In addition, the task force recommended that the FDA's postmarketing programs should be expanded to ensure that we are able to meet the challenges of the current regulatory and health care environment. This report indicates that medical mistakes are responsible for the deaths of up to 98,000 people every year. It is important to point out that the majority of injuries and deaths in the U.S. that are attributable to medical products are from known side effects, and not from unexpected ones. The findings of this report confirmed the findings of our earlier report. There is room for improvement.
Most medical products have inherent risks associated with their use, some greater than others.
As these products enter the market place it remains the FDA's responsibility to communicate the known risks to physicians, nurses, pharmacists, patients, consumers, and anyone else who may be affected by those risks or their management. And we must all be alert to previously unknown side effects or interactions with other drugs, foods, or dietary supplements, and prepared to communicate this new information to those involved with administration or use of the product. The entire health care delivery system must have adequate safeguards in place. This begins with the development, manufacture, and approval of a product, and continues with physician prescribing practices, pharmacy dispensing, and proper administration of the product to patients in a hospital setting, or at home by the patients themselves. Before marketing, FDA also strives to minimize certain risks by assessing potential name confusions or interactions.