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Regulatory Focus™ > News Articles > FDA Delays Final Rule on Intended Uses

FDA Delays Final Rule on Intended Uses

Posted 17 March 2017 | By Michael Mezher 

FDA Delays Final Rule on Intended Uses

The US Food and Drug Administration (FDA) on Friday announced it will delay implementation of its final rule clarifying when tobacco products are regulated as medical products until March 2018 in response to a petition from biopharmaceutical industry groups that raised questions about how the rule would alter the agency's definition of intended uses for drugs and medical devices.

The petition, filed by on behalf the Medical Information Working Group (MIWG), the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Organization (BIO) by prominent law firms Sidley Austin LLP and Ropes & Grey, calls on FDA to stay the final rule and revert back to language found in the proposed rule.

According to the petition, FDA made significant changes to the final rule by introducing the concept of "totality of evidence" to the agency's definition of intended use without giving stakeholders the opportunity to comment.

Now, FDA says it will hold off on implementing the final rule for a year in order to gather feedback.


In September 2015, FDA published a proposed rule clarifying when tobacco products are regulated as drugs, devices or combination products.

While on its face, the rule pertained to classifying tobacco products, it also proposed to amend FDA's definition of intended use found in 21 CFR Sections 201.128 and 801.4 by deleting a clause that had long troubled industry.

Under the clause, FDA is not only able to regulate products based on their intended uses, but on their actual uses based on whether 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."

While FDA rarely enforced this "knowledge" clause, industry has remained concerned that the provision could lead to the agency requiring new marketing applications based on a company's knowledge of a product's off-label use.

However, in the final rule released last January, FDA amended the knowledge clause to read:

"And 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, 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 FDA, the change in language was made to reflect that the agency did not intend to completely eliminate manufacturer knowledge of off-label use as a source of evidence.

"FDA's clarification of its position and proposed deletion of the last sentence of these regulations in the proposed rule did not suggest that FDA sought to otherwise narrow the scope of evidence of intended use that FDA may consider. However, some of the comments misunderstood the proposal. For example, some comments asserted—incorrectly—that FDA intended to eliminate manufacturer knowledge altogether as a source of evidence of intended use," FDA said in January.

Public Comment

Now, FDA says it will give stakeholders 60 days to comment on the final rule.

"We are interested in comments on the petitioners' views on the proper interpretation of 'intended use.' FDA solicits comment on the appropriateness of the various limitations suggested by petitioners, including limiting the evidence that may be considered to establish a product's intended use to the manufacturer's or distributor's promotional statements; requiring that a manufacturer make an explicit promotional claim before FDA may find a new intended use; and allowing an exception for relying on circumstantial evidence 'only when its probative value is sufficient to negate any explanation other than the intended use of the product as a drug or device,'" FDA writes.

With those issues in mind, FDA asks for input on how it should proceed with the final rule, and for comment on potential public health or First Amendment issues related to its interpretation of intended use.

Federal Register, Petition


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