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Release: July 23, 2001

UI releases details of 1999 letter from Food and Drug Administration

IOWA CITY, Iowa — In addition to releasing a statement questioning the accuracy of a headline in a July 22 article in the Des Moines Sunday Register, University of Iowa officials today released information about the Food and Drug Administration (FDA) letter that was the basis for the Register’s story.

The Register’s story was apparently precipitated, in part, by a letter to the university that has been posted on the FDA’s web site since 1999. Posting such letters is a standard part of the FDA’s Freedom of Information process. The site, however, does not post subsequent correspondence demonstrating the dialogue between the university and the agency and resolution of the FDA’s concerns.

The FDA’s letter, dated June 18, 1999, refers to a regular investigation that took place between Feb. 2 and June 23, 1998. The letter says, in part: "We apologize for the delay in providing you with an official notice of the results of the inspection. Even at this late date, the significance of the following violations are of particular importance because many of them have been observed during past inspections where corrections were promised by your institution but not implemented."

That language alarmed university officials, who said it directly contradicted what they had been told by an FDA inspector during an on-campus meeting in May of 1998.

In a letter of response to the FDA dated July 27, 1999, UI Vice President for Research David Skorton wrote: "We are surprised by that statement because the University of Iowa has expended considerable effort to address all prior FDA concerns that were detailed in your June 18 letter. And, in interview minutes dated May 1, 1998, provided by the FDA to the university, Mr. Iwen [FDA investigator John A. Iwen] stated, ‘The items listed in the pervious inspection either appear to have been corrected or were not noted during this inspection.’"

Some of the violations concerned minutes of meetings for the university’s Institutional Review Board, which must approve all research involving human subjects. In some cases, the minutes did not record votes of everyone at the meeting. The university was able to respond by providing evidence that some members who were present at the meeting chose not to vote on specific projects, as is their right.

Another violation concerned the identification of committee members with the same last name. The FDA citation noted that the minutes should have included the first initial of the person in attendance. The university has subsequently followed that recommended procedure.

The FDA’s letter also raised a concern that the university’s Institutional Review Board used an expedited process to add a statement into a consent form for human research participants. The addition noted that patients should be aware that the FDA could copy and inspect research records.

In its response, the university noted that FDA guidelines allow for such expedited modifications. In addition, the university explained that the change was implemented before the beginning of the research program cited in the letter from the FDA. All research participants involved in that study signed a consent form that contained the required language, the university noted.

The FDA accepted information provided by the university, and the matter was closed in November of 1999.