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 (see Ombuds Principles and Code of Ethics section).
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 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. Guidance on how to pursue the formal dispute resolution pathway can be found in the draft Guidance for Industry – Formal Dispute Resolution: Appeals Above the Division Level (PDF - 241KB).
The request for formal dispute resolution should be submitted to the appropriate review division as an amendment to the application (e.g., IND, NDA, ANDA, BLA), with a copy to the CDER Formal Dispute Resolution Project Manager (FDRPM), Amy Bertha. We encourage sponsors to contact the FDRPM before submitting a request for formal dispute resolution.
Contact Information for the FDRPM:
CDER Formal Dispute Resolution Project Manager
10903 New Hampshire Avenue
White Oak Building 22, Room 6486
Silver Spring, MD 20993-0002
E-mail address: ONDEIO@fda.hhs.gov
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: