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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Weese-Mayer, Debra, MD Warning Letter Response

RUSH UNIVERSITY MEDICAL CENTER

Children's Hospital 1653 West Congress Parkway Tel: 312.942 .2723
Pediatric Respiratory Medicine Chicago, Illinois 60612-3833 Fax 312-942-3087

3 November 2005

Mr. Timothy A. Ulatowski
Director, Office of Compliance
Food and Drug Administration
Center for Devices and Radiological Health
2098 Gaither Road
Rockville, Maryland 20850

Re:[redacted]

Dear Mr. Ulatowski:

I am responding to the Warning Letter you sent to me dated 14 October 2005, received by me on 17 October 2005.

I have recently reviewed these issues with the staff of the Office for Human Research Protection and the Office of Research Compliance at Rush University Medical Center. We have reviewed this entire device study, all my study and regulatory files, the Form FDA 483 issued by the Chicago District Office in July 2005, and the Warning Letter issued by the Centers for Devices and Radiological Health to [redacted] in August 2005.

As a result I have a better understanding of FDA regulations, Principal Investigator responsibilities, and the specifics of the 14 October 2005 Warning Letter. I do not dispute any of the deviations itemized in the 14 October 2005 Warning Letter. I agree that in these areas I did not always fulfill the responsibilities of a Principal Investigator as defined by FDA regulations:

I did not obtain proper informed consent prior to study procedures in the compassionate use subject in 1992 and in the verbal consent subject also in 1992;

  • My investigation was not always conducted according to the signed agreement, the investigational plan, and applicable FDA regulations, though -it was always
    conducted with complete attention to patient safety and care;

  • I did not submit timely progress reports on the investigation to the sponsor, the monitor, and the reviewing IRB in 1993 and 1997;

  • I did not always maintain accurate, complete, and current case report forms in the case histories; and

  • I did not maintain adequate records of device receipt, use, and disposition.

  • I do not dispute any of the specific examples of these shortcomings cited in the 14 October 2005 Warning Letter.

Thank you for the clarifications about the distinction in the FDA device regulations between "Emergency Use of Unapproved Medical Devices" and "Compassionate Use." Clearly the example cited in your letter was an example of proposed "Compassionate Use," and should have followed all the guidelines that you summarized.

I have implemented the following policies and procedures to ensure that these deviations are corrected and will not occur in the future :

  • In 1993 (after the two examples of improper consent cited) I implemented a policy to ensure that no research subject is taken to the Operating Room for [redacted] until one of my staff has verified that the parents have signed the IRB-approved informed consent document, the child (if appropriate) has signed the IRB-approved assent document, and a study physician and witness have counter-signed that consent and assent (copy of policy enclosed).

  • Once [redacted] instructed me that I am required to report the two deaths cited as Serious Adverse Events, even though the deaths occurred in situations unrelated to diaphragm pacing, I immediately submitted completed Safety Report Forms to the Rush IRB (copies enclosed) on 7 July 2005.

  • I have written and implemented a policy to assure that every single Case Report Form (including "registration forms') is placed in subject study charts (copy of policy enclosed).

  • Benefiting from [redacted] instructions, I created a notebook for device receipt, use, and disposition on 7 July 2005. Representative pages from that notebook are enclosed.

In the Warning Letter, you asked me to develop and implement a training program to ensure these deviations are corrected and will not occur in the future. In Appendix I, I have outlined the training program I have developed in consultation with the staff of the Office for Human Research Protection and the Office of Research Compliance at Rush University Medical Center.

In the Warning Letter, you also asked me to list my current investigational studies, with the name of the study sponsor and the date of IRB approval. Please find that I have listed all this information as the enclosed Appendix II.

I understand the gravity of the deviations documented by the Chicago District office inspector in June-July 2005, and cited in the Warning Letter of 14 October 2005. I now have a much different and much more complete understanding of the responsibilities of a Principal Investigator as defined by the FDA regulations (21 CFR 50, 56, 312, 812, and more), and specifically a much different and much more complete understanding of the responsibilities of a Principal Investigator working with an IDE device. I will devote considerable time, energy, and attention to my remedial training over the next two months, as outlined in Appendix I.

Please do not hesitate to contact me if any fiirther information is needed.

Very sincerely yours,

/s/
Debra E. Weese-Mayer, M.D.
Professor of Pediatrics
Rush University