Drug Efficacy Study Implementation (DESI) was a program begun by the
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
(FDA) in the 1960s after the requirement (in the
Kefauver-Harris Drug Control Act) that all
drug
A drug is any chemical substance that causes a change in an organism's physiology or psychology when consumed. Drugs are typically distinguished from food and substances that provide nutritional support. Consumption of drugs can be via insuffla ...
s be efficacious as well as safe, was made part of US law. The DESI program was intended to classify all pre-1962 drugs that were already on the market as either effective, ineffective, or needing further study.
[Pharmacy Today. August 2008.]
FDA aims to remove unapproved drugs from market: Risk-based enforcement program focuses on removing potentially harmful products
/ref> The Drug Efficacy Study Implementation (DESI) evaluated over 3,000 separate products and over 16,000 therapeutic claims. By 1984, final action had been completed on 3,443 products; of these, 2,225 were found to be effective, 1,051 were found not effective, and 167 were pending.
One of the early effects of the DESI study was the development of the Abbreviated New Drug Application
An Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug approval for an existing licensed medication or approved drug.
The ANDA is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drug ...
(ANDA).
See also
* Estes Kefauver
Carey Estes Kefauver (;
July 26, 1903 – August 10, 1963) was an American politician from Tennessee. A member of the Democratic Party, he served in the U.S. House of Representatives from 1939 to 1949 and in the Senate from 1949 until his d ...
* Federal Food, Drug, and Cosmetic Act
The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of f ...
* Inverse benefit law
The inverse benefit law states that the ratio of benefits to harms among patients taking new drugs tends to vary inversely with how extensively a drug is marketed. Two Americans, Howard Brody and Donald Light, have defined the inverse benefit law ...
* Regulation of therapeutic goods
The regulation of therapeutic goods, defined as drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are reg ...
References
External links
* National Academies of Sciences archives.
The Drug Efficacy Study of the National Research Council’s Division of Medical Sciences, 1966-1969
* Chhabra R, Kremzner ME, Kiliany BJ. FDA policy on unapproved drug products: past, present, and future. Ann Pharmacother. 2005 Jul-Aug;39(7-8):1260-4.
American medical research
Pharmaceuticals policy
Food and Drug Administration
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