AdvaMed Raises Questions With FDA’s Combo Product Proposed Rule

Regulatory NewsRegulatory News | 16 July 2018 |  By 

AdvaMed is taking issue with the US Food and Drug Administration’s product jurisdiction proposed rule, which the device group thinks strays from how the 21st Century Cures Act defined combination products, according to comments released Monday.

Some of the proposed revisions run counter to the plain language and intent of Section 3038 of the Cures Act, AdvaMed said. The group is seeking to clarify that a combination product’s primary mode of action shall not be determined to be that of a drug or biologic solely because the product features “any chemical action” in or on the body.

“Given the importance of this principle to addressing the problem that Congress identified with FDA’s drug-centric classification approach, FDA should affirm in its rulemaking the proposition that it will not make a drug or biologic classification based on any chemical action,” AdvaMed said.

The rule in question defines primary mode of action as “the single mode of action of a combination product that provides the most important therapeutic action of the combination product. The most important therapeutic action is the mode of action expected to make the greatest contribution to the overall intended therapeutic effects of the combination product.”

But AdvaMed claims that this definition “seems to overlook the Cures Act’s addition of section 503(g)(1)(E) to the Federal Food, Drug, and Cosmetic Act. This provision prohibits FDA from determining that ‘the primary mode of action is that of a drug or biological product solely because the combination product has any chemical action within or on the human body.’”

AdvaMed also notes congressional “concern that the presence of even minimal chemical action often leads FDA to conclude that a product’s primary mode of action is that of a drug or biologic, rather than a device.”

The Combination Products Coalition also requested that FDA ensure that a mechanism is included in the request for designation process “to ensure that all evidence is fully considered and that appeal processes remain available.”

Meanwhile, Steven Ferguson, chairman of the board of Cook Group, wrote that the proposed rule creates confusion with its use of “classification,” particularly with respect to the role of product jurisdiction officers. He also sought clarity on the scope of the rulemaking and the appeals process for product classifications and assignments.



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