Guest Commentary: Minimizing Risk with REMS – Time to Measure Results

Mike Toscani, PharmD
Project Director
Jefferson School of Population Health

REMS (Risk Evaluation and Mitigation Strategies) is one of the latest initiatives used by the FDA to minimize risks associated with biopharmaceuticals (prescription drugs and biologic products).

Historically, many drug safety issues have led to changes in FDA policy. In 2007, the FDA enacted the REMS and post-marketing study (PMS) requirements that are now in place. This act took the use of RiskMaps to a higher and more enforceable level with sponsors to help ensure drug safety and ongoing pharmacovigilance.

Now, the FDA may require biopharmaceutical sponsors to develop a REMS program prior to marketing approval or may require one based on post-marketing safety information. For select products, a REMS program could include a patient medication guide, a patient package insert, or a targeted communication plan for healthcare providers that could involve educational programs, letters, and other initiatives to encourage the safe use of these medications.

If a more serious risk exists, the sponsor may be required to provide elements to assure safe use (ETASU), which might include: restricting the use of the product via distribution channels, specialized training, a certification program for healthcare providers, pharmacies, facilities, attestations to assure proper patient selection, active patient monitoring, and registry programs. In addition to REMS, the FDA may require the sponsor to conduct PMS trials following approval.

Currently, there are over 80 drugs and biologics with approved REMS programs. Most of these only require a medication guide, but some require a communication plan, while others require an additional ETASU implementation system. In addition to the incremental costs, there is concern that having REMS programs that are too cumbersome to initiate for providers and patients could lead to the use of other less effective products.

Data describing the ability of these programs to directly impact reducing risk has been lagging. There is a strong need to conduct ongoing outcome studies to evaluate the effectiveness of these programs at reducing risk and measuring the potential for under use of these products by healthcare providers for patients who could likely benefit from them.