1997. The FDA approved 121 drugs in 1997; a considerable amount compared to the 69 drugs approved in 1987. In the future, the FDA will take an average of 10 months to approve standard drugs and six months to approve priority drugs (Levy 17A). On the downside, this recent speedy approval process has caused the FDA to withdraw a significant number of drugs from the market. Sometimes dangerous drugs reach the market because there is no way of answering every question of safety. Doctors sometimes ignore warnings that come with drugs, as in the case of Duract (a painkiller withdrawn last year). Warnings were posted with the approval of Duract stating that it should never be prescribed for more than ten days, but many users suffered from side effects after they had been taking the drug too long. Even though Duract was only on the market for 11 months, doctors wrote 2.5 million prescriptions for it, and many did not heed the warnings (Rubin 1A). In the last three years, more drugs than ever have been approved, and more drugs than ever have been taken off the market. Between September 1997 and July 1998, the FDA withdrew five drugs from the market, after it had not withdrawn a drug since 1992 (Rubin 1A). To protect the public and still get drugs to the market quickly, the FDA must focus on enhancing drug safety requirements as much as on speeding approvals by increasing pre-approval testing and post-marketing monitoring. Efficient approval of new drugs is very promising for patients today, but the process must not short-cut safety.The recent fever over dietary supplements has raised concerns with many consumers and the government. Dietary supplements are pills, capsules and extracts from sources such as Chinese herbs and shark cartilage that are used to treat all sorts of ailments. These supplements can go on sale without any evidence that they work, even though some of them have been reported to be dangerous. In 1994, a law was ...
