Abstract
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.
Full text
PDF
Images in this article
Selected References
These references are in PubMed. This may not be the complete list of references from this article.
- Lasagna L. Congress, the FDA, and new drug development: before and after 1962. Perspect Biol Med. 1989 Spring;32(3):322–343. doi: 10.1353/pbm.1989.0024. [DOI] [PubMed] [Google Scholar]
- Soumerai S. B., McLaughlin T. J., Avorn J. Improving drug prescribing in primary care: a critical analysis of the experimental literature. Milbank Q. 1989;67(2):268–317. [PubMed] [Google Scholar]
- Swann J. P. FDA and the practice of pharmacy: prescription drug regulation before the Durham-Humphrey Amendment of 1951. Pharm Hist. 1994;36(2):55–70. [PubMed] [Google Scholar]
- Wardell W. M. Patients' needs in drug development and regulation. Ann N Y Acad Sci. 1981;368:187–202. doi: 10.1111/j.1749-6632.1981.tb15448.x. [DOI] [PubMed] [Google Scholar]
- Wilkes M. S., Doblin B. H., Shapiro M. F. Pharmaceutical advertisements in leading medical journals: experts' assessments. Ann Intern Med. 1992 Jun 1;116(11):912–919. doi: 10.7326/0003-4819-116-11-912. [DOI] [PubMed] [Google Scholar]