Jan. 15, 2018 – The FDA is delaying until further notice the effective date of a Jan. 9, 2017, final rule describing the types of evidence that may be considered in determining a medical product’s intended use so it can consider the comments and a citizen petition already received on that rule and collect additional feedback based on this input until Feb. 5, according to a proposed rule to be published in the Federal Register Jan. 16. The final rule – which was primarily focused on tobacco products – introduced new language on intended use, including a “totality of the evidence” standard.

“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,” FDA Commissioner Scott Gottlieb, M.D., said in a Jan. 12 statement on the FDA decision. “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.”

Of the 15 comments that were received on the final rule, submitted by the drug and device industries, various associations, academia, and individual submitters, 13 addressed the types of evidence that could be considered in determining intended use. Several commenters raised legal concerns with the final rule, according to the FDA, including arguments that the rule:

• Violates the First Amendment by regulating truthful speech regarding lawful activity;
• Violates the due process clause of the Fifth Amendment to the extent that the types of evidence to be considered are not clearly defined;
• Unlawfully interferes with the practice of medicine; and
• Departs from relevant statutory text, legislative history, case law, and FDA past practices.

The totality of the evidence standard in the final rule was the subject of a Feb. 8, 2017, citizen petition filed on behalf of the Medical Information Working Group, the Pharmaceutical Research and Manufacturers of America and the Biotechnology Innovation Organization (http://bit.ly/2FDGnIh). The petition called for the rule to be stayed indefinitely and be reconsidered on two grounds:

• The final rule violated the fair notice requirements of the Administrative Procedures Act because it changed the definition of intended use by introducing a new, and overly broad totality of the evidence standard that is not found in the Food, Drug and Cosmetic Act; and
• The totality of the evidence standard is “a new and unjustified legal standard.”

“FDA has tentatively concluded … that the Agency needs additional time for further consideration,” the proposed rule states. “FDA continues to work diligently on the issues related to intended use rise dint he underlying rulemaking and remains committed to rulemaking on this issue.”

The proposed rule concludes that “based in part on the questions raised by the petition, we further delayed the effective date of the final rule until March 19, 2018, and reopened the docket to invite additional public comment on the rule.”

Gottlieb’s statement made it clear that in the interim, the agency is “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.”