It's Been a Year. How Safe Are Your Drugs Now?

A scathing report on the Food and Drug Administration has created scarcely a ripple, says an expert commentator.


Those with any interest in the safety of prescription drugs—presumably that would be everyone—should take the time to read an angry editorial by Sheila Weiss Smith in the just published issue of the New England Journal of Medicine. It's available online for free, and the title says it all: "Sidelining Safety—The FDA's Inadequate Response to the IOM."

The FDA, of course, is the Food and Drug Administration. The IOM is the Institute of Medicine, an arm of the National Academy of Sciences that advises the nation on medical matters. It was the IOM that brought medical errors into the public arena in 1999 with "To Err Is Human."

The title of Smith's editorial refers to a different IOM report, "The Future of Drug Safety," released in September 2006. It found plenty of blame to go around for drugs that come to market with an uncertain safety pedigree—the pain reliever Vioxx is a recent example—or get too little scrutiny after reaching pharmacy shelves. Congress got slammed for underfunding the FDA.

But the report also clobbered the FDA itself. Its myopic view of safety, said the IOM, is built into the very bones of the agency. The way the FDA is organized internally is largely determined by its culture, and its culture devalues safety. Experts in drug safety within the agency, to take one example, may (or may not) be consulted by those who render the actual thumbs-up or thumbs-down decisions on new drug approvals, but the safety experts have no authority themselves.

OK, says Smith. It's been a year since the report appeared, followed by the inevitable round of congressional hearings, followed by—what? "Sadly," she writes, "the FDA's official response falls far short of what the American public expects and deserves." For a medical journal, the language of Smith's editorial is strong, but that may not be surprising given her background. She has served on various FDA advisory committees and is on the faculty of the Center on Drugs and Public Policy at the University of Maryland School of Pharmacy. She was also a consultant to the IOM on the FDA report.

But enough from me. If you read the editorial, would you let me—and perhaps your elected representatives—know what you think?