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:
“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)
“Reckoned physiologically, everything ugly weakens and afflicts man. It recalls decay, danger, impotence; he actually suffers a loss of energy in its presence. The effect of the ugly can be measured with a dynamometer. Whenever man feels in any way depressed, he senses the proximity of something “ugly.” His feeling of power, his will to power, his courage, his pride—they decline with the ugly, they increase with the beautiful.”
—Friedrich Nietzsche (1844–1900)
“Mix salt and sand, and it shall puzzle the wisest of men, with his mere natural appliances, to separate all the grains of sand from all the grains of salt; but a shower of rain will effect the same object in ten minutes.”
—Thomas Henry Huxley (1825–95)