|How the FDA Reviews Drugs by Rachel Speigel|
The FDA regulates all foods and drugs sold in the United States. It is a public health agency that is part of the United States Department of Health and Human Services.
After the thalidomide disaster, legislators recognized that the drug approval process had to be more tightly controlled. Congress bolstered the FDA's regulatory powers by passing the Kefauver-Harris Drug Amendments Act in October 1962. As a result of this ruling, scientists had to prove that a drug was safe and effective before it could be sold to the American public.
Now, on average, the approval process for a drug takes eight years. FDA physicians, scientists, and other staff review test results from laboratory and animal experiments submitted by drug companies, and this information helps them decide whether the drug is safe enough to test in humans. Animal experimentation is useful, but it cannot always indicate what will happen in humans. For example, thalidomide is not a particularly potent teratogen in most animals, yet it is very dangerous for humans. The only animals that respond to the drug the way humans do -- with missing or shortened limbs -- are primates and a few breeds of rabbits.
When FDA officials conclude that a drug can be sold to the public, they determine what its label should include regarding directions for use, side effects, and warnings. Detailed information about the drug approval process is posted at the FDA website (see Additional Resources list in main story).