FDA Bans Seven Investigators

FDA has banned seven doctors from doing clinical trials so far this year. That is the highest number since 2002, you can see the entire disqualification list at  http://www.fda.gov/ora/compliance_ref/bimo/disqlist.htm. Physicians or other medical professionals are banned from conducting clinical trials that will result in data being submitted to FDA; put another way, these people can still do clinical research, but no data generated by them can be used to support an FDA marketing application. Which means that medical device companies who have ongoing clinical trials with these investigators, or are considering using these investigators, should look elsewhere.

   

The list of investigators banned in 2008 is:

01/31/2008 Jamie Kapner, M.D.—Urologist, Scottsdale, AZ
02/15/2008 Bertrand Agus, M.D.—Rheumatologist at New York University
02/25/2008 Stephen D. Rossner, M.D.—Cardiology Associates of Central Connecticut
03/05/2008 William H. Ziering, M.D.—Pediatric Allergist, Central California Research Institute
03/05/2008 Mary Sawaya—Dermatologist, University of Florida, Miami, FL
03/21/2008 Patrick J. Daley—Pediatrician, Tulsa, OK
04/28/2008 Manjeet Kaur Achreja, M.D.—Family Medicine, Seagrove, NC
05/06/2008 David N. Lofgren, M.D.—Pediatrics, Sandy, UT
05/15/2008 James C. Vestal, M.D.—Urologist, Urology Associates of North Texas
06/02/2008 Maria Anne Kirkman Campbell, M.D.—Weight Loss Clinic, AL

The physicians come from various walks of medicine, but all contributed to fraudulent data being submitted to FDA. Fraudulent data is the omission of data, the fabrication of data, or the alteration of data. It can be committed by anyone who has contact with the data, but is usually committed by someone likely to experience financial gain. Investigative sites should be audited by third-party CROs whenever data are pivotal to proving your device's success. For information about site audits contact CDG.