FDA Warning Letters - Drug Studies


Frequently Asked Questions

[I've included bioequivance studies in this drug list]

Dr. Schworer    11-7-2006 Warning Letter
The PI's failure to retain records of this clinical study made it impossible for FDA to verify the integrity of the data and to verify that there was adequate protection of the rights, welfare, and safety of the subjects who participated in the study. The study data from this site will be excluded from study data reviewed by FDA. I suspect that FDA did not issue a disqualification notice because they could not identify false data.

Dr. Lawrence    11-3-2006 Warning Letter
Drug accountability records must be accurate with respect to both quantities and dates.

The Subject [redacted] Accountability Log documents the return of 90 tablets from 144 tablets dispensed on 10/27/03. However, the [redacted] Drug Accountability Logs case report form reports that 78 tablets were returned.

Subject 015's [redacted] Accountability Log documents the return of 33 tablets on 2/2/04. This however, contradicts the [redacted] Drug Accountability Logs case report form that the 33 tablets were returned on 01/16/04.

Dr. Cristofanilli     6-16-2006 Warning Letter
Failure to file a required IND due to misinterpretation of FDA's regulatory requirements. Next time, call GCP Solutions.

Cell Point, LLC    6-15-2006 Warning Letter
Cell Point was the study sponsor and investigator. There was no evidence of study monitoring. Apparently, the Radioactive Drug Research Committee (RDRC) was also not aware that an IND was required and approved the study without one.

Dr. Campbell     5-18-2006 Notice of Intent to Disqualify
FDA's Office of Criminal Investigations [OCI] determined that Dr. Campbell falsified Case Report Forms (CRFs) that were submitted to the sponsor and falsified documentation to support the existence of a fictitious subject. On October 23, 2003, Dr. Campbell pled guilty to a single count of the indictment to resolve all the charges. Dr. Campbell was sentenced on March 24, 2004 to 57 months in prison, fined $557,251.22, given 3 years supervised release after her prison term is served, and she was ordered to make restitution to Aventis Pharmaceuticals in the amount of $925,774.61. The inspection of Dr. Campbell was October 15 and 24, 2002 nearly 4 years previously. You would think that the 2003 guilty plea would have prompted earlier disqualification. No need to rush; the NIDPOE letter was sent to her in prison at Lexington, KY.

Dr. Hendrick     5-11-2006 Notice of Intent to Disqualify
The submission of false sinus X-ray assessments was the reason for disqualification.

Dr. Rossner     5-10-2006 Notice of Intent to Disqualify
In an affidavit completed during FDA's inspection, Dr. Rossner admitted that subjects 001, 002, and 004 had not signed the informed consent documents and that he had signed these subjects' names on the informed consent documents some time after the subjects were enrolled in the study. As Alfred E. Newman of Mad Magazine would say, "what, me worry?"

"Dr." Phillips     1-20-2006 Notice of Intent to Disqualify
This investigator will be disqualified [but maybe not in my lifetime]. He submitted false information to FDA and the study sponsor. Note that the inspection ended April 3, 2003 and the disqualification letter was issued on January 20, 2006.

Dr. Tidman     12-19-2005 Warning Letter
There's nothing unusual here; protocol compliance was the primary issue.

Dr. Jones     10-27-2005 Warning Letter
This case involved inclusion criteria and the consent forms. The forms for parents and adolescents and the assent form for children did not accurately describe the procedures to be followed.

Dr. McLeod     8-24-2005 Notice of Intent to Disqualify
This investigator will be disqualified. He falsified the dates on multiple subject consent forms.

Dr. Rogers     7-28-2005 Debarment
This case involved convictions for misdemeanors under Federal law for shipping an unapproved new drug for disease, including cancer, in interstate commerce and producing it in an unregistered facility.

Dr. Bishop     6-7-2005 Warning Letter
In this case, Dr. Bishop was the study sponsor and investigator. As a result, his protocol and consent form were deficient. His lawyer was unaware of IND requirements. Dr. Bishop started the study even though FDA told him not to and no IND was in effect -- not a good move.

Dr. Hostoffer     6-6-2005 CBER Warning Letter
There may be some helpful hints in this case regarding drug accountability records.

Dr. Caro Acevedo     8-28-98 Notice of Intent to Disqualify     Debarment 3-24-2005
This case involved convictions for felony violations of Federal law. The CRO and IRB associated with this case received Warning Letters; the IRB for not knowing what was going on in Puerto Rico and the CRO for creating source documents to support CRF entries.

Dr. Hagaman     3-1-2005 Notice of Intent to Disqualify
If you live in Maryland you can't adequately supervise a clinical study going on in Tennessee. The IRB terminated her study. She delegated medical responsibilities to a "Psy.D." and psychologist subinvestigator; a medical physician must be responsible for this and listed on the SF-1572. There was false information submitted to the sponsor.

Dr. Fabre     1-19-2005 Notice of Intent to Disqualify More Info
This was a Bioequivalence study involving a volunteer death. There were multiple problems attributable to a lack of supervision and submission of false information to the sponsor. The IRB who approved Dr. Fabre's study was Human Investigation Committee of Houston, Texas who was sent a Warning Letter a year later. Dr. Fabre is apparently still conducting clinical trials.

Dr. Singleton    2-13-2004 Disqualification
Dr. Singleton was not disqualified; the FDA presiding officer apparently felt that disqualification was too harsh for the infractions cited so he dismantled FDA's Center for Drug Evaluation Research [CDER] case.