For more detailed historical accounts, see RegierCornelius C., “The Struggle for Federal Food and Drugs Legislation,”Law and Contemporary Problems (December 1933), pp. 3–4; BlackJohn B. (ed.), Safeguarding the Public: Historical Aspects of Medicinal Drug Control (Baltimore: The Johns Hopkins Press, 1970); and DowlingHarry F., Medicines for Man (New York: Alfred A. Knopf, 1970).
2.
The details of the Kefauver hearings are contained in U.S. Congress, Senate, Judiciary Committee, Administered Prices: Drugs, (Washington, D.C.: Government Printing Office, 1961), especially Chapters 6–15. A more popularized version of the Kefauver hearings and the subsequent congressional debate leading to the 1962 amendments may be found in Richard Harris, The Real Voice (New York: Macmillan, 1964).
3.
A more complete account of drug regulation and its impacts on both the drug development process and the conduct of medical practice is contained in WardellWilliam M.LasagnaLouis, Regulation and Drug Development (Washington, D.C.: American Enterprise Institute for Policy Research, 1975). Many of the ideas discussed in this section of the paper are based on the more comprehensive discussion in this book.
4.
Ibid, p. 138.
5.
New drug products are traditionally classified into the following four categories; new chemical entities, duplicate products, compounded products, and alternate dosage forms. New chemical entities are the most unique new products and those which achieve the greatest degree of chemical differentiation.
6.
ClymerHarold A., “The Economics of Drug Innovation,” in PernarowskiM.DarrachM. (eds.), The Development and Control of New Drug Products (Vancouver: University of British Columbia, 1972).
7.
SchneeJerome E., “Development Costs: Determinants and Overruns,”Journal of Business, Vol. 45, No. 3 (July 1972), pp. 347–374.
8.
HansenRonald W., “The Pharmaceutical Development Process: Estimates of Current Development Costs and Times and the Effects of Regulatory Changes,”University of Rochester, Center for Research in Government Policy and Business, Working Paper GPB 77-10 (July 1978), p. 23.
9.
PeltzmanSam, Regulation of Pharmaceutical Innovation: The 1962 Amendments (Washington, D.C.: American Enterprise Institute for Public Policy Research, 1974), p. 81.
10.
Ibid, p. 82.
11.
Clymer, op. cit., p. 124.
12.
SchwartzmanDavid, Innovation in the Pharmaceutical Industry (Baltimore: The Johns Hopkins University Press, 1976), pp. 136–61.
13.
WardellWilliam M., “Introduction of New Therapeutic Drugs in the United States and Great Britain: An International Comparison,”Clinical Pharmacology and Therapeutics, Vol. 14 (1973), pp. 773–90. In a 1975 update of his study, Wardell concluded that the gap between the U.S. and the U.K. is closing. He attributes this progress, in part, to a more enlightened regulatory approach in the U.S. since 1972. See WardellLasagna, op. cit. pp. 109–23.
14.
LasagnaLouisWardellWilliam M., “The Rate of New Drug Discovery,” in HelmsRobert (ed.), Drug Development and Marketing (Washington, D.C.: American Enterprise Institute for Public Policy Research, 1975), pp. 155–64.
15.
ClymerHarold A., “The Economic and Regulatory Climate—U.S. and Overseas Trends,” in Helms, op. cit., pp. 137–154.
16.
The various hypotheses regarding the relationship between firm size and innovation are summarized in SchererF., Industrial Market Structure and Economic Performance (Chicago: Rand McNally, 1970), pp. 353–54.
17.
MansfieldEdwin, Industrial Research and Technological Innovation (New York: W. W. Norton, 1968), pp. 38–40; and GrabowskiHenry G., “The Determinants of Industrial Research and Development: A Study of the Chemical, Drug, and Petroleum Industries,”Journal of Political Economy (March/April, 1963), pp. 292–305.
18.
SchneeJerome E., “Innovation and Discovery in the U.S. Ethical Pharmaceutical Industry,” in MansfieldE.RapoportJ.SchneeJ.WagnerS.HamburgerM., Research and Innovation in the Modern Corporation (New York: W. W. Norton, 1971), Chapter 8; and ComanorWilliam S., “Research and Technical Change in the Pharmaceutical Industry,”Review of Economics and Statistics (May 1965), pp. 182–90.
19.
VernonJohnGusenPeter, “Technical Change and Firm Size: The Pharmaceutical Industry,”Review of Economics and Statistics, Vol. 56 (August 1974), pp. 294–302; and Schwartzman, op. cit., pp. 83–102.
20.
GrabowskiHenry G., Drug Regulation and Innovation (Washington, D.C.: American Enterprise Institute for Public Policy Research, 1976), pp. 55–59.
21.
More comprehensive discussions of proposals for modifying U.S. drug regulation are contained in WardellLasagna, op. cit. (footnote 3), pp. 143–60; and Grabowski, op. cit., pp. 75–82.
