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outside the United States, as they often are, the quality of the data and the important aspects of clinical-study acumen by the site investigators is often lacking. Important information about the drug may not be passed along and this can seriously impede the development process. In addition, corporate rapport with the site investigators may be lost and the important seeding of the market with experienced investigators with a product may not occur when contract organizations are involved and non-United States data is employed. However, there may be significant cost savings and increased patient accession with the CRO and foreign-study data approaches that may make their utilization advisable. Clearly a balanced program giving careful considerations to the limitations of CROs running the studies, providing statistical analysis, and complete monitoring services as well as CROs coordinating non-United States performed studies need to be carefully evaluated and balanced against the more traditional approaches to drug development. |
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IX. The Government and Drug Development |
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The influences of the federal government are pervasive in our society, from our tax structure to the actions of regulatory agencies. All aspects of industry, and especially the pharmaceutical industry, are greatly influenced. Some very manipulative politicians target the pharmaceutical industry as they target the rich in their rhetoric to pander to voters. But for the most part, there is a finely balanced tension between the Democrats representing more government and the Republicans representing less government and deregulation. This is, of course, a simplification, but one with historic justification. Clearly there is a trend against government as the provider of solutions. How the trend will develop in the short term is difficult to predict. Even with the progression away from government and regulation, the impact this trend may have on the pharmaceutical industry will remain substantial. The loosening of OSHA regulations and environmental impact statements are more likely than changes at the FDA. This is despite a lot of discussions by the new Republican congressional leadership regarding FDA. However, the specter of an unprotected public is a difficult political cry to oppose and one I believe not one readily taken on except for the most ardent of Republican zealots. The industry itself, especially the larger pharmaceutical companies, appears to support FDA rather vigorously. They operate successfully within its framework and, in a way, the FDA has become part of the process to limit competition and diminish the effectiveness of the smaller companies not able to compete against the more formidable pharmaceutical giants. Additionally, the FDA, especially at the scientific level, well serves industry, ensuring efficacy and safety and instilling |
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