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:
“Human knowledge and human power meet in one; for where the cause is not known the effect cannot be produced. Nature to be commanded must be obeyed; and that which in contemplation is as the cause is in operation as the rule.”
—Francis Bacon (1560–1626)
“This is the great truth life has to teach us ... that gratification of our individual desires and expression of our personal preferences without consideration for their effect upon others brings in the end nothing but ruin and devastation.”
—Hortense Odlum (1892–?)
“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)