Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA decision to seek additional time to reassess rule that would have changed longstanding practices for how the agency determined the ‛intended use’ of medical products

FDA News Release

• For Immediate Release: January 12, 2018

The FDA is committed to ensuring that we have the right policies and processes in place to fulfill our public health mission. This includes providing clear rules to medical product manufacturers about fundamental issues such as how the FDA will determine the intended use of a medical product. We heard concerns that the FDA’s final rule to amend the agency’s existing intended use regulations – put forward a year ago in January 2017 – wasn’t clear, and we’re committed to addressing this important issue.

This new language on intended use was included in an important, and otherwise largely non-controversial final rule notice that primarily addressed when tobacco products will be regulated as medical products, and more specifically which responsibilities for the regulation of tobacco products fall within our medical product centers versus our tobacco center. The new language on intended use relates to existing regulations that describe the types of evidence the FDA may consider to determine how a manufacturer intended for its product to be used by doctors and patients. This is a determination that can have significant implications for, among other things, how manufacturers communicate about and promote their products. How we determine intended use is an important issue that touches many fundamental aspects of the FDA’s work. The new language on intended use that was included in the final rule was not in the proposed rule.

By having clear and consistent rules appropriately grounded in public health policy that address this and related issues, the FDA is better able to maintain vigorous oversight and take enforcement actions when necessary. We need more time to consider the feedback we received and to make sure that our approach is guided by our public health mandate and to ensure the clarity of our rules on the subject. That’s why today we proposed to delay, until further notice, the effective date of those portions of the final rule that would have revised the FDA’s existing regulations describing the types of evidence that may be considered in determining a medical product’s intended uses.

By delaying implementation of these portions of the final rule we are not creating new policy, but instead reverting to the agency’s existing and longstanding regulations and interpretations on determining intended use for medical products. These are the same regulations and interpretations that have been in effect for decades.

We’re also making sure that the tobacco-related portions of the final rule will go into effect. So we’ve decoupled the intended use language from the tobacco part of the rule. We remain committed to rulemaking on the subject of intended use, and to an open and public process regarding the substance of the rule. In order to allow time to review comments received on the proposal to delay the March 19, 2018 effective date of the portion of the rule that related to intended use, and to prepare and publish a final rule effectuating the proposed delay, the agency has opened a comment period that will remain open until February 5, 2018.

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.