Successfully Navigating the FDA Formal Dispute Resolution Process to Approval

Posted 01 October 2009 | By

During the development of drugs and biologics, disputes (including scientific and procedural disagreements) between US Food and Drug Administration (FDA) division reviewers and sponsors are bound to occur. When the sponsor is unable to resolve such disputes within the division itself, it has the option of appealing to a higher level within FDA. In February 2000, FDA issued Guidance for Industry: Formal Dispute Resolution: Appeals Above the Division Level. This guidance provides a mechanism for sponsors to appeal their position to the appropriate office director and even up to the center director, if the appeal to the office director is unsuccessful. Depending upon the complexity of the particular issue under discussion, the dispute resolution process may take months to years. However, if a sponsor has a compelling argument that is supported by data and the resolve to endure the long process, a successful and mutually acceptable outcome may be realized. Such was the case of FDA's approval of MS-325 (formerly Vasovist®; gadofosveset trisodium), a contrast agent developed by EPIX Pharmaceuticals Inc. (the New Drug Application (NDA) sponsor) and now marketed by Lantheus Medical Imaging as Ablavar. The sponsor challenged the original decisions by the division reviewers and elected to initiate the dispute resolution process. MS-325 was ultimately the first contrast agent approved for use with magnetic resonance angiography in the evaluation of aortoiliac disease in patients with known or suspected peripheral vascular disease.

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