Genus Decision Continues to Ripple Through Industry

It’s not often that FDA issues an “Immediately in Effect Guidance,” but it’s not often that a case like Genus v. FDA comes along and upends twenty years of FDA practice.  Almost a year after the D.C. Circuit held that products that simultaneously meet both the FD&C Act’s general “drug” definition and its more-restrictive “device” definition must be classified and regulated as “devices,” FDA issued an “Immediately in Effect Guidance” to implement the decision as applied to ophthalmic products.  In the Guidance, entitled Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4, FDA explains that it can no longer regulate eye cups, eye droppers, and other dispensers intended for ophthalmic use as drugs when packaged with the ophthalmic drug with which they are intended to be used as a result of the Genus decision.  This is because the Genus decision no longer allows FDA to regulate devices as drugs, and, if the dispensers provided with the drug are devices, then the entire product as supplied must be considered a combination product.  Consequently, the Guidance announces that FDA will now “regulate these products as drug-led combination products composed of a drug constituent part that provides the primary mode of action and a device constituent part (an ophthalmic dispenser).

With the drug as the primary mode of action, the product will stay in the Center for Drug Evaluation and Research, but as a combination product, different requirements apply.  Manufacturing practices for combination drug-device products, as the relevant ophthalmic products will now be regulated, must consider both the cGMP requirements and QSRs, which may require additional steps or documentation.  Manufacturers may continue to use a cGMP-based operating system, but it must integrate each applicable provision of the device QSRs.

For the next 12 months, FDA will exercise enforcement discretion while impacted sponsors develop a Quality System that complies with 21 C.F.R. § 820.  Products subject to pending applications will be required to submit additional documentation for the combination product, including all facilities involved in the manufacturing of the device element.  Depending on the risk profile of the product, FDA may decide to evaluate new QS regulation requirements only during inspection following approval, may require a Pre-Approval Inspection, or may review quality information as part of the quality assessment of the combination product application.  However, “FDA anticipates that pre-approval assessment of [sponsor] compliance with any applicable QS regulation requirements generally will not need to include facility inspection against these requirements.”

As FDA attempts to implement Genus, industry should expect to see more products transitioning from drug to device and more guidances like this one to facilitate those transitions.  If you’re the sponsor of one of the products that Genus likely affects, be on the lookout for your own Immediately in Effect Guidance.