Ensuring the Safety of Medications: Key Pharmacy Implications of the FDA Amendments Act of 2007

Program Description

The authority of the U.S. Food and Drug Administration (FDA) to ensure drug safety was strengthened when Congress approved the Food and Drug Administration Amendments Act (FDAAA) of 2007. Under this law, FDA has the authority to require studies and clinical trials to explore possible serious risks associated with a drug for a pending or approved application. Further, FDA also will increase the drug safety information, adverse drug event (ADE) data, and health record and claims data it collects.

One new aspect of FDAAA of particular importance to pharmacists is the requirement that a new or abbreviated drug application or an application for a biological product include a risk evaluation and mitigation strategy (REMS). FDA can also require a manufacturer to submit a REMS after a drug is approved if new safety information becomes available suggesting that risk evaluation and mitigation are warranted. The law further requires that a REMS be assessed 18 months, 3 years, and 7 years after approval. Pharmacists must be aware of the existence and specific requirements of approved REMS programs to ensure that they are appropriately implemented and have the intended effect of improved patient safety.

Also important to pharmacists is FDA’s plan to address the lack of standardization among restricted drug distribution systems (RDDSs). Proposed changes should address pharmacists’ concerns about the difficulties in obtaining drugs covered by RDDSs. The new law requires that RDDSs not be burdensome to the health care system or to patients and requires FDA to post a notice within 30 days of requiring restriction of a drug’s use explaining how the restriction will mitigate the drug’s risk.

This symposium will provide an in-depth review of these new policies to ensure that patient access to needed medications is not impeded and that these measures meet their intended goal of ensuring safety in the use of medications. Faculty will engage the audience in discussion and solicit audience participation throughout the symposium.