Anyone having interactions with CDER should find our staff professional and helpful and our decisions based on sound science and policy. Given that expectation, there will still be instances when an individual or company disagrees with a decision or action or feels that they have been treated unfairly. There are several paths available to you to attempt resolution of a dispute and the Ombudsman is your one-stop shop to review those options and get practical advice.
Although some might think of contacting the Ombudsman as a last resort, keep in mind that the earlier you contact the Ombudsman, the more options might be available for addressing your problem. This is particularly important if there are statutory, regulatory, or administrative time constraints. If requested, the Ombudsman can keep the exchange confidential.
As stated on the FDA Ombudsman’s website, “FDA is committed to the principle that regulated industry has a right to disagree with an agency decision, action, or operation, and that full and open discussion of issues in controversy produces a better decision in the end. Moreover, regulated industry is entitled to receive high quality administrative practices and procedures from all parts of FDA.”
If you are experiencing a problem with one of our Divisions/Offices, the Ombudsman strongly suggests that you first discuss it with the review team and Division/Office Director, as appropriate. A meeting with the review team and Division/Office Director can be a productive way to address your issue. When requesting a meeting with CDER personnel, you should refer to the Guidance for Industry: Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products (PDF - 336KB) which describes procedures and timeframes. If your product falls under BSUFA, please review the draft Guidance for Industry: Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants (PDF - 272KB).
If you are not satisfied with the outcome of that discussion, you may then take the matter to the CDER Ombudsman to discuss your options, one of which is for the Ombuds to informally investigate and facilitate resolution, either through shuttle diplomacy or mediation. You are encouraged to contact the Ombuds, but, alternatively, you may raise the matter up the management chain by either contacting the director of the Office to which the Division/Office reports or invoking the formal dispute resolution process. Information on how to pursue the formal dispute resolution pathway can be found on the CDER Formal Dispute Resolution webpage.
The CDER Ombudsman also has a role in resolution of scientific differences of opinion internal to FDA. These procedures are detailed in the following CDER Manuals of Policies and Procedures and FDA Staff Manual Guides: