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.

Posted Feb. 26, 2007.

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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.

Overall, the FDA initiatives include plans to develop new approaches to detect, understand, predict and prevent adverse events; create and incorporate new quantitative tools in benefit and risk assessment; and conduct a pilot program to review regularly the safety profiles of certain newly approved drugs.

The agency's blueprint also will seek to improve its internal operations and management as well as improve risk communication and information flow to physicians, other health professionals and patients.

This latter aspect of the FDA outline is high on the AMA's priority list. After all, the means by which information about the risks associated with drug products is communicated need an upgrade. The AMA has a natural interest in this area and will continue its collaboration with the FDA and other stakeholders to refine the way patients and physicians receive these sometimes life-or-death messages.

An important reminder, though, is that the best answer is not to move toward restricting the distribution of pharmaceuticals by creating layers of burdensome paperwork for doctors who need to prescribe certain medications. Instead, the FDA should work with the AMA and others throughout medicine and the pharmaceutical industry to find novel ways and improved strategies for risk communication.

As mentioned, the FDA's January response is an important advance in the effort to shore up the drug safety system. But it is not the only venue for action. Lawmakers in Congress also have turned their attention to the matter and, in the months ahead, their focus will likely increase. Expect the AMA to watch these developments closely as they continue to take shape.

Providing the best possible treatments for patients and ensuring drug safety are both extremely high and intertwined priorities. The plan's buzzwords reflect important reforms that are central to reaching these goals. The AMA has rightly cautioned that the methods to achieve those objectives should enhance, not limit, physicians' ability to help patients by practicing the best medicine.

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External links

Food and Drug Administration on drug safety, including the report, "The Future of Drug Safety," January (link)

"The Future of Drug Safety: Promoting and Protecting the Health of the Public," report highlights, Institute of Medicine, September 2006 (link)

"Enhanced Physician Access to FDA Data," AMA's Council on Scientific Affairs, June 2005 (link)

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