The United States Food and Drug Administration (FDA) recently issued two guidances as part of its Drug Competition Action Plan (DCAP), aimed at streamlining the premarket review and approval process for generic drug sponsors.
Revising ANDA Labeling
One guidance document, Revising ANDA Labeling Following Revision of the RLD Labeling Guidance for Industry, aims to help applicants and holders of abbreviated new drug applications (ANDA) in updating their labeling after revisions to the approved labeling of a reference listed drug (RLD). It includes recommendations on identifying RLD labeling updates and submitting ANDA amendments or supplements to update generic drug labeling.
Under FDA regulations, an ANDA holder is expected to update its own labeling after the FDA approves relevant changes to the labeling for the RLD. Because the labeling of the generic drug must be the same as the labeling for the RLD, the revision should be made as soon as possible (with the exception of permissible differences).
This guidance finalizes draft guidance for industry that was issued in January 2022, which had revised the “Revising ANDA Labeling Following Revision of the RLD Labeling” issued in April 2000. Minor revisions from the draft guidance to the final guidance were made to improve clarity.
Amendments and Requests for Final Approval to Tentatively Approved ANDAs
The second guidance document, ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs, is intended to help applicants prepare and submit amendments to tentatively approved ANDAs – including requests for final approval. The guidance document includes recommendations on the timing and content of amendments to tentatively approved ANDAs to help ensure submission in a timely fashion to allow for final approval on the earliest date on which the ANDA may be lawfully approved based on patent and/or exclusivity protections.
In the guidance, the FDA outlines policies based on performance goals under the latest Generic Drug User Fee Amendment (GDUFA III) and discusses how the agency expects to address ANDA sponsor requests for final approval that meet those expectations. It also clarifies the patent certification process and exclusivities and how they may impact ANDA approval times. The FDA notes that “an ANDA must contain an appropriate patent certification for each patent that claims the RLD or a method of using the RLD for which the ANDA applicant seeks approval in its ANDA and for which the NDA applicant is required to submit information.”
Additionally, the guidance states that the sponsor must submit one of four certifications to the FDA regarding the patent: a certification that the patent information has not been filed, a certification that the patent has expired, a certification that details when the patent will expire, or a certification that the patent is invalid, unenforceable or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted. If a sponsor submits one of the first two types of certifications, it should not delay their ANDA approval, but if a sponsor submits the third type, they will need to wait until the patent expires. Submitting the fourth type will mandate that a sponsor provide the NDA holder and each patent owner with notification of its certification, including a description of the legal and factual basis for the ANDA applicant’s assertion that the patent is invalid, unenforceable, or will not be infringed.
This updates the final guidance for industry that was issued in September 2020 by the same name.