Medical device and pharmaceutical companies achieve success via maximization of sales profits and increases in stock valuation. Boosting sales of existing products is critical to company success and commercial survival. However, physicians (and other prescribers) and healthcare institutions act as gatekeepers on drug sales. Therefore, pharmaceutical and device companies have developed deeply entrenched relationships with physicians and healthcare administrators and exert insidious and powerful effects on how therapeutic agents are disseminated globally. Achieving regulatory approval to market new drugs and devices is time-consuming and extremely expensive. Market expansion—promoting new uses or use in new patient populations for approved products—is an important strategy for most drug and device companies. Convincing physicians to prescribe products for unapproved, “off-label” uses is commonly pursued through a variety of tactics collectively termed “off-label marketing” or “misbranding,” a practice that is illegal in most global markets and unethical in healthcare.

错误:搜索内容不能为空,请输入英文关键词
错误:关键词超出字数限制,请精简
高级检索

Ethics of Off-Label Marketing of Drugs: Patient Safety Versus Commercial Profits

  • Preetma Kooner,
  • Gail Van Norman

摘要

Medical device and pharmaceutical companies achieve success via maximization of sales profits and increases in stock valuation. Boosting sales of existing products is critical to company success and commercial survival. However, physicians (and other prescribers) and healthcare institutions act as gatekeepers on drug sales. Therefore, pharmaceutical and device companies have developed deeply entrenched relationships with physicians and healthcare administrators and exert insidious and powerful effects on how therapeutic agents are disseminated globally. Achieving regulatory approval to market new drugs and devices is time-consuming and extremely expensive. Market expansion—promoting new uses or use in new patient populations for approved products—is an important strategy for most drug and device companies. Convincing physicians to prescribe products for unapproved, “off-label” uses is commonly pursued through a variety of tactics collectively termed “off-label marketing” or “misbranding,” a practice that is illegal in most global markets and unethical in healthcare.