Examples:
The FDA points to examples such as zidovudine (commonly known as AZT) to illustrate the accelerated approval of drugs for life-threatening diseases. AZT, administered in the treatment of AIDS, showed promising results early in its clinical trials. Consequently, the FDA stopped these clinical trials before they were scheduled to end, and allowed thousands of AIDS patients to receive the drug before it was formally approved. Final approval was granted in March of 1987, less than 4 months after it was submitted. Since then, many other drugs developed to treat AIDS have been approved in comparable, or even shorter review times.
Thalidomide was introduced in West Germany in 1956 as a sedative and a treatment for morning sickness. Shortly thereafter in 1961, thalidomide was identified as a human teratogen (causing fetal developmental malformations) and was taken off the market. Due to the slowness and caution of the FDA, thalidomide had not been approved in the United States before the drug's harmful effects were revealed. Recently, the FDA has been looking into approving thalidomide for the treatment of diseases such as leprosy, inflammatory disorders, and cachexia (weight loss and metabolic wasting) seen in patients with advanced AIDS. FDA approval of thalidomide for use under tight restrictions was granted on July 18, 1998.
However, examples can also be shown to prove that the FDA drug approval process can be slow. The group of drugs known as beta blockers is an example of where the FDA's drug approval process was found to be slow. Beta blockers have been used in Europe since the mid 1960s to treat high blood pressure, migraine headaches and also as a preventative measure against secondary heart attacks. However, the FDA had, by 1975, only one beta blocker approved for U.S. use. Many other beta blockers were not approved until the end of the seventies or later.