- For Immediate Release:
- Statement From:
Robert M. Califf, M.D., MACC
Commissioner of Food and Drugs - Food and Drug Administration
Ensuring the availability of innovative interventions for people is a shared priority for both the Centers for Medicare & Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA). We recognize the important and related – but different – roles of our respective agencies and know that CMS and FDA decisions have an outsized impact on the U.S. health care system, as well as implications for the rest of the world.
Underpinning both of our agencies’ work is the unwavering commitment to use reliable data to ensure that effective treatments are made available to patients. The FDA’s decision to approve a new medical product is based on a careful evaluation of the available data and a determination that the medical product is safe and effective for its intended use. In some instances, the FDA has the authority to require additional studies after approval to provide additional information regarding the anticipated clinical benefit for the medical product.
CMS can conduct its own independent review to determine whether an item or service should be covered nationally by Medicare, including examining whether it is reasonable and necessary for use in the Medicare population.
The work of both of our agencies is critical to ensure that medical products are available to people across the country.
We recognize the impact these decisions have on people with serious and life-threatening conditions and their loved ones. We share a common goal of wanting to advance the development and availability of innovative medical products. Our agencies remain committed to using our distinct set of authorities to ensure the continued availability of medical products that meet our respective standards to care for the people we serve.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
- FDA Office of Media Affairs