Stakeholders Tell FDA to Revise or Pull Draft Guidance on Classifying Drugs, Devices

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By Bronwyn Mixter

In comments to the Food and Drug Administration, stakeholders said that a draft guidance on classifying products as drugs or devices would cause many products already on the market to be reclassified and urged the agency to either withdraw the draft guidance or revise it.

FDA in a June 21 Federal Register notice (76 Fed. Reg. 36133) solicited comments on Draft Guidance for Industry and FDA Staff: Classification of Products as Drugs and Devices and Additional Product Classification Issues. Comments on the draft guidance were due Sept. 19.

In its comments, the Washington Legal Foundation (WLF) urged FDA to withdraw the draft guidance, saying that it conflicts with the federal statute that defines what constitutes a medical device.

WLF said the draft guidance would cause numerous products previously classified as medical devices to be reclassified as drugs. Also, WLF argued that the draft guidance violates the Administrative Procedure Act (APA), because all major changes in FDA policy may only be undertaken under the APA's formal notice-and-comment rulemaking procedures, not with informal guidance documents.

“As the size of the administrative state grows, it is important that citizens continue to have a meaningful opportunity to participate in the operation of their government,” WLF Chief Counsel Richard Samp said in a press release. “The APA is an important part of that effort. It ensures that agencies will be bound not only by congressional laws but also by their own internal rules. FDA needs to cease its practice of ignoring APA requirements.”

The dividing line between a device and a drug can sometimes be difficult to discern, WLF said. In general, manufacturers would prefer to have their products classified as devices because that often makes it easier for the manufacturer to get marketing clearance from FDA, the foundation said.

WLF said that under federal law, the principal distinguishing feature between a device and a drug is set forth in 21 U.S.C. §321(h)(3). In that law, a medical product qualifies as a device only if it “does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and … is not dependent on being metabolized for the achievement of its primary intended purposes.” If it does achieve its “primary intended purposes” through chemical action, then it is classified as a drug, WLF said.

For the past 30 years, FDA's general understanding has been that a product will be classified as a device, even if one of its clinical effects involves a chemical action, if the predominant intended purposes of the product do not involve a chemical action, WLF said.

However, the draft guidance substantially alters the classification rules, WLF said. It provides that any intended clinical benefit of a product should be deemed a “primary intended purpose.” Thus, according to the draft guidance, a product should be classified as a drug if any of its clinical effects involves a chemical action, which would cause many devices to be reclassified as drugs, WLF said.

Industry Comments

The Advanced Medical Technology Association (AdvaMed) said it does not agree with the way the draft guidance defines drugs. “As reflected by the legislative history, products that achieve their primary intended purposes through a device (physical) mechanism will be regulated as devices, and not drugs,” AdvaMed said.

AdvaMed said it is concerned that the draft guidance could bring about reclassification and jurisdictional transfer of existing products. “Reclassification is not a desirable outcome for industry or the public health, and has the potential to create tremendous confusion,” AdvaMed said.

Direct evidence of public health concerns should drive changes in product jurisdiction and regulatory classification, not changes in the interpretation of statutory terminology, AdvaMed said. “We strongly suggest that FDA consider the impact on industry of reclassifying devices that already are on the market.”

AdvaMed said that many post-marketing responsibilities, such as good manufacturing practices and adverse event reporting, vary across FDA centers and product classifications. “The confusion, cost, and time involved in transitioning to a new product classification for these devices likely will be substantial,” the association said.

Also, AdvaMed said FDA should add information on combination products to the draft guidance.

In comments submitted Sept. 15, the Combination Products Coalition (CPC) said it is concerned that applying the draft guidance may prevent FDA's Office of Combination Products (OCP) from meeting its mandated mission of ensuring “the consistency and appropriateness of postmarket regulation of like products subject to the same statutory requirements.” CPC is a group of drug, biological product, and medical device manufacturers with interest in the combination products area.

CPC said the draft guidance may cause the same product or combination product to have two different classifications.

Also, CPC said FDA should issue similar draft guidance on the definitions of biological products and combination products.

Genentech Inc., a member of the Roche Group, said FDA should “articulate the principles of science and public health that support the agency's product classification determinations, and post this information on the OCP website.”

“Increased transparency as to reasoning behind classification determinations would enable product developers to conduct better product development resource planning and understand how similarly situated products will be classified,” Genentech said.

Genentech also said FDA should provide additional guidance on classification determinations for biologics and combination biologic/drug and biologic/medical device products.


The draft guidance is available at http://www.fda.gov/RegulatoryInformation/Guidances/ucm258946.htm .