For both radiation products and any other form of drug or device, a patient is deliberately exposed to a potentially toxic ingredient because, in the concerted judgment of the patient and the physician, after weighing the risks and benefits of the therapy or diagnosis and of available alternatives, it is considered the most effective and beneficial procedure for the patient. Risks that would never be tolerated for individuals who are not suffering from disease become acceptable for the ill patient because the potential benefits outweigh the potential risks. For all medical products, needless or excessive exposure is never justified. Having accepted a certain level of risk, patients seek assurance that the drug or device is sufficiently reliable and that the health personnel administering the therapy are sufficiently competent.

Safety is not the only regulatory goal for radiation products or any other form of drug or device. Although the legislation enacted by Congress to regulate radiation products as well as other drugs and devices often focuses primarily upon safety, inherent in all of this legislation is the equally important goal of promoting new medical technology that will address the nation's important health needs. Many of our most serious diseases can effectively be treated in the future only through the development of new medicine, including radiation products, that will make major advances in diagnosis and therapy.

These twin goals for regulation of medical products—promoting safety and promoting technological advance—require a delicate balance. Overprotection against unsafe products will reduce technological advances, raise health care costs, and harm the public health. Overpromotion of technological advances could reduce safety protections and also harm the public health. Inevitably, regulators must balance safety, effectiveness, the need for important new medical products, the cost of complying with regulatory requirements, and access by patients to new therapies on a reasonable timetable.

THE CURRENT REGULATORY FRAMEWORK

How Society Regulates Health Care Delivery

Government regulation of pharmaceutical products, and of the health professionals who administer them, has a long and complex history. At the time our country was founded, there was very little regulation of either products or practitioners. Injured consumers could bring suit in the courts for damages caused by unsafe or ineffective medical products only under limited conditions; and neither licensure nor minimum training was necessary to practice medicine. State regulation of domestic drugs and federal regulation of imported drugs began in the mid-1800s, but premarket testing and approval was not a part of these early programs. The basic philosophy was that consumers should be prudent purchasers, scrutinizing the quality of the goods and services offered in an open market economy.



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