Alerts and Updates

Where a change to a drug application results from a corporate merger or acquisition, the OGD staff will not consider such a change to be a transfer of ownership.

The U.S. Food & Drug Administration (FDA) recently issued a new Manual of Policies and Procedures (MAPP), in which it explains the Office of Generic Drugs’ (OGD) policy on facilitating changes to generic drug applications and updating the Orange Book to reflect those changes.

MAPP 5242.1 makes clear that the policies, processes and procedures for changing ownership of an application differ based on whether the change is effected by a simple transfer of ownership or whether it results from a corporate merger or acquisition.

Requests for Transfer of Ownership (Under 21 C.F.R. 314.72)

Where a current application owner requests a transfer of ownership to a separate, unrelated entity under 21 C.F.R 314.72, OGD staff will confirm that (1) the current (to-be former) owner has submitted a letter or document stating that all rights have been transferred to the new owner, evidenced in part by the former owner’s submission of a “transfer of ownership” form along with a list of the applications to be transferred, and (2) the new owner has submitted an application form along with a letter or other document containing their commitment to agreements, promises and conditions made by the former owner and contained in the application, along with the effective date of the change in ownership and confirmation that the new owner has a complete set of the application.

OGD staff will also determine whether the new owner has submitted documents to FDA concerning any changes in the conditions of the approved application and will confirm that the new owner has subtitled an acceptance letter for the newly acquired applications. After confirming it has all required information and documentation, the OGD staff will process the request for a change in ownership and update the Orange Book accordingly.

Changes Arising from Corporate Mergers or Acquisitions

Where a change to a drug application results from a corporate merger or acquisition, the OGD staff will not consider such a change to be a transfer of ownership. Changes to applications caused by a merger or acquisition are effected by the applicant requesting (1) a corporate name change, (2) a change in address and/or (3) a change in contact information.

A request for any of these is submitted with Form FDA 356h, along with a cover letter that identifies (1) the type of submission (i.e., corporate name change), (2) the date of the merger or acquisition, (3) the new name, address or contact information and (4) if applicable, each of the applications affected by the change. OGD staff will verify that all of the required information has been received and will notify the application holder of any outstanding information. After confirming that it has all of the required information and documentation, the OGD staff will process the request for a change in ownership and update the Orange Book accordingly.