On December 11, 2018, FDA issued draft guidance on questions and answers about the “deemed to be a license” provision of BPCIA. FDA intends the guidance to answer common questions about FDA’s interpretation of the provision.

The questions for which FDA provides answers relate to identification of products subject to the provision; NDAs for biological products submitted on or before the transition date of March 23, 2020; the statutory and regulatory requirements for BLAs; the transition of biological products from the Orange Book to the Purple Book; and designation of a proper name for affected products. For example, FDA explains that it is posting and updating a list of approved NDAs that will be affected by the provision on its website. FDA also explains that on the transition date, it will send letters to sponsors of affected approved NDAs, advising them that the approved NDA no longer exists and that it was deemed to be a BLA. In addition, FDA explains that it will remove affected products from the Orange Book on the transition date and list them in the Purple Book shortly thereafter.

More information about the provision can be found in FDA’s final guidance on its interpretation of the provision and Finnegan’s related IP FDA Blog post.

Comments on the draft guidance by FDA Commissioner Scott Gottlieb can be found here. Readers are encouraged to read the draft guidance, also available on FDA’s website.