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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Damien Sanderlin, MD 7/27/12

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Center for Biologics Evaluation and Research
1401 Rockville Pike
Rockville, MD 20852-1448 

 

July 27, 2012
 
By Facsimile Transmission and Overnight Delivery              
CBER – 12-08           
 
Damien B. Sanderlin, M.D.
Lone Star Clinical Research
8240 Antoine Street, Suite 107
Houston, Texas 77088
Warning Letter
 
Dear Dr. Sanderlin:
 
This letter describes some of the results of a Food and Drug Administration (FDA, the Agency) inspection conducted between June 21, 2012, and July 18, 2012. The FDA investigator met with you to review your conduct of a clinical study entitled A Multi-Center, Actual Use Clinical Trial of the OraQuick ADVANCE® HIV 1/2 Antibody Test Over-the Counter Product Performance in Untrained Users, Protocol OQ-OTC-5. The FDA conducted this inspection under the agency’s Bioresearch Monitoring Program, which includes inspections designed to review the conduct of research involving investigational devices.
 
At the end of the inspection, the FDA investigator met with you to discuss the items listed on the Form FDA 483, Inspectional Observations. Based on the Form FDA 483 and other information available to the Agency, we have determined that you violated regulations governing the proper conduct of clinical studies involving investigational devices, as published in Title 21, Code of Federal Regulations (CFR) Part 812, (available at http://www.gpoaccess.gov/cfr/index.html). The applicable provisions of the CFR are cited for the violation listed below.
 
You failed to ensure that the investigation was conducted according to the investigational plan, the signed agreement, applicable FDA regulations, and conditions of approval imposed by the Institutional Review Board (IRB) or FDA, this, in order to protect the rights, safety, and welfare of the subjects under your care. [21 CFR §§ 812.100 and 812.110(b)].
 
The Protocol’s Study Design, Section III.L, Follow-up for HIV Positive Test Results, requires the clinical investigator to “comply with all federal, state, and local regulations regarding the reporting of newly-identified HIV positive laboratory results to the Centers for Disease Control and Prevention (CDC).” Eighteen (18) study subjects in Houston, Texas were confirmed HIV positive using FDA-approved methods at the central laboratory, with the first subject being confirmed HIV positive in December 2010, more than 18 months ago. The table below identifies each newly-diagnosed HIV positive subject and the date you signed the central lab report form with a positive HIV test result. Also listed below is the date of Visit 3 for the subjects. According to the protocol, review of the subject’s self test data and laboratory results occurred during Visit 3. All of these subject visits occurred more than one year ago.
 

Subject #/
Initials
Date the central lab  positive HIV test result form was signed by CI
Date of Visit 3
(b)(6)
12/23/2010
12/23/2010
(b)(6)
1/24/2011
1/24/2011
(b)(6)
2/21/2011
2/21/2011
(b)(6)
2/24/2011
2/24/2011
(b)(6)
3/17/2011
3/17/2011
(b)(6)
4/18/2011 and 5/6/2011
4/18/2011
(b)(6)
4/18/2011
4/18/2011
(b)(6)
4/18/2011
4/18/2011
(b)(6)
4/18/2011
4/18/2011
(b)(6)
6/27/2011
6/27/2011
(b)(6)
6/27/2011
6/27/2011
(b)(6)
6/27/2011
6/27/2011
(b)(6)
6/27/2011
6/27/2011
(b)(6)
6/27/2011
6/27/2011
(b)(6)
7/1/2011
7/1/2011
(b)(6)
7/1/2011
7/1/2011
(b)(6)
7/1/2011
7/1/2011
(b)(6)
7/18/2011
7/18/2011

 
The inspection revealed no documentation that you had reported the subjects with HIV positive laboratory results in accordance with state requirements, specifically, the Texas Administrative Code Title 25, Part 1, Chapter 97, Subchapter F, Rule 97.133, which requires you to submit to the State of Texas information for any specimen derived from a human body that yields microscopic, cultural, serological or any other evidence of HIV. According to the Texas Department of State Health Services’ “Technical Assistance Bulletin: Reporting Rapid HIV Test Results” dated March 2010, you are to report positive HIV test results on the Form STD-27 (Department of State Health Services Confidential Report of Sexually Transmitted Diseases Form), and the completed forms are to be sent to the local or regional health authority within seven days of receiving the positive test result. Contrary to what your staff told FDA during the inspection, the CDC does not accept direct reports from individuals. Instead, state health departments, such as the Texas Department of State Health Services, upon receipt of HIV positive laboratory results from within the state, report such surveillance data to the CDC using an electronic HIV/AIDS reporting system.
 
Within fifteen (15) business days of receipt of this letter, please provide written documentation to confirm that you reported the eighteen (18) subjects with HIV positive laboratory results to the Texas Department of State Health Services, along with the dates on which you made these reports. If you did not report some or all of the HIV positive laboratory results to the Texas Department of State Health Services, please provide details regarding that information as well.
 
Please provide specific actions you will take to prevent the recurrence of similar violations in current and future studies for which you are the clinical investigator. Failure to respond to this letter and to take appropriate corrective action could result in FDA taking regulatory action without further notice to you. 
 
The seriousness of the violation referenced in this letter, and its potential public health implications, has caused us to issue this letter prior to a complete review of all of the violations listed on the Form FDA 483 and, as a result, this letter is not intended to be an all‑inclusive list of deficiencies. We are continuing to review information from the two recent inspections conducted at your site (March 27, 2012 through March 29, 2012 and the inspection noted in the first paragraph of this letter). It is your responsibility to ensure adherence to each requirement of the law and relevant FDA regulations.
 
Please send your written response to:
 
Janet White
Division of Inspections and Surveillance (HFM-664)
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
1401 Rockville Pike, Suite 200N
Rockville, Maryland 20852-1488
Telephone: 301-827-6323
 
We also request that you send a copy of your response to the FDA District Office listed below.  
 
 
Sincerely,
/S/
Mary A. Malarkey, Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
 
cc: District Director
      Food and Drug Administration
      4040 North Central Expressway, Suite 300
      Dallas, Texas 75204
 
     Texas Department of State Health Services
     PO Box 149347
     Austin, Texas 78714-9347