Problems With FDA: Process for Complaints


FDA complaint process

How Do You File a Complaint About FDA?

Lately I have encountered colleagues and clients who have had problems with an FDA inspection. One result is that they do not know the process to file a complaint or they fear retribution if they do complain about an FDA inspection. I discussed this briefly in a previous post on how long an FDA inspection should take. But it is more than the length of the inspections. It is that some FDA field investigators are not prepared for conducting an inspection in a clinical trial’s therapeutic area and that a few field investigators (a very small minority) use abusive inspection tactics. Fortunately FDA has a process for fielding complaints. Here is what they say, in FDA’s inimitable manner:

“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

We have redesigned the FDA Web site. As a result, some Web links (URLs) embedded within guidance documents are no longer valid. If you find a link that does not work, please try searching for the document using the document title. For more assistance, go to Contact FDA.”

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

Share/Bookmark

4 Responses to Problems With FDA: Process for Complaints

  1. 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).

    • GxP Perspectives says:

      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.

  2. Bob Coleman says:

    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

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

%d bloggers like this: