And, yes, in the general practice of medicine, drugs are used for conditions other than those they were approved for. We must take all of these factors into account as we work with sponsors to try to make safe and effective products available to patients as quickly as possible. Unlike in other areas of FDA's work, there is no set formula or standard for a determination that a product is safe. Safety is a relative term. There is a continuum of uncertainty that is tolerated, depending on the seriousness of the illness.
Every single drug has side effects.
Sometimes these will be rare, and sometimes these will not be very serious. But for every drug that we approve, we have to balance the benefits of the drug against its risks. We need to make clear what the risks are, and communicate that information as effectively as possible to all involved. The majority of injuries and deaths in this country from medical products are from known side effects, not from the unexpected ones. Therefore, although it is important to evaluate FDA's standards in its premarket decision-making, it is also important to look at whether risks are managed throughout the health care delivery system and whether adequate safeguards are in place.