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:
“I care not by what measure you end the war. If you allow one single germ, one single seed of slavery to remain in the soil of America, whatever may be your object, depend upon it, as true as effect follows cause, that germ will spring up, that noxious weed will thrive, and again stifle the growth, wither the leaves, blast the flowers, and poison the fair fruits of freedom. Slavery and freedom cannot exist together.”
—Ernestine L. Rose (1810–1892)
“Considered physiologically, everything ugly weakens and saddens man. It reminds him of decay, danger, impotence; it actually reduces his strength. The effect of ugliness can be measured with a dynamometer. Whenever anyone feels depressed, he senses the proximity of something “ugly.” His feeling of power, his will to power, his courage, his pride—they decline with ugliness, they rise with beauty.”
—Friedrich Nietzsche (1844–1900)
“A readiness to believe ill of others, before we have duly examined it, is the effect of laziness and pride. We are eager to find a culprit, and loath to give ourselves the trouble of examining the crime.”
—François, Duc De La Rochefoucauld (1613–1680)