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:
“Whoever grows angry amid troubles applies a drug worse than the disease and is a physician unskilled about misfortunes.”
—Sophocles (497–406/5 B.C.)
“Statecraft is soulcraft. Just as all education is moral education because learning conditions conduct, much legislation is moral legislation because it conditions the action and the thought of the nation in broad and important spheres of life.”
—George F. Will (b. 1941)
“Can we not teach children, even as we protect them from victimization, that for them to become victimizers constitutes the greatest peril of all, specifically the sacrifice—physical or psychological—of the well-being of other people? And that destroying the life or safety of other people, through teasing, bullying, hitting or otherwise, “putting them down,” is as destructive to themselves as to their victims.”
—Lewis P. Lipsitt (20th century)