Saturday, March 15, 2014

How the FDA Fails to Protect Human Subjects

One year ago, I filed a complaint to the Office of Scientific Investigations about the duplicate "evaluation to sign consent" forms apparently being used in the Department of Psychiatry.  I addressed my complaint to Dana Walters.  After acknowledging receipt of my complaint, Ms. Walters proceeded to ignore my emails and phone calls for a year, before finally sending me a letter this week.

The result?  The FDA has "reviewed my complaint" but will not be telling me what the results of the review are.  Let me repeat that.  I will not be allowed to know the results of my own complaint.  Although, of course, like anyone else, I am free to file a Freedom of Information Request. 

Read the letter for yourself.

***
 
Dear Dr. Elliott,

We have reviewed your complaint. Please note that all activities regarding this matter are confidential, and we are not able to disclose any information.  You may request information regarding this case from the Freedom of Information Office.  The Freedom of Information Act (FOIA) allows members of the public to request publicly available records from federal agencies.  All FOIA requests must be made in writing; FDA does not accept FOIA requests sent via e-mail.  Requests should be mailed to the following address:  Food and Drug Administration, Division of Freedom of Information, Office of Shared Services, Office of Public Information and Library Services, 12420 Parklawn Drive, ELEM-1029, Rockville, MD  20857.  Requests may also be sent via fax to (301) 827-9267.  If you encounter problems while sending a fax, please call (301) 796-3900.  You may also refer to the FDA Web site for instructions: >How to Make a FOIA Request.

Dana L. Walters
Public Health Analyst
Good Clinical Practice Enforcement Branch
Div. of Good Clinical Practice Compliance
Office of Scientific Investigations
OC/CDER/FDA
301-796-3378

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