FDA-mandated REMS now in force in pharmaceutical industry

Key Points

So what is a REMS? It is an FDA risk-management plan that applies only to prescription drugs and biologicals, and requires use of tools beyond the routine labeling and dispensing of prescriptions. The effect of REMS ripples down the supply chain to affect how pharmacies dispense medication, even though the FDA has no regulatory authority beyond manufacturers. However, if a manufacturer does not comply with REMS requirements, the FDA can: (1) prohibit the drug from being introduced into the market, (2) find the drug to be misbranded, and (3) impose civil penalties.

The FDA has authority to require a REMS either during the pre-approval phase of a given drug or biological, or post-approval after it has already been in the marketplace. Pre-approval REMS occurs before the drug or biological enters the marketplace, if the FDA determines that a REMS is necessary to ensure that the benefits of the drug outweigh its risks to patients. Post-approval occurs if FDA becomes aware of new safety information and deems that a REMS is necessary.

With respect to ETASUs, a REMS may require that prescribers and dispensers of the drug or biological have certain training, experience, or certification. They may further require the drug or biological only be dispensed in certain healthcare settings, that the drug be dispensed to patients with evidence of safe use, that a patient using the given drug or biological be subject to monitoring, or that a patient using the drug or biological be enrolled in a registry. The FDA could even require an implementation system if certain ETASUs are present.

On Feb. 6, the FDA informed manufacturers that a REMS will be required for certain opioid drug products. The FDA held a series of meetings with stakeholders and solicited public comments to help with the development of opioid REMS. Most recently, a buccal soluble fentanyl drug was approved by FDA with a REMS requirement. As part of the REMS, the drug may be obtained only through FOCUS, a restricted distribution program. Only those prescribers, pharmacies, and patients registered with FOCUS will be able to prescribe, dispense, and receive it. Training and educational programming will be provided to prescribers and pharmacists. Patients receiving the medication will be subject to a counseling call before the drug is dispensed.

Through regulation of manufacturers, a REMS might affect prescribers and pharmacists at the level of professional practice. One question that arises is whether Congress and the FDA are exceeding their authority by indirectly regulating professions that traditionally have been governed by the various states.

Ned Milenkovich is a member at McDonald Hopkins, LLC, where he chairs the Drug & Pharmacy Practice. He is a member of the Illinois State Board of Pharmacy. E-mail him at nmilenkovich@mcdonaldhopkins.com or call 312-642-1480.