The FDA recently published its Final Guidance on REMS programs for prescription drugs, which we thought might interest our readers. The document is formally called “Format and Content of a REMS Document: Guidance for Industry” and you can download and review the Final Guidance here. You might be thinking two things at this moment: What is a REMS, and why do I care?
REMS stands for Risk Evaluation and Mitigation Strategy, and it refers to a risk management strategy that the FDA can require to ensure that the benefits of certain drugs outweigh their risks. As we have harped on for the life of the blog, all prescription drugs have risks and benefits. In the product liability world, those risks and benefits are managed most often by disclosing known and reasonably knowable risks to physicians so they can weigh those risks, and benefits, when treating their patients.
For some medications, the FDA can determine that a more structured strategy is required, which is where a REMS comes in. For certain drugs with serious safety concerns, the FDA can require additional requirements to support the safe use of that product. A REMS might require the drug manufacturer to develop materials for distribution to patients or pharmacists, or it might require additional communications to healthcare provides about particular safety concerns. It might require additional training or certification for prescribers or dispensers, or even require specific clinical interventions, such as specialized consent or specific patient monitoring. Or it might require some combination of all of the above, or more.
The point is that a REMS can take many forms, but the overall goal is safety. The new Guidance is intended to ensure that REMS documents are clear, understandable, and presented in a standardized format (consistent with the FDA’s Structured Product Labeling or SPL format). The Guidance also provides updated recommendations for the format and content of a REMS document for a prescription drug, including biologics. Like every other FDA guidance, the Guidance itself is nonbinding and does not carry the force of law. An FDA-adopted REMS, however, is a formal FDA requirement, comparable in the law to FDA-required product labeling.
So why do we care? We care because we care about product safety. But as product liability litigators, we care because a REMS can impact the potential liability for a prescription drug manufacturer in at least two ways.
First, prescription drug product liability cases almost always question the adequacy of the drug’s warnings. While every prescription drug has FDA-required labeling, a REMS can sometimes require additional warnings on a particular risk, which adds another layer of information for prescribers and additional protection for the manufacturer. The best example we could find was a case we blogged on a few years ago, Nelson v. Biogen Idec, No. 12-7317, 2018 WL 1960441 (D.N.J. Apr. 25, 2018). The prescription drug in Nelson had a REMS requiring that each patient acknowledge receipt of a medication guide before receiving the product. The risk information in the patient-acknowledged medication guide was part of a robust set of warnings provided on the exact risk that allegedly befell the plaintiff, which led to summary judgment for the manufacturer on the plaintiff’s failure-to-warn claim.
Second, as we have already noted, the REMS Guidance document is not binding law, but an FDA-adopted REMS is a requirement in federal law. As a result, any state law requirements—such as additional warnings compelled by a state-law product liability lawsuit—that conflict with a REMS should be preempted. This is something to keep an eye on. REMS are expressly intended to address safety in light of particular risks; they are developed specifically for particular drugs or types of drugs (they are generally “bespoke,” as our British colleagues would say); and they impose particular restrictions and limitations on prescription and use of those drugs. To the extent a state requirement conflicts with a REMS, preemption ought to apply.
We have not searched for preemption cases involving REMS, but we bet they are out there. If any useful cases come down the pike, we will let you know.