Effect
The Kefauver Harris Amendment strengthened the U.S. Food and Drug Administration's control of experimentation on humans and changed the way new drugs are approved and regulated. Before the Thalidomide scandal in Europe, U.S. drug companies only had to show their new products were safe. After the passage of the Amendment, an FDA New Drug Application (NDA) would have to show that a new drug was both safe and effective (previously the 1938 Food, Drug and Cosmetic Act was the main law that regulated drug safety). Informed consent was required of patients participating in clinical trials, and adverse drug reactions were required to be reported to the FDA.
The Drug Efficacy Study Implementation was begun to classify all pre-1962 drugs that were already on the market as either effective, ineffective, or needing further study.
Estes Kefauver considered the Amendment his "finest achievement" in consumer protection.
Louis Lasagna, then a prominent clinical pharmacologist at the University of Rochester, advised Congress about the proper conduct of clinical research during the 1962 hearings leading up to passage of the Amendment.
The law also exempted from the "Delaney clause" (a 1958 amendment to the Food, Drugs, and Cosmetic Act of 1938) certain animal drugs and animal feed additives shown to induce cancer, but which left no detectable levels of residue in the human food supply.
Read more about this topic: Kefauver Harris Amendment
Famous quotes containing the word effect:
“Whenever any form of government shall become destructive of these ends, it is the right of the people to alter or to abolish it, & to institute new government, laying it’s foundation on such principles & organising it’s powers in such form, as to them shall seem most likely to effect their safety & happiness.”
—Thomas Jefferson (1743–1826)
“The attention of those who frequent the camp-meetings at Eastham is said to be divided between the preaching of the Methodists and the preaching of the billows on the back side of the Cape, for they all stream over here in the course of their stay. I trust that in this case the loudest voice carries it. With what effect may we suppose the ocean to say, “My hearers!” to the multitude on the bank. On that side some John N. Maffit; on this, the Reverend Poluphloisboios Thalassa.”
—Henry David Thoreau (1817–1862)
“Movies are one of the bad habits that corrupted our century. Of their many sins, I offer as the worst their effect on the intellectual side of the nation. It is chiefly from that viewpoint I write of them—as an eruption of trash that has lamed the American mind and retarded Americans from becoming a cultured people.”
—Ben Hecht (1893–1964)