Abstract
The drug approval process in the United States has received much criticism in recent years. While some of the criticism may be warranted, the overall process has demonstrated its effectiveness in that very few drugs that reach the market are associated with safety problems. Changes in the process have also allowed the FDA to act more swiftly to halt or limit distribution of a drug after marketing has begun.
The discontinuation of the drug methaqualone is unique in that social awareness of its abuse potential instead of safety problems brought about its removal from legal distribution channels. the efforts of both pharmacists and physicians were every effective in, first, placing stricter controls on the drug and, second, finally achieving its reclassification into Schedule I.