FDA Delays Controversial Intended Use Rule

Posted January 30, 2018

The Food and Drug Administration (FDA) has indefinitely delayed portions of a final rule that was intended to clarify when tobacco or tobacco-related products are regulated, but ultimately drew backlash from industry due to its inclusion of potentially far-reaching changes to the way the FDA assesses the intended use of drugs and medical devices.

The rule would have revised the types of evidence that may be considered in determining a medical product’s intended use, and therefore affected how manufacturers could discus off-label uses of their products. The FDA previously delayed the rule for one year following a petition from industry groups that alleged the FDA did not follow proper rulemaking procedures.

“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,” said FDA Commissioner Scott Gottlieb, in a statement. “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.””

At issue was revised language that appeared in the final rule, but was not included in the proposed rule. The language established a high “totality of evidence” standard for when “a manufacturer objectively intends that a drug introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than ones for which it is approved (if any), he is required, in accordance with section 502(f) of the Federal Food, Drug, and Cosmetic Act, or, as applicable, duly promulgated regulations exempting the drug from the requirements of section 502(f)(1), to provide for such drug adequate labeling that accords with such other intended uses."

According to the FDA, the decision to delay the intended use portions of the final rule “until further notice” did not constitute a new policy. Instead, the FDA will revert to its existing, “longstanding regulations and interpretations on determining intended use for medical products,” Gottlieb said.

The FDA is seeking comments on the proposed delay until Feb. 5. Comments can be submitted via www.regulations.gov.

Meanwhile, the final rule’s tobacco-related portions, which address when tobacco products will be regulated as medical products, will still go into effect on March 19. Gottlieb described those portions as “otherwise largely noncontroversial.”