On Friday, March 16th, the FDA published a notice in the Federal Register, stating that the effective date for the amendments related to intended use would be delayed indefinitely. In the notice, the FDA clarified that, 21CFR1100.5, added January 9, 2017 concerning the regulation of tobacco products, would still go into effect March 19, 2018.
The rule’s delay comes after continued criticism from industry groups regarding the clarity of the intended use portion of the rule. This regulation pertains to the type of evidence that the FDA may consider when determining a product’s intended use. According to the recent announcement, the delay will allow “further consideration of the substantive issues raised in the comments received regarding the amendments.”
The concept of intended use is two-fold: first, the intended use of a product is used to determine whether it can be considered a drug, device, or other FDA regulated product. Second, it acknowledges the potential existence of off-label use and promotion.
In 2015, the FDA proposed changes to the intended use regulation. The “knowledge” sentence, as it was famously named, was causing confusion among industry groups and required clarification.
The original statement: “But if a manufacturer knows, or has knowledge of facts that would give him notice, that a [drug or device] introduced into interstate commerce . . . is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling for such a drug/device which accords with such other uses to which the article is to be put.”
In January 2017, the rule was finalized. Most people expected the controversial “knowledge” sentence to be removed entirely, but instead, it was simply amended with a new “totality of evidence” standard added.
The updated statement: “And if the totality of the evidence establishes that a manufacturer objectively intends that a device [or drug] introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than ones for which it has been approved, cleared, granted marketing authorization, or is exempt from premarket notification requirements (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 device from the requirements of section 502(f)(1), to provide for such device [or drug] adequate labeling that accords with such other intended uses.”
The language in this statement has proved to be concerning for many industry leaders who worry that knowledge of unapproved uses may be considered evidence of intended use.
After requesting comments from the public, the FDA decided to push the effective date for the proposed rule from March 2017 to March 2018, in order to fully evaluate the questions and concerns of industry. However, as of March 19, 2018, only the portion of the rule related to the regulation of tobacco products is in effect, with the intended use aspects delayed until further notice.
It is unclear when the FDA will be moving forward with a version of the intended use rule. However, it is clear that the Agency will be taking the time necessary to fully consider the public comments it received over the last few months. In a January 12, 2018, press release, the FDA wrote: “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.”
It will be very interesting to see what the future holds for this regulation, and we will keep you posted as any updates become available.
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