Shoring up the drug safety system

The Food and Drug Administration offers a new vision for safeguarding the nation's pharmaceutical products to protect the public health.

Editorial. Feb. 26, 2007.

Postmarketing surveillance. Risk communication. Safety profile reviews.

Such are the new buzzwords in a proposal unveiled Jan. 30 by the Food and Drug Administration to ensure that the nation's safety system for medicines and medical devices is the best it can be.

This FDA vision is worthy of attention. It is both timely and well-considered.

The initiative began in 2006, when the Institute of Medicine issued a report, "The Future of Drug Safety: Promoting and Protecting the Health of the Public." The document was commissioned by the FDA after the agency's reputation as a drug safety watchdog was clouded by adverse events and related incidents such as the market withdrawal of the painkiller Vioxx (rofecoxib) and the discovery of possible links between adolescent suicide and certain antidepressants.

Now the FDA's new report, a response to the IOM recommendations, represents an important step -- albeit an early one -- in a process that is critical to protecting patients and the public health.

Many of the FDA's proposals track closely with the IOM's recommendations. They also are consistent with policies of the American Medical Association. How the FDA's efforts continue to take shape from this point, however, is of great importance to physicians and their ability to practice medicine.

Upon the release of the proposal, the AMA commended the FDA. The AMA supports the agency's interest in stepped-up, post-marketing surveillance.

The AMA particularly noted the FDA's emphasis on strengthening the science that supports the nation's drug safety system. It also acknowledged the shared view that improving drug safety should not come at the expense of stifling innovation.