The Competitive Status of the U.S. Pharmaceutical Industry The Influences of Technology in Determining International Industrial Competitive Advantage (1983) / Chapter Skim
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Pages 1-6
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The most critical of these decisions involves investments in discovery of new patentable drugs, yet basic pharmaceutical research performed today may well not produce marketed products within this century, and even drugs now being synthesized will on average not be introduced into the United States until the mid-1990s. As a consequence, deteriorations now occurring in the relative innovative abilities of American pharmaceutical firms will not be visible in product markets for several years and not fully felt for as long as two decades.
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shares of major markets to Europe during the 1950s represented the recovery of those war-damaged economies to normal levels of output rather than any faltering of American economic achievement. Likewise, the gradual diffusion overseas of production by those industries that extensively use unskilled labor has been interpreted as the basic consequence of free trade and represents efficient reallocation of resources.
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Thus current research efforts provide a forecast of future sales, earnings, and jobs in the industry. By examining different segments of the innovation proces§-from RHO expenditure, to drugs entering clinical trials, to marketed drugs, to sales and market structure for new drugs -- the existing and expected future competitive patterns may be simultaneously compared.
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boundaries, a decline wholly unmatched in other segments of the chemical industry. Foreign non-tariff trade barriers such as discriminatory safety regulations and pricings by public health authorities are apparently the predominant cause of this divergent trend.
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OPTIONS FOR AMERICAN POLICY The study identifies a variety of policy options to counteract the causes of decline in the competitive position of the United States pharmaceutical firms. Trade Options FDA policy prohibiting the export of unapproved new drugs, and thus requiring United States companies to manufacture these products abroad, should be revised by regulation to permit the export of pharmaceutical chemicals for such use.
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Adoption of these recommendations would expedite the IND and NDA review process, thus reducing the size of the investment needed to develop new pharmaceutical products and increasing the return on such investment. Improvements in the drug approval process can be made without any reduction in public health protection and can be expected to result in more rapid availability of important new drugs to combat serious diseases for which effective drugs are not currently available.
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