Statement of Dr. Sidney Wolfe, Director of Public Citizen’s Health Research Group

In research results released today, the Union of Concerned Scientists (UCS) confirmed a long-standing problem at the U.S. Food and Drug Administration (FDA): Agency workers who analyze drugs for safety and effectiveness are being thwarted in their jobs, and as a result, drugs with questionable safety records are approved for use by millions of Americans.

While the tendency may be to blame the current administration, this problem has been going on well before President Bush took office. In fall of 1998, Public Citizen conducted a similar survey as UCS and found that drug officers then had serious concerns about the safety of the drugs the agency was approving. Then, as now, the officers said that standards had sunk and that drugs were being approved too quickly and without regard for patient safety. Nineteen medical officers identified 27 drugs put on the market during the previous three years that they thought should not have been approved. Eight medical officers reported 14 instances in three years in which they had been instructed not to present their own opinion or data to an FDA advisory committee when doing so might have reduced the likelihood that a drug would be approved. (To read the results of Public Citizen’s survey, click here.)

The culprit is two-fold. First, FDA user fee legislation creates an inherent conflict of interest. Under this legislation, companies – primarily drug companies – this year will pay $380 million to the FDA. An agency cannot effectively regulate industries that pay the salary of so many of its employees. Second, there is a dangerous lack of congressional oversight of the FDA. The last serious oversight hearing was held 20 months ago by Sen. Charles Grassley (R-Iowa). Meanwhile, the agency continues to approve drugs that have no unique benefits but serious risks that can endanger the lives of those who take them, and fails to promptly remove drugs from the market once presented with evidence of dangers. It is inexcusable for Congress to sit idly by while patients die needlessly.

Until user fee legislation is repealed and Congress holds regular oversight hearings – as it used to – the public will see the same survey results repeated in future administrations.