Marks H M
Department of the History of Science, Medicine and Technology, Johns Hopkins University, Baltimore, Md. 21205.
Am J Public Health. 1995 Jan;85(1):109-15. doi: 10.2105/ajph.85.1.109.
It has been argued that today's prescription drug market originated in the arbitrary acts of the US Food and Drug Administration (FDA), which in 1938 issued regulations creating a class of drugs that could be sold by prescription only. On the basis of the FDA's administrative records, I argue that the 1938 regulations on prescription drug labeling were initiated by industry and then agreed to by the FDA; that contemporaries understood and accepted the reasons for restricting the use of certain drugs; and that the subsequent evolution of these regulations is best understood as an FDA effort to limit industry abuses of the prescription labeling system. This decade-long war of position ended when drug manufacturers persuaded the US Congress to enshrine their version of prescription labeling in law in a highly politicized struggle over government's role in the economy.
有人认为，如今的处方药市场起源于美国食品药品监督管理局（FDA）的武断行为，该机构于1938年发布规定，设立了一类只能凭处方销售的药品。基于FDA的行政记录，我认为1938年关于处方药标签的规定是由行业发起，然后得到FDA认可的；当时的人们理解并接受了限制某些药物使用的原因；而这些规定随后的演变，最好理解为FDA为限制行业滥用处方标签系统所做的努力。这场长达十年的立场之争在药品制造商说服美国国会，在一场关于政府在经济中角色的高度政治化斗争中，将他们版本的处方标签写入法律时结束。
