FDA Tweaks ‘Deemed to be a License’ Q&A Guidance in Final Version

Regulatory NewsRegulatory News | 04 March 2020 |  By 

In preparation for certain new drug applications (NDAs) to be converted to biologics license applications (BLAs) on 23 March, the US Food and Drug Administration (FDA) on Wednesday finalized a questions and answers (Q&A) guidance on the transition.

The Q&A has been updated to reflect the recent change from the latest appropriations bill, enacted in December, which further amended the definition of “biological product” to include chemically synthesized polypeptides.

The change in the definition effectively means that three additional products will make the transition (in addition to the almost 100 others listed last year). But other companies, like Teva, have requested that FDA include their products in the transition.

For companies with products making the transition, the final guidance explains how they will need to ensure that the listing information for their biological product is updated in FDA’s electronic Drug Registration and Listing System (eDRLS) between 23 March and 30 June, to reflect a change in the prefix of the application number.

“FDA notes that the deeming of an approved NDA to a be a BLA and corresponding update of the eDRLS listing information for the biological product to change the prefix for the application number will not result in the need for a new National Drug Code (NDC) number with a new product code,” the final guidance says.

The agency also says that by retaining products’ current NDC numbers, there will be more consistency for manufacturers and for the databases and pharmacy systems tracking drugs and biologics.

As far as updates to product labeling, the guidance re-works some of the language around question 14 but reiterates that it does not intend to object to the labeling of biological products marketed under a deemed BLA until 23 March 2025.

At the end of the answer for question 15, FDA also adds further information in the final guidance on establishment standards for “non-specified biological products,” which are “subject to certain additional CMC-related requirements under the PHS Act when seeking marketing approval in a BLA or BLA supplement.”

FDA further explains that it does not intend to add a suffix to product names making the NDA to BLA transition, as explained in guidance from last March. And the final version also clarifies the process for submitting follow-up reports on or after 23 March, for any initial field alert report submitted before 23 March.

In addition, the final section of the guidance, on requirements related to labeling, adds a paragraph to note: “After FDA approval of a supplement for the BLA-specific labeling revisions, FDA understands that application holders may need to wait to implement these labeling revisions until their next printing of the labels and labeling. Accordingly, to enable such application holders to exhaust existing inventory, FDA generally does not intend to object to the labeling of biological products that are marketed under a deemed BLA where FDA has already approved a supplement that includes the BLA-specific labeling revisions but the labels and labeling do not include the BLA-specific labeling revisions prior to March 22, 2025.”

The “Deemed to be a License” Provision of the BPCI Act: Questions and Answers

Purple Book Comments

In addition to the final guidance, FDA also is seeking further input on how it should continue to revamp its Purple Book for biologics, which was recently converted from a .pdf document to a searchable website.

“Taking user testing and stakeholder input into consideration, the enhanced Purple Book is expected ultimately to include all Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) regulated biological products, including transition products, in addition to enhanced functionality. A later release of the enhanced Purple Book will include determinations that have been made pertaining to exclusivity,” FDA said.

FDA is seeking comments on if the new database is user-friendly enough, whether it helps improve stakeholders’ understanding of biologics, which functionalities are most useful and what other types of information would be helpful to include.

Withdrawn Guidance

FDA on Wednesday also said it will withdraw a 2006 guidance for industry entitled “Exocrine Pancreatic Insufficiency Drug Products-Submitting NDAs,” because an NDA for such a product may not be submitted after 23 March.

“Sponsors interested in submitting a biologics license application (BLA) for a proposed PEP should contact the Agency with any questions,” the agency said, noting the guidance will be effectively withdrawn on 23 March. “Products containing pancreatin or pancrelipase fall within FDA’s interpretation of the term ‘protein’ in the statutory definition of a biological product.”

And FDA said that it intends to issue guidance on “how the concepts described in the withdrawn guidance would apply to proposed pancreatic enzyme products submitted under the PHS Act, including the extent of integration of various types of data and information about the use of PEPs into BLAs.”


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