Inspections, Compliance, Enforcement, and Criminal Investigations
Patterson, William M., M.D. 30-Aug-01
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
Rockville MD 20857
CERTIFIED MAIL - RESTRICTED DELIVERY
RETURN RECEIPT REQUESTED
AUGUST 30, 2001
William M. Patterson, M.D.
Birmingham Research Group, Inc.
2120 Lynngate Drive
Birmingham, Alabama 35216
Dear Dr. Patterson:
Between June 12 and 20, 2001, Ms. Patricia S. Smith, representing the Food and Drug Administration (FDA), met with you to review your conduct of the following clinical studies:
1. Protocol [redacted] ("A Double-Blind Placebo-Controlled, Multicenter Study evaluating the Efficacy and Safety of [redacted] in Outpatients with Major Depression"), involving the investigational drug performed for [redacted] and [redacted]
2. Protocol [redacted] (??Flexible Dose Comparison of the Safety and Efficacy If Lu 26-054, Citalopram, and Placebo in the Treatment of Panic Disorder"), involving the investigational drug LU 26-054 (citalopram), performed for Forest Laboratories, Inc.
This inspection is a part of FDA?s Bioresearch Monitoring Program, which includes inspections designed to validate clinical studies on which drug approval maybe based and to assure that the rights and welfare of the human subjects of those studies have been protected.
From our evaluation of the inspection report, and the documents submitted with that report, we conclude that you did not adhere to all pertinent federal regulations and/or good clinical investigational practices. We note that at the conclusion of the inspection, Ms. Smith presented and discussed with you the items listed on Form FDA 483, Inspectional Observations. We remind you that you failed to meet your regulatory obligations as a clinical investigator evidenced by your lack of direct involvement in conducting the studies as follows:
SUMMARY OF VIOLATIONS RELATED TO YOUR FAILURE TO PERSONALLY CONDUCT AND SUPERVISE THE CLINICAL INVESTIGATION (21 CFR 312.60)
1. By signing Form 1572 you agreed to personally conduct and supervise the relevant clinical investigation. You failed to meet this requirement by allowing unqualified coordinators to perform physical examinations in protocol [redacted]. During the inspection, you admitted to our investigator that you did not perform all of the physical examinations but, instead, allowed your study coordinators to perform some of these. You failed to provide documentation to support your position that these coordinators were qualified to conduct the physicals. We are troubled by the fact that this issue of non-qualified personnel performing physical examinations was brought to your attention, during a previous FDA audit in September 1992. By correspondence dated November 24, 1992, this office emphasized to you the importance of delegating study responsibilities, and particularly the conduct of physical examinations, only to those individuals who are appropriately qualified by training and experience to perform those tasks.
2. Three subjects, enrolled in protocols [redacted] and [redacted] stated that they were not seen by you or a physician sub-investigator at any time during their participation in the studies. However, we note that study records contain physical examination findings for these three subjects, signed by you.
We also note that during the inspection, you admitted that you are conducting many studies that you are not able to remember all of them. This suggests that you are not as involved as we would expect of a principal investigator.
Because of your repeated departures from FDA regulations discussed above, please inform this office, in writing, within 15 working days of your receipt of this letter, of the actions you have taken or plan to take to prevent similar violations in the future. Failure to adequately and promptly explain the violations noted above may result in further regulatory action.
If you have any questions, please contact Dr. Antoine El-Hage, at (301) 594-1032, FAX (301) 827-5290. Your written response and any pertinent documentation should be addressed to:
Antoine El-Hage, Ph.D.
Good Clinical Practice II, HFD-47
Division of Scientific Investigations
Office of Medical Policy
Center for Drug Evacuation and Research
7520 Standish Place
Rockville, MD 20855
Martin H. Cohen, M.D.
Division of Scientific Investigations, HFD-45
Office of Medical Policy
Center for Drug Evaluation and Research