Drug Legislation and Safety
In the United States, the Food and Drug Administration (FDA) is responsible for creating guidelines for the approval and use of drugs. The FDA requires that all approved drugs fulfill two requirements:
- The drug must be found to be effective against the disease for which it is seeking approval.
- The drug must meet safety criteria by being subject to extensive animal and controlled human testing.
Gaining FDA approval usually takes several years to attain. Testing done on animals must be extensive and must include several species to help in the evaluation of both the effectiveness and toxicity of the drug. The dosage of any drug approved for use is intended to fall within a range in which the drug produces a therapeutic effect or desired outcome.
The safety and effectiveness of prescription drugs in the U.S. is regulated by the federal Prescription Drug Marketing Act of 1987.
The Medicines and Healthcare products Regulatory Agency (MHRA) has a similar role in the UK.
Read more about this topic: Pharmacology
Famous quotes containing the words drug, legislation and/or safety:
“Upon entering my vein, the drug would start a warm edge that would surge along until the brain consumed it in a gentle explosion. It began in the back of the neck and rose rapidly until I felt such pleasure that the world sympathizing took on a soft, lofty appeal.”
—Gus Van Sant, U.S. screenwriter and director, and Dan Yost. Bob Hughes (Matt Dillon)
“But the wise know that foolish legislation is a rope of sand, which perishes in the twisting; that the State must follow, and not lead the character and progress of the citizen; the strongest usurper is quickly got rid of; and they only who build on Ideas, build for eternity; and that the form of government which prevails, is the expression of what cultivation exists in the population which permits it.”
—Ralph Waldo Emerson (1803–1882)
“Firm, united, let us be,
Rallying round our Liberty;
As a band of brothers joined,
Peace and safety we shall find.”
—Joseph Hopkinson (1770–1842)