Meyer G F
AAC Consulting Group, Bethesda, Maryland, USA.
Transplant Proc. 1999 May;31(3A Suppl):10S-12S. doi: 10.1016/s0041-1345(99)00105-0.
In the November 1987 edition of the Journal of the Society of Clinical Pharmacology and Therapeutics, Dr Richard Weinshilboum of the Department of Pharmacology at the Mayo Clinic made the following observation: "The past half century has been a golden age for pharmacologic therapy. Fifty years ago there were no antibiotics: there were no antihypertensives; there were no antineoplastics; there were no antipsychotics; there were no antidepressants; and the list could go on and on. With the exception of a few effective drugs, the pharmacopeia of that time was filled with placebos. Our generation has witnessed the transformation of medicine. A transformation due in part to the development of drugs capable of controlling or curing diseases that have plagued mankind throughout human history." There is plenty of room for both the innovator and generic manufacturer in this market, but both sides need protection. The regulations adopted by the FDA for providing a safe and effective route to drug approvals will foster both sides while maintaining its primary purpose, assurance to the public that the products they consume have been adequately studied and appropriately applied.
1987年11月版的《临床药理学与治疗学学会杂志》上，梅奥诊所药理学系的理查德·温希尔鲍姆博士发表了如下观点：“过去的半个世纪是药物治疗的黄金时代。五十年前没有抗生素；没有抗高血压药；没有抗肿瘤药；没有抗精神病药；没有抗抑郁药；诸如此类，不胜枚举。除了少数几种有效药物外，当时的药典充斥着安慰剂。我们这一代人见证了医学的变革。这种变革部分归功于能够控制或治愈贯穿人类历史一直困扰着人类的疾病的药物的研发。”在这个市场中，创新者和仿制药制造商都有很大的发展空间，但双方都需要保护。美国食品药品监督管理局（FDA）为药物审批提供安全有效途径而采用的法规将促进双方发展，同时保持其主要目的，即向公众保证他们消费的产品已经经过充分研究并得到适当应用。
