By Ingfei Chen

Drug Safety Monitoring

By Ingfei Chen

In 2006, an Institute of Medicine assessment found major shortcomings in the efforts of the U.S. Food and Drug Administration (FDA) to ensure the safety of new pharmaceuticals. Since then, the FDA has implemented a host of reforms, including ones designed to enhance its surveillance of risks from medications after they’ve won the agency’s approval.

The FDA can now require that drug companies execute a plan, known as a Risk Evaluation and Mitigation Strategy, to manage serious side effects of certain medications. Such a plan might call for distributing a medication safety guide or verifying that prescribing doctors have specialized training.

Regulators can also require companies to conduct post-marketing research to address safety questions—commitments that previously were voluntary. The FDA is imposing the tougher conditions on an increasing number of cancer drug approvals, says Duke University oncologist Gary Lyman, who sits on the FDA’s oncology drugs advisory panel. By doing so, the agency has struck the best balance between speed of approval and drug safety, he says.

The FDA also intends to develop a national program that will draw on several vast electronic databases of patient information to actively track the use of medical products and help spot early signals of adverse drug reactions. The FDA’s MedWatch system is also being revamped to make it easier for consumers to report adverse events from drugs.