cribed off-label. In addition, Aspirin is widely used to help heart disease, and pediatric patients often receive off-label prescriptions (FDA reforms healthy 14A).It is estimated that 80% of prescription drugs given to children are not tested to see if they are safe for young users. Pediatricians have been forced to guess the proper dosages, even though children react to and metabolize drugs differently than adults (Lewis 145). The FDA has offered incentive to drug companies in the past to seek pediatric labeling approval of their drugs, but few of the companies bothered. Only 20% of the drugs licensed by the FDA since 1962 have been approved for children (Lewis 155). The pharmaceutical companies would rather not test their drugs on children because of a number of risks and added expenses (a controlled drug study costs a company about $30,000 per participating child!). Now the FDA has made modifications that will ensure the safety of drugs given to children. The Clinton Administration passed a bill in November 1998 that requires companies to test their drugs on children if they expect them to be taken by more than 100,000 young patients a year (Pear 1A). The FDA has the power to enforce this new requirement by suing drug companies and seeking fines from them for noncompliance, but they do not have the power to remove the drugs from the market. It is estimated that these new requirements for testing drugs on children will cost the drug industry $13.5 million to $21 million a year. However, this price should not mean much for the drug industry, which generates more than $60 billion a year in U.S. sales alone (Lewis 157).Today the process of FDA drug approval is so accelerated that drugs are entering the market at an unprecedented rate. The average period of time for FDA review dropped from 30 months in 1992 to 15 months in 1997. The approval time for brand-new drugs averaged about 15 months in 1996 and dropped to 12 months in...
