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creased research investments by about 13% per year per approved product while time lines have increased 5 years in two decades and the economic risks of failure have increased [98]. |
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The development of new prescription medications offers our greatest hope of controlling human suffering and the costs associated with diseases of aging. With nearly 17% of its revenue devoted to R & D, the U.S. pharmaceutical industry continues to maintain international leadership in finding solutions to health problems. |
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Cost-containment and product-liability considerations have become more controlling than innovation considerations in some aspects of new drug development. Although cost containment activities and product liability have no doubt been responsible for some portion of the decline in research productivity, the precise extent of their contribution to that decline is unknown [99]. Government-forced rebates and discounts, coercive pressures from the managed care industry, and the increasing preference for generics will foster intensified competition and squeeze revenues. |
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In the future, the therapies available to patients will be determined by decisions based on pharmacoeconomic and outcome-oriented research. The industry is already curbing prices through involvement with managed care programs and the increased competition from generics and me-too products. The specter of price regulation, government controls, and other market manipulations are expected to reduce industry profitability and consequently reduce investment in new drug research. Today's profits are an inaccurate measure of the continued viability of the pharmaceutical industry's innovative process. They merely show that the innovative process of the last decade was |
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| Table 4 The Future: How to Nurture Drug Development | | Accelerate drug development/approval | | Reduce product liability disincentives |  |
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Continue harmonization of drug approval procedures between countries |
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Foster favorable environment for R & D collaboration and greater emphasis on interdisciplinary research |
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| | Eliminate trade barriers via multilateral trade negotiations | | Reconsider patent laws | | Co-marketing, merging, strategic alliances | | Adapted from Ref. [100]. |
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