Unapproved drugs in the United States and the Food and Drug Administration.

Abstract:

:Despite more than a century of evolving federal legislation, there remain many unapproved drugs on the United States (US) market. This article reviews the history of drug approval in the US, beginning with the landmark Pure Food and Drug Act of 1906, through to the development of the US Food and Drug Administration (FDA). The Pure Food and Drug Act of 1906 was the first comprehensive federal legislation covering drug regulation. Intervening legislation, such as the Federal Food, Drug, and Cosmetic Act of 1938 and Kefauver-Harris Amendments in 1962, was later instituted. In June 2006, a century after the development of the FDA as an enforcement body, an initiative was undertaken to remove unapproved drugs from the marketplace. The Marketed Unapproved Drugs-Compliance Policy Guide outlines enforcement policies aimed at efficiently and rationally bringing all unapproved and illegally marketed drugs into the approval process, or discontinuing their manufacture, distribution, and sale. The FDA has been actively pursuing control of unapproved drugs in recent years, with an approach concentrating on drug safety to ensure optimal public health and consumer protection.

journal_name

Adv Ther

journal_title

Advances in therapy

authors

Nasr A,Lauterio TJ,Davis MW

doi

10.1007/s12325-011-0059-4

subject

Has Abstract

pub_date

2011-10-01 00:00:00

pages

842-56

issue

10

eissn

0741-238X

issn

1865-8652

journal_volume

28

pub_type

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