Roles and Responsibilities of the CBER Ombudsman
An Ombudsman is a person in an organization charged with investigating complaints and assisting in dispute resolution. In CBER, the position of Ombudsman was established to investigate and act on complaints regarding CBER's regulatory and managed review processes. The Ombudsman is also responsible for maintaining an effective appeals process, and in general responds to problems affecting products under CBER's jurisdiction that have not been resolved through other means. In addition, the CBER Ombudsman collects and analyzes information from inside and outside the Center to assess the effectiveness of programs, to identify deficiencies in those programs, and to ensure that CBER's policy is fairly and evenly applied throughout the Center. The Ombudsman may also advise the Center Director on ways to correct such problems.
The function of the CBER Ombudsman parallels that of the FDA Ombudsman, but provides an avenue for interested parties for getting complaints involving CBER programs resolved at a level closer to the source. The CBER Ombudsman reports directly to the Center Director.
The Food and Drug Administration is committed to resolving differences between sponsors and FDA reviewing divisions with respect to safety and efficacy requirements for drug, device, and biological products as quickly and amicably as possible through the cooperative exchange of information and views.
When administrative or procedural disputes arise regarding biological products, the sponsor should first attempt to resolve the matter with the division and then with the office, if necessary, in the FDA's Center for Biologics Evaluation and Research which is responsible for review of the product. If the dispute is not resolved, the sponsor may raise the matter with the person designated as ombudsman, whose function is to investigate what has happened and to facilitate a timely and equitable resolution.
When scientific or medical disputes arise during the drug investigation process, sponsors should discuss the matter directly with the responsible reviewing officials. If necessary, sponsors may request a meeting with the appropriate reviewing officials and management representatives in order to seek a resolution. Requests for such meetings should be directed to the director of the Division which is responsible for review of the product. The FDA will make every attempt to grant requests for meetings that involve important issues and that can be scheduled at mutually convenient time. If a sponsor is not satisfied with the outcome of that discussion, the matter may be taken to the director of the Office to which the Division reports. The Ombudsman is prepared to facilitate the resolution of disputes or arrange for mediation if the issue remains unresolved. See Related Links.
As described, these dispute resolution processes can take place informally of formally. A sponsor may avail themselves of the formal dispute process at any time after a division director has rendered an unfavorable decision regarding a sponsor's dispute, whereas a sponsor may contact the ombudsman informally at any time during the review process.
When to Contact the CBER Ombudsman Staff:
The Ombudsman primarily receives and investigates complaints from industry representatives and law firms. The CBER Ombudsman's office also wants to hear of problems with CBER programs and suggestions for improvements.
How to Contact the CBER Ombudsman Staff:
CBER Ombudsman: Sheryl Lard-Whiteford, Ph.D.
CBER Assistant Ombudsman: Howard S. Balick, J.D.
Food and Drug Administration
Center for Biologics Evaluation and Research
10903 New Hampshire Ave
Silver Spring, MD 20993-002
General E-mail: [email protected]