Institute of Medicine Releases Report on Studying the Safety of Approved Drugs

At the request of FDA, the Institute of Medicine (IOM) prepared a report containing recommendations for how the agency might better monitor the safety of drugs after they have been approved. The report, titled Ethical and Scientific Issues in Studying the Safety of Approved Drugs, recommends a life-cycle approach to safety monitoring. In such an approach, processes are in place to collect, assess, and act on data about a medication's benefit-risk profile from approval until it is no longer marketed.

One of the report’s key recommendations is that FDA should create a benefit and risk assessment and management plan for each drug in the form of a single, comprehensive, publicly available document. This document would serve as a central repository of information for each product from its approval throughout its entire time on the market. The report also recommended enhanced surveillance for certain categories of higher-risk drugs, such as first-in-class molecules, drugs approved through the use of several surrogate endpoints that provide conflicting evidence about likely health outcomes associated with the drug, or drugs that have a strong biological rationale for a particular side effect.

"We believe that the adoption of a life-cycle approach to drug approval and monitoring will help the agency strengthen its oversight, better tackle these complex decisions, and increase public confidence in the agency's ability to protect public health," said Steven N. Goodman, professor of medicine, health research, and policy, and associate dean for clinical and translational research at Stanford University School of Medicine, in an accompanying press release. "This will become increasingly important as FDA looks for ways to safely expedite the drug approval process."

FDA notes that many of the recommendations in the report are in step with ongoing agency programs and processes. In a statement issued by the Center for Drug Evaluation and Research the agency notes, “FDA monitors a drug’s safety throughout its lifecycle, and considers the oversight of drugs once they reach the market of equal importance to the premarket review of new drug and biologics applications.” FDA also says that while the creation of a central, publicly-accessible risk management plan for each drug is a good recommendation, they are too resource constrained at this time to implement such a program. The agency says it is in the process of fully analyzing the report to determine how to implement changes that will have the largest positive impact on public health.