How Do You File a Complaint About FDA?
“If you believe an FDA employee is not following FDA’s Good Guidance Practice regulations (21 CFR 10.115) or the Office of Management and Budget’s Bulletin No. 07-02(M-07-07) Final Bulletin for Agency Good Guidance Practices (January 18, 2007), you should contact the employee’s supervisor in the issuing office or Center. If the issue is not resolved, contact the next highest supervisor or the Center’s Ombudsman. If the issue is still not resolved, contact the FDA’s Office of the Ombudsman at:
FDA Office of the Ombudsman
5600 Fishers Lane, Rm. 13B-07
Rockville, MD 20857
Phone: 301-827-3390
Fax: 301-480-8039
Email: Ombuds@oc.fda.gov
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I would like to note that you can use the Office of the Ombudsman confidentially if you choose.
UPDATE: I have had two very good comments on this topic. You can read both, with my responses on the comments page. I welcome your comments as well. One comment is from a European colleague, Eldin Rammel, and the other is from former FDA National Expert Bob Coleman, who certainly has more experience on this than I do. I thought it should come up from the comments page. Here is Bob’s advice:
Carl, I am painfully aware that there are some FDA personnel that often overstep their authority while conducting investigations/inspections. While I was with the FDA, I often would receive information to that effect from various companies, many of the complaints for the most outrageous allegations. My response to them was that they needed to arrange for a meeting (face-to-face) with the Director of Investigations (if it was a foreign firm) or the District Director for domestic facilities to discuss the details of what happened for resolution. Unfortunately, many do not choose to do so (perhaps out of a sense of retribution – which if that ever occured would be intolerable). I have advised those impacted that unless they take their complaint directly to FDA, then nothing can or will be done.
Bob
On a different note I am going to discontinue the “Facebook Fans” site because of privacy concerns. I have started a LinkedIn Group which I hope you will join. LinkedIn is a more secure site than Facebook currently is.
GxP Perspectives LinkedIn Group
The fear of retribution is such a powerful factor in an inspection. Within Europe we have for several years now seen inspectors push the boundaries of interpretation of GCP, particularly with respect to (a) the scope of the trial master file, (b) the management of electronic records, and (c) the construction and protection of physical archives. For the sponsor, it is extremely difficult to suggest to the inspection team that you think they may be wrong. Perhaps this situation is actually more commonplace outside of the USA, since there is more secrecy involved (e.g. no 483′s posted on a website, subject to scrutiny by the public).
I agree with Eldin although I am less familiar with events in Europe. Eldin is a records specialist in the UK and listed under “Consultants” on the right, beneath the Blogroll. I have certainly heard of some tough European inspections lately, particularly by MHRA in the UK.
Carl, I am painfully aware that there are some FDA personnel that often overstep their authority while conducting investigations/inspections. While I was with the FDA, I often would receive information to that effect from various companies, many of the complaints for the most outrageous allegations. My response to them was that they needed to arrange for a meeting (face-to-face) with the Director of Investigations (if it was a foreign firm) or the District Director for domestic facilities to discuss the details of what happened for resolution. Unfortunately, many do not choose to do so (perhaps out of a sense of retribution – which if that ever occured would be intolerable). I have advised those impacted that unless they take their complaint directly to FDA, then nothing can or will be done.
Bob
This comment comes from a respected colleague with a lot of experience on this issue.