How are pharmaceuticals and medical devices regulated?
Under the terms of the Food, Drug and Cosmetics Act (the Act), the Food and Drug Administration (FDA) is required to ensure that new drugs are both safe and effective before they can be sold in the United States. The Act gives FDA a great deal of discretion to determine what it means for a drug to be “safe” and “effective,” however, because most medicines are actually toxic if taken at inappropriate doses. In order to treat or cure many diseases, it is necessary to use drugs that may have substantial side effects, so the Act leaves it up to FDA to balance the need for new medicines against the known side effects of those products. Most medical devices (a category that includes such things as pacemakers, arterial stents, and diagnostic tools, such as X-ray and MRI machines) are regulated in a similar fashion. In order to generate data on safety and efficacy, drug manufacturers conduct a broad variety of pre-clinical tests on laboratory animals, and then three phases of graduated clinica
