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The pharmaceutical industry of the 1990s is facing increasing challenges. The race to new drug approval is now further complicated by increased cost-containment pressures and liability concerns. The expectation for pharmaceutical companies to economically develop safe and efficacious drugs that provide added value to the health care marketplace has caused pharmaceutical companies to reevaluate their drug development process. Among the many trends and events that are shaping the future of new drug development, several are paramount. This chapter identifies and analyzes emerging cost-containment and product liability trends that have impacted on the drug development process. It concludes with a look at how these factors might affect future drug development and patient access to new pharmaceuticals. |
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II. Product Liability Issues in Drug Development |
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Product liability continues to be the creature of social policy and has changed as society's value system has changed. Just as a certain morbidity/mortality risk for surgery is accepted, we accept some benefit versus risk from any drug. For example, xerostomia may be an acceptable price to pay for the drug of choice, deafness may not be. A striking risk/benefit example is the risk of bone marrow suppression with cytotoxic drugs in treating neoplastic diseases. Although bone marrow suppression can be life threatening, the disease is lethal, so we take and accept the risk. Part of industry's problem is that there are no guidelines outlining the concept of risk/benefit. The best case is for a product to be so uniquely life saving or beneficial that no prudent person could argue that the benefit/risk balance is not acceptable [1]. |
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Before 1970, relatively few product lawsuits were filed in the United States. Product liability litigation in the United States is rising, and in 1994, the pharmaceutical industry spent approximately 0.5% of total revenues just on legal fees [2]. That percentage is approximately double that spent by either the food or utilities industries [2]. Medical malpractice and product liability costs in the United States have increased from $900 million in 1974 to $9.2 billion in 1991 [3]. In 1992 there were 31,400 such cases, with roughly two out of five taking more than two years to resolve [4]. The increase is attributed to the belief that manufacturers should be strictly liable for all injuries associated with products, regardless of actual fault or consumer misuse. The courts have extended the liability of the manufacturer to include not only the actual consumer, but anyone who may be foreseeably affected by the product [5]. |
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Certain drug categories have been characterized as litogens, i.e., drugs causing lawsuits. The threat of enormous punitive damage awards has discour- |
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