment as an Optimal Precaution Problem.”Journal of Legal Studies 17: 401–36.

    Google Scholar 

  • DiMasi, J. A., N. R. Bryant, and L. Lasagna. 1991. “New Drug Development in the United States from 1963 to 1990.”Clinical Pharmacology and Therapeutics 50: 471–486.

    Google Scholar 

  • Dranove, D. and D. Meltzer. 1991. “Does the FDA Accelerate or Delay the Introduction of Important New Drugs?” Northwestern University mimeo.

  • Grabowski, H. G., and J. M. Vernon. 1983.The Regulation of Pharmaceuticals. Washington D. C.: The American Enterprise Institute.

    Google Scholar 

  • Grabowski, H. G., J. M. Vernon and L. G. Thomas. 1978. “Estimating the Effects of Regualtion on Innovation: An International Comparative Analysis of the Pharmaceutical Industry.”Journal of Law and Economics 21: 133–164.

    Google Scholar 

  • Grossman, S. 1981. “The Informational Role of Warranties and Private Disclosure about Product Quality.”Journal of Law and Economics 24: 461–83.

    Google Scholar 

  • Kwerel, E. 1980. “Economic Welfare and the Production of Information by a Monopolist.”Bell Journal of Economics 11:505–18.

    Google Scholar 

  • Matthews, S., and A. Postlewaite. 1985. “Quality Testing andDisclosure.rdRand Journal of Economics 16: 328–40.

    Google Scholar 

  • Milgrom, P., and J. Roberts. 1986. “Relying on Information of Interested Parties.”Rand Journal of Economics 17: 18–32.

    Google Scholar 

  • Peltzman, S. 1987. “The Health Effects of Mandatory Prescriptions.”Journal of Law and Economics 30: 207–238.

    Google Scholar 

  • Siegal, J. and M. Roberts. 1991. “Reformong FDA Policy: Lessons from the AIDS Experience.”Regulation 14: 71–77.

    Google Scholar 

  • Temin, P. 1992. “Realized Benefits from Switching Drugs.”Journal of Law and Economics 35: 351–369.

    Google Scholar 

  • Ward, M. 1992. “Drug Approval Over-Regulation.” presented at the Cato Institute's Third Annual Regulation Conference, April 1992.

  • Ward, M. and D. Dranove. 1992. “The Vertical Chain of Research and Development in the Pharmaceutical Industry.” Northwestern University Working Paper.

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The author thanks D. Craswell, S. Dasgupta, T. Gilligan, J. Matsusaka, J. Ye, and M. Zupan. Benefit was also derived from two anonomous referees and seminar participants at the University of California, Riverside, and The University of Southern California. Generous research support was provided by the

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Marino, A.M. Regulation of product safety design through product testing. J Regul Econ 7, 255–276 (1995). https://doi.org/10.1007/BF01067097

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