- FDA Draft Guidance Describes Procedures, Policies for Resolving Scientific and Medical Disputes
- October 19, 2015 | Author: Scott S. Liebman
- Law Firm: Loeb & Loeb LLP - Washington Office
- The agency issued guidance on the resolution of disputes that arise from disagreements between sponsors and the CDER or CBER, going over the procedures in the CDER and CBER for resolving scientific and/or medical disputes that can’t be settled at the decision level.
In its guidance document, the FDA describes the formal dispute resolution (FDR) procedures for appealing issues to the office or center level.
The document notes there are occasions over the course of review of an IND, NDA, BLA or ANDA, during which a range of scientific and medical issues are discussed, where there is a disagreement between a sponsor and the FDA on a matter. The disputes that arise from the disagreements often concern complex scientific and medical matters, so procedures must be in place to ensure “open, prompt discussion of such disputes,” the FDA says.
In going over considerations regarding the submission of a formal dispute resolution request, the FDA enumerates five points sponsors should weigh prior to submitting a formal dispute resolution request (FDRR). First, the document addresses what an appropriate FDRR matter is, listing complete response letters and denials of a request for a proprietary name as examples of regulatory actions appropriate for FDRRs. Second, the FDA discusses when a matter isn’t appropriate for an FDRR, noting that advice communicated in meeting minutes and general advice letters isn’t considered a CDER or CBER regulatory action and therefore isn’t suitable for a request. FDRRs also won’t be accepted if a sponsor hasn’t sought reconsideration of an issue, is engaged with other FDA entities and/or is pursuing other pathways on the same matter simultaneously. The document also talks about new information, noting the review of a decision that was appealed needs to be based on the same information relied on to make the original decision. Thus, new information can’t be submitted as part of an FDRR, but rather can be submitted to an application for review by the original deciding official, should the sponsor wish to have the CDER or CBER consider it in case it may affect the original decision. The FDA also addresses meetings related to FDRRs, noting sponsors can request a meeting with an appeal’s deciding official after submitting an FDRR to discuss the issues at hand. Sponsors can also request that an advisory committee review a scientific dispute.
The FDA also describes submission procedures, explaining how sponsors can request an FDRR. In addition, the document covers content and format, listing elements that should be contained in each request, including the application number, a brief but “comprehensive” statement about each issue to be resolved and a statement of whether an advisory committee review is requested, among others.
Also included in the document is information concerning FDA action, including responses to an appeal and additional considerations about responses to appeals. The FDA notes the Formal Dispute Resolution Project Manager or CBER Ombudsman serve as the contact for all FDRR-related issues and will communicate and explain to the sponsor all regulatory processes relating to an FDR. If the FDRR is accepted, the appeal will be forwarded to the appropriate CDER or CBER management level, and an acknowledgment letter will be sent to the sponsor identifying the deciding official, due date for response and the date of a meeting, if applicable. In the event that an FDRR is declined, the sponsor will be notified in a letter and informed of the reason for the denial.
The document ends with information about repeat appeals, with the FDA noting that if a sponsor’s FDRR isn’t accepted at one management level, the sponsor can appeal the same matter to the next higher management level.