- May 04, 2022
On 9 August 2021, FDA published a notice announcing its implementation of a court decision in Genus Medical Technologies LLV v. FDA (Genus) and requesting public comment. The notice states that in accordance with the Genus decision, FDA “intends to regulate products that meet both the device and drug [emphasis original] definition as devices, except where the statute indicates that Congress intended a different classification, and we further intend to bring previously classified products into line with the Genus decision. Accordingly, FDA will examine product classifications, paying particular attention to those products that have been regulated as drugs even though they may satisfy the device definition.”
The US District Court for the District of Columbia ruled that the Genus Medical Technologies radiopaque contrast agent Vanilla SilQ, which people drink before undergoing computed tomography or radiography, is a device and not a drug. The court said that FDA “does not have discretion to regulate all contrast agents uniformly,” differentiated Vanilla SilQ from other contrast agents: because “Vanilla SilQ products, unlike other contrast agents, do not chemically interact with the body, they should be regulated as devices.” (RELATED: Court Rules Against FDA’s Finding That a Device was a Drug Regulatory Focus, 9 December 2019).
FDA received 37 comments on the notice by the public comment deadline of 30 November.
Implementation not ‘legally viable’
The Association for Accessible Medicines (AAM) objected to the notice, saying that FDA’s reading and implementation of the court order is not “legally viable.” The group said FDA “has no legal authority for reclassifying products that its longstanding regulations require the Agency to regulate as drugs. Nothing in the Genus decision dictated withdrawal of regulations, let alone reclassification of products that otherwise have been classified through duly promulgated regulations without such withdrawal.”
GE Healthcare (GEHC) concurred. “The D.C. Circuit’s decision in Genus was not a determination that the product at issue (barium sulfate), or any other specific product, was a ‘device.” As noted by the Genus Court, its decision was ‘purely a legal one’ holding that FDA may not rely solely upon its discretion to regulate a product as a ‘drug,’ if that product meets the statutory definition of a ‘device.” In so holding, the Genus Court reaffirmed the existing statutory definitions of ‘drug’ and ‘device’ and called upon FDA to apply such definitions when determining the appropriate regulatory pathway for a product.”
Imaging agents should continue to be regulated as drugs
The comments urged FDA to continue regulating imaging agents as drugs. GE Healthcare “believes that FDA has always made the correct decision – both legally and scientifically – to regulate imaging agents as drugs and should continue to do so.
The law firm of Arnold and Porter concurred. “We request that in implementing Genus, FDA ensure that imaging agents that meet the definition of a drug, but not a device, will continue to be regulated as drugs under the new drug application (‘NDA’) and abbreviated new drug application (‘ANDA’) pathways,” wrote the firm. “Significantly, we believe there are imaging agents that, even when analyzed pursuant to the decision in Genus, remain appropriately regulated as drugs under the Federal Food, Drug, and Cosmetic Act (FDCA’), rather than as medical devices.”
Eye cups, eye droppers now devices
AAM asserts that the Agency has already started to implement the court order. In a recent FDA communication, the Agency has determined that eye cups, eye droppers, and ophthalmic dispensers that are regulated as drugs when packaged with other drugs are “now obsolete” and meet the definition of a device, said AAM.
AAM said some of its member companies have begun receiving notices of deficiencies and even complete response letters from FDA that indicate the Agency “is implementing a new regulatory structure for these products without any process whatsoever.” The group says that “the abrupt manner in which FDA effectuated this change would be troubling enough even if FDA’s position were legally viable. It is not.”
GE and Advamed: Considerable amount of time
Both GE and the Advanced Medical Technology Association (AdvaMed) pointed out that another factor to consider is the considerable amount of time and expense involved in transitioning imaging agents from the drug quality management system to the device system.
GE said that it will take a “considerable amount of time for the applicant to transition the product with regard to labeling, bringing the applicable manufacturing facilities into compliance with the QSR, and preparing for a device inspection, among other things. GEHC agrees and notes that the speed at which labeling can be updated will not be in an applicant’s control, as presumably, it will require FDA review. Given the complexity of the transition, GEHC believes that applicants will need at least 18 months to come into compliance with the FDA’s QSR (Quality System Regulation), and to ensure that their facilities are ready for inspection — after the final decision to reclassify a product has been made. GEHC also believes that it will take at least 18 months after FDA sanctions new labeling for a given product, for the applicant to ensure that product labeling is updated.”
AdvaMed made a similar observation, saying that several elements of current GMP for pharmaceuticals, such as testing and approval or rejection of components, drug product containers, closures, calculation of yield, expiration dating, release testing for distribution, stability testing, do not exist for medical devices.The group urged FDA to grandfather in existing products and allow phased-in implementation to allow these products to be complaint with FDA’s QSR for medical devices to avoid supply chain interruptions.
AdvaMed states that “the consideration for grandfathering may also help potential interruptions to the supply chain as active pharmaceutical ingredient (API) suppliers, companies that solely manufacture drugs, testing laboratories and/or distributors may not be willing to add elements of QSR. Therefore, this can significantly impact a company’s ability to develop and supply its products.”
GE added that reclassifying imaging agents from the drugs to devices category can compromise the safety of these products. The decision “has the potential to affect the substantial safety benefits that have been achieved through the required clinical trials, post-market studies, quality controls, collective data, and even the familiarity with imaging agents, developed over several decades of drug regulation. Thus, a fundamental question for FDA to consider is whether investing significant resources to review numerous imaging agents and potentially move them to device regulation will provide a countervailing public benefit and/or add risk to public safety.”
PhRMA says more time needed to implement classification
The Pharmaceutical Research and Manufacturers of America (PhRMA) pointed out that industry needs more time to implement this reclassification. The group further adds that “the time necessary for industry members to make this transition must span multiple years — akin to the 10-year transition period provided under the BPCIA [Biologics Price Competition and Innovation Act]. In that context, Congress prescribed a 10-year transition period in order to allow for sufficient time for FDA implementation without undue burden or disruption of patient access to the products involved. This process ensured that all parties affected by the transition were informed of FDA’s proposed approach and had the opportunity to engage with FDA over the course of the transition.”
PhRMA also urged FDA to take a step-wise approach to implementing this reclassification. The group added that “FDA, in implementing the Genus decision…needs to develop guiding principles to distinguish between articles that are device constituents of drug-device combination products and articles that are drug packaging or container closures and therefore, drugs.”
REFERENCE: RAPS, Regulatory Focus, News Articles (2021 12); 10 DEC 2021; Joanne S. Eglovitch