Hostname: page-component-8448b6f56d-m8qmq Total loading time: 0 Render date: 2024-04-23T08:23:17.085Z Has data issue: false hasContentIssue false
  • English
  • Français

The Evolution of Federal Regulation of Human Drugs in the United States: An Historical Essay

Published online by Cambridge University Press:  06 January 2021

Peter B. Hutt
Peter B. Hutt*
Affiliation:
Washington, D.C. law firm of Covington and Harvard Law School
Get access Rights & Permissions [Opens in a new window]

Extract

Drug development prior to 1800 was based almost completely on observational trial and error. The earliest known exception was a controlled drug trial conducted by James Lind in 1747 on an English ship to show the effectiveness of citrus fruit in the treatment of scurvy. Clinical tests, but not concurrent comparative trials, were conducted by Charles Maitland in 1722 in London to show the effectiveness of variolation in preventing smallpox, and a controlled drug trial was conducted by Edward Jenner in London in 1796 to show the effectiveness of material taken from cowpox sores of young milkmaids (later called smallpox vaccine) in preventing smallpox. In 1775, William Withering learned from an elderly woman herbalist in Shropshire, England about her use of the Foxglove plant (whose active ingredient Withering later determined to be digitalis) in treating heart disease, and in 1785 published the results of his treatment of 158 patients with the drug, but he did not conduct a controlled study.

Type
Articles
Information
American Journal of Law & Medicine , Volume 44 , Issue 2-3: Symposium - The 21st Century Cures Act: A Cure for the 21st Century? , May 2018 , pp. 403 - 451
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 2018

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

1 See Removal of Review and Reclassification Procedures for Biological Products Licensed Prior to July 1, 1972, 80 Fed. Reg. 38145, 38146 (proposed July 2, 2015) (to be codified at 21. C.F.R. pt. 601).

2 Daniel Carpenter, Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA 175 (2014).

3 See Administered Prices in the Drug Industry: Hearing Before the Subcomm. on Antitrust and Monopoly of the S. Comm. on the Judiciary, 85th Cong. 8139 (1957).

4 Administered Prices in the Drug Industry: Hearing Before the Subcomm. on Antitrust and Monopoly of the S. Comm. on the Judiciary, 85th Cong. 12108 (1957) (statement of Arthur S. Flemming, Secretary, U.S. Food & Drug Admin.)

5 Philip J. Hilts, Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation 105 (Alfred A. Knopf ed. 2003).

6 See Carpenter, supra note 2, at 139.

7 Administered Prices in the Drug Industry: Hearing Before the Subcomm. on Antitrust and Monopoly of the S. Comm. on the Judiciary, 85th Cong. 12120 (1957) (statement of Arthur S. Flemming, Secretary, U.S. Food & Drug Admin.).

8 Reauthorizations of PDUFA are referred to by their popular names as listed in Figure 13.

9 Nat'l Cancer Inst., Final Report of the National Committee to Review Current Procedures for Approval of New Drugs for Cancer and AIDS (1990).

10 See Hutt, Peter B., Philosophy of Regulation Under the Federal Food, Drug, and Cosmetic Act, 50 Food & Drug L.J. 101, 104 (1995)Google Scholar.