es for drugs is a requirement that gives drug companies a certain time period to submit a supplemental application based on appropriate research to show that the unapproved use is safe and effective. Today, more than 100 million Americans take medications that were not intended for their ailments (Lewis 144). If the FDA approves a drug, it must be safe and effective, but they cannot possibly consider all uses. By not applying for approval of an off-label use, pharmaceutical companies do not have to spend millions of dollars on clinical trials or safety research, which allows them to keep more profits from an old drug (Lewis 153). In September 1997, the FDA recalled the drug fenfluramine after it had been widely prescribed with another drug as an off-label use, commonly referred to as fen-phen (a combination of fenfluramine and phentermine). The combination of the drugs has been found to often cause heart complications, and it lead to at least 70 deaths between 1974 and 1997. Doctors wrote millions of prescriptions for fen-phen without always giving a preliminary physical exam (Kerr 1). Though the drugs were really meant for those who needed to lose weight because of health risks, the off-label prescription was often given to those just looking to trim some pounds off. Now, the off-label combination of these drugs is unapproved but still legal. Pharmaceutical companies are currently urging congress to pass a law that would immunize them from any punitive damages if they sold their FDA-approved drugs for off-label uses (Hellmich 1A). This would create obvious problems for people taking drugs for off-label uses that could potentially be dangerous. Some say that this could lead to drug companies scamming the system, leading to more off-label catastrophes while they perform flawed studies and bury the unflattering reports. On the other hand, many off-label drug uses are extremely beneficial. Over 40% of all cancer drugs are pres...
