FDA Seeks Comments on Transition of Certain Drugs to Device Status Following Genus DC Circuit Decision

Introduction

Whether a medical product is classified as a “drug” or “device” has significant regulatory implications, particularly for products that appear to meet the definitions for both “drug” and “device” under the Federal Food, Drug, and Cosmetic Act (FDCA).¹ This question, and FDA’s discretion to determine a product’s regulatory classification, was at the heart of the DC Circuit’s April 2021 decision in Genus Med. Techs., LLC v. FDA.²

In Genus, the DC Circuit determined that FDA does not have the discretion to regulate as drugs products meeting the definition of both “drug” and “device” under the FDCA, and must instead classify such products as devices in most scenarios. The decision will have significant implications for certain medical products, as its implementation is expected to require such products to transition from “drug status” to “device status.” On August 9, 2021, FDA published a Federal Register notice announcing implementation of the DC Circuit’s decision and further soliciting “public comment to inform the Agency’s deliberations about products potentially impacted by the Genus decision and the way in which impacted products should be transitioned from drug to device status.”³

Background

Under the FDCA, whether a product is regulated as a drug or device turns on the intended use of the product. In relevant part, the FDCA defines “drugs” to include “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.”⁴ The FDCA defines the term “device” to include “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is . . . intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, . . . and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.”⁵

For nearly 25 years, since a 1997 court decision in Bracco Diagnostics, Inc. v. Shalala,⁶ FDA has regulated certain products meeting the statutory definitions of both “drugs” and “devices” as drugs. One such category of products is contrast imaging agents. Imaging agents, such as contrast imaging agents, are sometimes used in conjunction with imaging devices (e.g., MRI, CT) to improve visualization of various parts of the body in radiographic diagnostics. In certain other types of imaging, such as radiopharmaceutical imaging, “the device alone cannot produce a usable image, and it is necessary to administer an imaging agent to the patient before using the imaging device.”⁷ In the Bracco case, which, like Genus, addressed a challenge to FDA’s regulatory designation of contrast imaging agents, the court explained that FDA had discretion in its classification of the relevant products—which the court noted “likely meet both the [FDCA] definition of a drug and the definition of a device”—but that the Agency was not free to “treat [the products] dissimilarly and to permit two sets of similar products to run down two separate tracks, one more treacherous than the other, for no apparent reason.”⁸ Since the 1997 case, FDA has consistently regulated contrast imaging agents as drugs to allow the Agency “to regulate them consistently under the same authority in the Center for Drug Evaluation and Research (CDER).”⁹

In Genus, however, the DC Circuit held that the FDCA does not grant FDA the discretion to classify as a “drug” any product that meets the statutory definition of a “device,” and that, excepting combination products, “devices must be regulated as devices[,] and drugs—if they do not also satisfy the device definition—must be regulated as drugs.”¹⁰ The DC Circuit explained that “the FDCA's definition of a ‘device’ is drawn more narrowly than its definition of a ‘drug’” and that to the “extent the drug and device definitions conflict, it is the narrower definition—the device definition—to which we must give effect.”¹¹ Notably, however, the DC Circuit provided that the Agency maintains wide latitude in determining a product’s regulatory classification and explained that the Court “do[es] nothing to restrict the agency's discretion to determine, in close cases, whether a particular product satisfies the device definition.”¹²

FDA Actions

FDA’s notice explains that the government will not appeal the DC Circuit’s Genus decision, and that the Agency in the future “intends to regulate products that meet both the device and drug definition as devices, except where the statute indicates that Congress intended a different classification” and that the Agency “intend[s] to bring previously classified products into line with the Genus decision.”¹³ FDA explained that it “intends to establish a process for the orderly and efficient determination of which products currently regulated as drugs must be regulated as devices[.]”¹⁴ The Agency noted that in cases where products must be reclassified, and in future classification determinations, it expects that “the determining factor in many cases to be whether the product achieves its primary intended purposes through chemical action within or on the body or is dependent upon being metabolized for the achievement of its primary intended purposes” despite the fact that FDA traditionally has “not always examined these factors in determining how to regulate certain types of medical products[.]”¹⁵ With respect to imaging agents specifically, FDA explained that it “intend[s] to reexamine whether individual imaging agents meet the device definition.”¹⁶ FDA also “intend[s] to reexamine other product categories as well, as appropriate.”¹⁷

FDA invites public comment through October 8, 2021 on “categories of products currently regulated as drugs that may be required to transition to device status under Genus” as well as “statutory provisions other than the drug and device definitions that may indicate Congressional intention regarding the appropriate regulatory pathway . . . for certain types of products.”¹⁸ The Agency noted that it plans to publish a future notice of products that it tentatively determines should be transitioned, and that the public will have an opportunity to comment on this tentative list before its finalization. FDA also invites public comment on the timelines that stakeholders may need for potential product classification transitions. Finally, FDA explained that it does not expect the reclassification process to be completed before October 1, 2021. Therefore, the Agency recommends that entities assessed FY 2022 user fees should pay such fees and seek reimbursement for any products which are subsequently transitioned.

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These developments will have significant implications for medical products that meet the statutory definition of both “drug” and “device,” and may have further implications for other FDA classification standards and guidances. Manufacturers of medical products should carefully evaluate whether their existing products may be subject to a regulatory classification transition, and consider how pipeline products may be classified by FDA. Manufacturers may also want to begin to consider and plan for the potential implications of transitioning previously approved drugs to device status, such as the potential need to update labeling, bring facilities into compliance with device quality system regulations, transition to compliance with device post-market safety reporting requirements, prepare for device inspections, and come into compliance with other statutory and regulatory device requirements. Additionally, stakeholders should analyze the potential coverage and reimbursement implications related to transitioned products. We encourage manufacturers to closely follow future FDA notices and related developments in this area.

© Arnold & Porter Kaye Scholer LLP 2021 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.