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FDA issues proposed rule clarifying stance on intended use

Posted 23 September 2020 | By Michael Mezher 

FDA issues proposed rule clarifying stance on intended use

After delaying implementation of parts of its final rule on intended uses multiple times, the US Food and Drug Administration (FDA) on Tuesday proposed a new rule clarifying its position on the types of evidence it will consider when determining a product’s intended use. The new rule would also repeal and replace the unimplemented portions of the earlier final rule.
The saga to update FDA’s intended use regulations began in 2015, when the agency first issued a proposed rule that was eventually revised and made final in January 2017, despite pushback from industry. However, before the rule took effect, FDA delayed its implementation by a month-and-a-half in February 2017, then by a year in March 2017, before delaying it indefinitely in March 2018.
RELATED: How an FDA proposed rule for tobacco products could have a big impact on 'intended uses' for devices, drugs, Regulatory Focus 19 October 2015; Industry groups petition FDA over revisions to ‘intended use’ rule, Regulatory Focus 16 February 2016; FDA delays final rule on intended uses, Regulatory Focus 17 March 2017;  FDA delays implementing parts of 'intended use' rule, Regulatory Focus 15 March 2018).
The delays were prompted by confusion and concerns raised by pharmaceutical and biotech industry groups, who petitioned the agency to stay the rule and revert to its original proposal to delete two rarely enforced clauses, found in 21 CFR 201.128 and 801.4, that allow FDA to regulate products according to their actual uses based on whether a manufacturer “knows, or has knowledge of” information that would indicate that a drug or device will be used for other uses outside the product’s specified intended use.
Instead of removing the clauses as it initially proposed, the 2017 final rule revised them to state that, “If the totality of the evidence establishes that 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 … to provide for such drug adequate labeling that accords with such other intended uses.” An equivalent revision, including the “totality of the evidence” language, was included for devices.
In the Federal Register notice for the new proposed rule, FDA explains that, “Some firms have expressed concern that the … sentence … could be read to mean that a firm’s mere knowledge of an unapproved use of its approved drug product automatically triggers requirements for new labeling that in turn renders distribution of that approved product unlawful without approval of a supplemental application.”
Now, FDA says it will delete the sentence altogether and insert a new sentence explaining that, “A firm would not be regarded as intending an unapproved new use for an [approved or cleared medical product] based solely on that firm’s knowledge that such [product] was being prescribed or used by health care providers for such use,” clarifying that the firm’s knowledge of an unapproved use would not, by itself, trigger new labeling obligations.
According to FDA Commissioner Hahn, the newly proposed revisions “do not reflect a change in the FDA’s policies and practices, but rather seek to clarify the regulatory language describing the types of evidence we consider relevant to determining a product’s intended uses.”
Hahn further explained that the agency’s longstanding position is to consider any relevant source of evidence in evaluating a product’s intended use.
The proposed rule also provides examples of the types of evidence FDA believes are relevant to establishing intended use, including express claims and representations, implied claims, product characteristics and designs and the circumstances of the sale or distribution.
The agency also provides some counterexamples, that, “Standing alone, are not determinative of intended use.” These include, “Knowledge, alone or in the context of ‘safe harbors,’ of health care providers prescribing or using an approved product for an unapproved use,” and several specific examples including hypothetical social media activities, internal sales projections and US Securities and Exchange Commission filings that would not on their own trigger a new labeling requirement.
FDA, Federal Register Notice


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