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:
“While man can still his body keep
Wine or love drug him to sleep,
Waking he thanks the Lord that he
Has body and its stupidity....”
—William Butler Yeats (1865–1939)
“The conservative assumes sickness as a necessity, and his social frame is a hospital, his total legislation is for the present distress, a universe in slippers and flannels, with bib and papspoon, swallowing pills and herb-tea.”
—Ralph Waldo Emerson (1803–1882)
“There is no calamity which a great nation can invite which equals that which follows a supine submission to wrong and injustice and the consequent loss of national self-respect and honor, beneath which are shielded and defended a people’s safety and greatness.”
—Grover Cleveland (1837–1908)