The United States currently is using a regulatory framework for drugs and devices that was developed during the 20th century when iron lungs were still in use, the polio vaccine was just being discovered, genomics were just a science fiction dream, and personalized medicine meant your doctor made house calls. While the long standing requirements for assessing the safety and efficacy of new products remains the cornerstone for protecting and promoting public health, the stepwise addition of regulatory responsibilities has created an agency that is oriented to the type of products it regulates rather than the diseases they’re intended to treat.
Drugs were first regulated in 1938 when Congress passed the Federal Food Drug and Cosmetic Act, which established drug product safety standards. Since then, the law has been revised numerous times, adding additional categories of medical products to FDA’s jurisdiction and expanding its regulatory authority. In 1944, biological products, such as vaccines, came under FDA oversight as a result of Congress passing the Public Health Service Act. In 1962, Congress granted FDA authority to regulate the efficacy of new drugs, in addition to safety. In 1976, with the passage of the Medical Device Amendments, FDA was charged with assuring the safety and effectiveness of medical devices, including diagnostic products.
Congress has not modernized FDA’s organizational structure for medical products since the 1970s. The existing regulatory framework has been defined by a “divide and conquer" approach to oversight; separate centers within FDA regulate three major categories of medical products: drugs, devices, and biologics. This organization was appropriate for the science of that era; drug and device regulation involved little overlap and the separate FDA centers were able to regulate their respective products without needing to coordinate efforts.
The FDA’s product-oriented approach to regulating new treatments and products does not allow for the optimal use of its broad spectrum of expertise and can lead activities related to the same disease to be conducted in any number of different parts of the agency. This can result in inconsistent feedback and differences in how study designs and requirements are applied.
Advances in science and technology have led to treatment protocols that involve different types of medical products over the course of treating patients. In addition, many of these products are now being developed concurrently, such as drugs that require a diagnostic test to identify patients who are most likely to benefit. Having these products regulated within isolated portions of the FDA can lead to incongruent timelines that may result in development delays. …
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