FDA to Monitor Post-Market Drug Safety

Pilot project among proposals agency lays out in response to growing criticism of its operations

By Amanda Gardner
HealthDay Reporter

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TUESDAY, Jan. 30 (HealthDay News) -- In an apparent attempt to address growing criticism of its operations, the U.S. Food and Drug Administration unveiled a set of initiatives Tuesday that are intended to bolster the country's health safety net.

The recommendations include a pilot project to assess the safety of drugs after they're on the market, as well as initiatives to improve communication both within and without the beleaguered agency.

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Speaking of the need to build trust, FDA Commissioner, Dr. Andrew C. von Eschenbach, told reporters at a news conference, "The world is changing, so the FDA must change to continually achieve progress in its ability to determine the safety and effectiveness of the products we regulate. These initiatives today are not the whole story or the final chapter, but they are a major part of the story."

But critics quickly countered that the recommendations didn't go far enough.

"The FDA's [report] includes some minor improvements, such as more sharing of safety data with other agencies, but falls dramatically short of the changes needed to overhaul the nation's drug safety system," senior policy analyst Bill Vaughan of Consumers Union said in a prepared statement.

Many of the initiatives announced Tuesday are in response to recommendations in an Institute of Medicine (IOM) report issued in 2006 and prepared at the request of the FDA. Those recommendations included a push for stronger post-marketing surveillance of approved drugs.

"This report represents our deliberate response to the IOM report," said Randall Lutter, acting deputy commissioner for policy at the FDA, at the news conference. "We are in substantial agreement with most of the IOM recommendations."

In addition to the IOM report, the agency has received substantial criticism for post-market safety questions involving the popular painkiller Vioxx, which was eventually withdrawn from the market, and other drugs.

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