Since the 1960s, the Food and Drug Administration has been required to follow the standard that a drug must be effective as well as safe before it can be marketed.
Critics say the efficacy requirement requires huge expenditures by drug companies for testing.
They say it is also unnecessary, since patients and doctors are in a better position to evaluate how effective a drug is. In other words, let the market decide. Those familiar with the approval process report that research institutes conducting efficacy trials often produce conflicting data. The conclusion often drawn is that more studies are necessary. That means that drug companies must send more money to research institutes.