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Report Faults FDA on Drug Safety

By Christopher Lee, Washington Post Staff Writer

Five experts who have advised the Food and Drug Administration on drug safety yesterday threw their weight behind mounting criticism that the agency does not adequately protect the public from unsafe drugs.


The experts, all current or former members of the agency's Drug Safety and Risk Management Advisory Committee, said FDA-mandated safety studies can miss serious problems with a drug both before and after its approval. The agency does not have the authority to pull dangerous drugs unilaterally, force changes in drug labels or sanction drug companies that skimp on safety monitoring, the experts said.

The group, which published its critique yesterday in the Archives of Internal Medicine, also contended that the FDA lacks the money and structure to insulate itself from the influence of the pharmaceutical industry.

The findings are similar to those released last month by the congressionally chartered Institute of Medicine, which found that the system for approving and regulating drugs is in serious disrepair. That report, requested by the FDA, followed two years of controversy over drug safety after the 2004 withdrawal of the arthritis drug Vioxx because of the risk of heart attack.

"The FDA has for the past decade been aware of these problems; they've done very little to fix them," said Curt D. Furberg, a professor of medicine at Wake Forest University and a member of the drug safety advisory panel.

Joining Furberg in the critical paper were current panelists Robyn S. Shapiro and Arthur A. Levin, and former members Peter A. Gross and Brian L. Strom.

Steven Galson, director of the FDA's Center for Drug Evaluation and Research (CDER), which reviews drug applications and monitors drugs once they are on the market, said he disagrees with some of the findings but not with the overall message that the FDA should focus more on drug safety. "We could improve the way that we handle drug safety by putting more people on the assessments and improving the science behind those assessments," he said. "And that is not just on FDA's shoulders -- it's on the whole drug development enterprise."

Both the Institute of Medicine and the five experts would ban consumer advertising of newly approved classes of drugs until they have been on the market long enough for any problems to emerge; give the agency new powers to fine drugmakers that fail to complete required safety studies; and take steps to limit conflicts of interest and broaden the range of expertise on panels appointed by the agency to review scientific data on proposed drugs.

But the experts went further by calling for a Center for Drug Safety outside of the CDER and increased FDA funding for safety monitoring, perhaps through a fee of a few cents on every prescription. They also recommend giving "conditional approval" to some drugs to require drugmakers to demonstrate a drug's safety or else risk seeing it pulled from the market.

Galson called conditional approval "intriguing" but is opposed to a new center. "Creating a new bureaucracy is rarely the right answer," he said. "It would create new walls, new structures that would make it more difficult for our staff to interact with one another."

Alan Goldhammer, a spokesman for the Pharmaceutical Research and Manufacturers of America, said insurers might not cover drugs with conditional approval, depriving patients of new therapies. While safety efforts could be more "proactive," the FDA must strike the right balance, he said.

"Drugs are approved on both the benefit and the risk, and if the agency becomes too risk-averse, it runs the risk of not approving important new drugs that could benefit patients."

Many of the recommendations would require action by Congress. Senate Finance Committee Chairman Charles E. Grassley (R-Iowa) has sponsored legislation that would give the FDA more authority to monitor safety after a drug hits the market. "Both Congress and the administration need to take action to refocus the FDA's drug-safety work and to end the agency's too-cozy relationship with the drug companies," he said.

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