Reclassification of Ophthalmic Drugs: Are the Rules Evolving?
Top Food and Drug Regulatory Cases
By: Cheryl L. Rowe-Rendleman, PhD
The US Food and Drug Administration (FDA) adheres to the Federal Food Drug & Cosmetics (FD&C) act to decide whether a product should be regulated as a drug or device. There have been variances in a few cases and sponsors in turn have accepted the FDA interpretations and the differing regulatory strategies for these products. A recent court case, Genus Medical Technologies vs FDA has challenged FDA conventions. As a result, FDA will investigate and reclassify some drugs as devices. The implications to ophthalmology are discussed in this 3-part series.
In a 2019 court case Genus Medical Technologies (St Louis, MO) sued the FDA, because the agency classified its barium sulfate oral contrast agent (Vanilla SiLQ) as a “drug” and not a device.1,2 This classification was consistent with FDA regulatory policy since 1997 in which it was decided that all medical contrast agents were to be regulated as drugs.3, 4 The 2004 guidance to industry states that “medical imaging products generally are governed by the same regulations as other drug and biological products”.4 This was done so that the Agency could regulate all contrast agents consistently under a single authority in the Center for Drug Evaluation and Research.
Source: https://www.federalregister.gov/documents/2021/08/09/2021-16944/genus-medical-technologies-llc-versus-food-and-drug-administration.
According to Section 201 (h) of the FD&C Act (21 USC 321 (h)), the definitions of drugs and devices have considerable overlap except when it comes to the primary intended purpose. Devices are not dependent on metabolism or chemical action within or on the body in the achievement of their primary intended purpose.5 Upon reading the narrower definition of a device, the U.S. District Court and the US Court of Appeals for the District of Columbia rejected the position from FDA that the Genus contrast agent should be regulated as a drug despite previous regulatory precedent. It stated that the FDA could not choose-based on regulatory convenience or any other unenumerated consideration -whether to regulate any particular medical device as a drug.
(1) is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, and
(2) 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, or
(3) is intended to affect the structure or any function of the body of man or other animals, and
does not achieve its primary intended purposes through chemical action within or on the body, and is not dependent upon being metabolized for the achievement of its primary intended purposes.
Source: Classification of products as drugs and devices & additional product classification issues: Guidance for industry and FDA Staff. Final guidance (2017). US Department of Health and Human Services
The specific ruling against the FDA in the Genus litigation stated 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.” This seemingly obvious pronouncement is a “win” for manufacturers seeking device status for new products—as it is much less expensive to develop a device than a drug.
As a result of the ruling the FDA reported in the August 9, 2021, Federal Register (the daily journal of the United States government) that going forward it would regulate products that meet both the drug and device definitions as devices, except where the statute indicates that Congress intended a different classification. In a second statement FDA stated that it intends to comply with the ruling by re- examining the classification of other products that had been previously regulated as drugs to bring them into line with the Genus decision.
The implication of this second statement by the FDA will ripple throughout many other medical sectors including ophthalmology. According to a January 11 article in Bloomberg law; “the FDA has already told some eye drop manufacturers that their applications are “deficient or will not continue to move forward with review and approval without information on how they will comply with device regulations”.6
- Complaint, Genus Medical Technologies, LLC v. U.S. Food and Drug Administration, No. 19-544 (D.D.C. Feb. 28, 2019).
- Docket No. FDA-2021-N-0843 for “Genus Medical Technologies LLC v. Food and Drug Administration; Request for Information and Comments.
- Bracco Diagnostics, Inc. v. Shalala, 963 F. Supp. 20 (D.D.C. 1997), accessed at https://law.justia.com/cases/federal/district-courts/FSupp/963/20/1645246 on January 17, 2022.
- Developing medical imaging drug and biological products. Part 1: conducting safety assessments. Guidance for Industry, (2004). US Department of Health and Human Services. accessed at https://www.fda.gov/media/72295/download on January 18, 2022.
- Classification of products as drugs and devices & additional product classification issues: Guidance for industry and FDA Staff. Final guidance (2017). US Department of Health and Human Services. accessed on January 18, 2022.
- Castrunuova C. Drug or Device? Manufacturers see burden in FDA reclassifying. Bloom berg Law. Eds Alex Kramer, accessed at https://news.bloomberglaw.com/health-law-and-business/drug-or-device-manufacturers-see-burden-in-fda-reclassifying on January 18, 2022.
Author: Cheryl L. Rowe-Rendleman, PhD is a clinical development expert and founder of Omar Consulting Group, LLC
Omar Consulting Group, LLC helps drug developers and investigators create successful clinical and regulatory strategies that will be adequate for regulatory authorities.