Healthcare System Must Change to Improve Drug Safety, FDA Tells IOM

Improving overall drug safety is the responsibility of the entire healthcare system and not simply the FDA, top agency officials told a panel of medical experts who will recommend changes to the FDA's current oversight system for marketed drugs.

"You cannot look at the FDA in isolation," Janet Woodcock, the agency's acting deputy commissioner for operations, told members of the National Academies' Institute of Medicine (IOM). "It must be viewed in concert with all the other parties that are charged [with] and have some piece of ensuring drug safety in this country," she said at the first meeting of the IOM panel convened to address growing public concerns over drug safety. The IOM panel is scheduled to issue its drug-safety recommendations in July 2006.

Focusing simply on withdrawing drugs, for example, obscures the real problems with the system, Woodcock said. "To a large extent, drug safety is a function of the safety of the healthcare system," she said. Under the current system, adverse drug reactions account for up to 100,000 fatalities and a large number of hospitalizations annually.

Many drug risks are avoidable and related to use patterns, including prescribing habits and drug-drug interactions, Woodcock noted. Although the FDA evaluates the risks and benefits of a drug for the entire population, the keystone of drug safety is the prescriber, she said. A learned intermediary is charged with determining for an individual patient whether the benefits outweigh the risks — "that's a very different issue than for the population," Woodcock said, adding that patients also must be well-informed.

But Woodcock also acknowledged that no entity — government or otherwise — is charged with investigating and resolving long-term safety issues, particularly for chronically administered drugs.

The need for a national authority to evaluate long-term drug safety is one point the FDA wants the IOM to consider in its deliberations, according to Steven Galson, acting director for the FDA's Center for Drug Evaluation and Research. "Is the ad hoc system that currently exists in the U.S. adequate to do that, where the responsibility is shared over a lot of different agencies?" Galson asked the IOM panel.