The US Food and Drug Administration (FDA) recently issued a new Manual of Policies and Procedures (MAPP) which outlines how the Office of Generic Drugs (OGD) will process requests to transfer ownership of generic drug applications, and how it will update the Orange Book to reflect those changes.
MAPP 5242.1 details the policies and processes for changing ownership of an application according to whether the change will involve a simple transfer of ownership or whether it results from a corporate merger or acquisition.
Transfer of ownership requests
When the current owner of an application requests a transfer of ownership to an unrelated entity under 21 CFR 314.72, the new and current (to-be former) application owners are required to submit information to FDA.
Orange Book project managers and pharmacists in OGD will ensure that the former owner has submitted: a letter or document stating that all rights have been transferred to the new owner, a change of ownership request (generally a stand-alone "Transfer of Ownership" form), and a consolidated list of the applications to be transferred. OGD staff will also confirm that the new owner has submitted a signed application form along with a document containing: their commitment to agreements, promises and conditions made by the former owner and contained in the application, the date the change in ownership is effective, and confirmation that the new owner has a complete copy of the approved application.
OGD staff will determine whether the new owner has submitted documents to FDA regarding any changes in the conditions of the approved application. They will also confirm that the new owner has subtitled an acceptance letter for the newly acquired applications.
Changes due to corporate mergers or acquisitions
FDA will not consider changes to drug applications resulting from a corporate merger or acquisition to be a transfer in ownership. In general, changes to applications caused by a merger or acquisition are effected by the applicant requesting either a corporate name change, a change in address and/or a change in contact information.
Requests for any of the above are submitted with a Form FDA 356h, accompanied by a cover letter that identifies the type of submission, e.g. corporate name change, the date of the merger or acquisition, the new name, address or contact information and, if applicable, a list of the applications affected by the change.
For both types of changes to drug applications, OGD staff will review all the documentation and notify the new application holder if any information has been omitted. Once an OGD pharmacist has verified all of the required documentation, OGD project managers will process requests for changes in ownership and requests for changes in application information relating to corporate mergers and acquisitions by updating the Orange Book database.
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