What is the Role of the US Food and Drug Administration (FDA) and Its CAM Determinations?
Let’s look at what the FDA does, so that when you hear that a drug has been approved by the FDA, you’ll know what it means. Does it mean that the drug is effective for all patients? No! The FDA is charged with answering questions about the safety and efficacy of the drug. These two words are very important. Some safety rules are limited both in time and in how the evidence is collected; so, although these rules do establish safety to the standards applied, the FDA does not have a “crystal ball.” The FDA is inappropriately criticized for not being able to anticipate future side effects of a drug, even though the rules the FDA functions under do not require investigation into these side effects. The FDA is asked to use a particular timeframe, to examine data in a prescribed way, and to determine whether a drug is safe within those real constraints. The FDA does those tasks well. The FDA is also asked to conclude if a drug is efficacious: Does it really work? Efficacy means that in a cont
