Report assails FDA oversight of clinical trials

In each case, the size and complexity of the tasks facing the agency have grown enormously as the number of inspectors for those tasks has generally declined.

An inspector general’s report in 2000 criticized the oversight of clinical trials and noted that the inspections mostly focused on whether study information was accurate and not on whether human subjects were protected. That is still true.

In the present report, the inspector general recommended that the agency create a registry of all continuing clinical trials, an idea signed into law by President Bush on Thursday.

The report also recommended that the agency create a complete registry of research ethics boards, create a single comprehensive database to track its research inspections and obtain greater authority to regulate research assistants.

Senator Charles E. Grassley, Republican of Iowa, said the agency “needs to implement these recommendations to meet its duty.”

Representative Rosa DeLauro, Democrat of Connecticut, said it needed more money and guts.

“They’re passive, they’re reactive, and they often side with industry over public health,” Ms. DeLauro said.

The agency’s reserve is apparent in some of its warning letters.

On May 24, 2005, an inspector, Barbara Breithaupt, went to the office of Dr. Frank A. Wingrove of Ames, Iowa, and for weeks asked to see records of his study of an experimental topical treatment for periodontal disease. Dr. Wingrove refused. Dr. Wingrove did not return telephone messages seeking comment.

More than two years later, the agency sent Dr. Wingrove a warning letter. The inspector general’s report suggests that if Dr. Wingrove promised to reform, the agency was unlikely to show up again to see whether he had followed through.

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