Bakke O M, Wardell W M, Lasagna L
Clin Pharmacol Ther. 1984 May;35(5):559-67. doi: 10.1038/clpt.1984.78.
Since the modern era of drug regulation began in the early 1960s, fewer new drugs have been approved for marketing in the United States than in the United Kingdom. We examined whether information can be obtained about the relative safety of higher and lower introductory rate policies by comparing each country's record of drugs that have been discontinued (removed from the market, withdrawn, or whose licenses were allowed to lapse) while a question of safety existed. We have compiled a list of both older (approved before 1964) and newer (approved in 1964 or later) chemical entities discontinued in the last two decades. With the aforementioned broad criteria to define "discontinuation," and to assess whether a question of safety was involved, our study showed that a total of 24 chemical entities have been discontinued in the United States or the United Kingdom. Nearly half (10 drugs) were products that had been approved in both countries, while the remainder (drugs that had been exclusively available in one country or the other) consisted of four drugs in the United States and 10 in the United Kingdom. Among the drugs introduced during the last two decades, five have been discontinued in the United States and eight in the United Kingdom. Each country's record of discontinuations has been remarkably similar for drugs introduced after 1974: Four have been discontinued in the United States and three in the United Kingdom. Since drugs discontinued while a safety question existed represent only 2% of the new chemical entities introduced, it appears that drugs that reach the market under the prevailing regulatory systems are seldom associated with unacceptable toxicity.
自20世纪60年代初现代药品监管时代开始以来，在美国获批上市的新药数量少于英国。我们通过比较每个国家在存在安全问题时已停产（从市场上撤下、撤回或其许可证失效）的药品记录，研究是否能够获取有关较高和较低引入率政策相对安全性的信息。我们编制了一份过去二十年中停产的旧化学实体（1964年之前获批）和新化学实体（1964年或之后获批）的清单。根据上述定义“停产”以及评估是否涉及安全问题的宽泛标准，我们的研究表明，在美国或英国共有24种化学实体已停产。近一半（10种药物）是在两国均获批的产品，其余（仅在一个国家上市的药物）包括美国的4种药物和英国的10种药物。在过去二十年中引入的药物中，有5种在美国已停产，8种在英国已停产。1974年之后引入的药物在每个国家的停产记录非常相似：美国有4种已停产，英国有3种已停产。由于在存在安全问题时停产的药物仅占引入的新化学实体的2%，因此在现行监管体系下进入市场的药物似乎很少与不可接受的毒性相关。
