FDA Publishes Finalized Guidance Document for Pre-Launch Activities Importation Requests (PLAIR)

On March 2, 2022, the US Food and Drug Administration (FDA) published the finalized guidance document titled, “Pre-Launch Activities Importation Requests,” or PLAIR. This document was updated from the July 2013 draft guidance document. This guidance is intended to aid interested parties in their submissions to FDA requesting importation of unapproved finished drugs in preparation to commence market launch of the new drug in the United States. To qualify, the new drug must have a pending new drug application (NDA), abbreviated new drug application (ANDA), or biologics license application (BLA).

The guidance document discusses how to submit a PLAIR, the importation procedures that follow, and the post-NDA, ANDA, or approved BLA. The PLAIR program is intended to make certain drugs available immediately to patients awaiting approval of the drug. Additional requirements for eligibility include minimal further processing “such as final packaging and/or labeling” or the drug product should be in its final packaged form. This means that parties interested in submitting a PLAIR should have already consulted with FDA’s drug packaging and labeling resources, guidance documents, and regulations.

FDA includes a long list of exactly what needs to be submitted in a PLAIR. The list includes the drug name, the precise quantities to be imported, and the National Drug Code (NDC) number, if assigned. The guidance document also includes a list of drugs that will not be eligible under the PLAIR program such as BLAs not regulated by CDER. Additionally, FDA sets out the relevant timeline for approval. The PLAIR “should be submitted at least 30 days prior to the proposed entry date of the shipment to allow time to process the submission.” There are additional deadlines to be mindful of, which differ based on whether your PLAIR-eligible NDA, ANDA, or BLA is subject to standard review or priority review.

Upon arrival of the drug product, the importer will receive a Notice of FDA Action-Detained. If approved, the importer will receive a Release After Detention notice. If denied, the importer will receive a Notice of FDA Action-Refusal of Admission, and they must export or destroy the drug product within 90 days.

Applicants should consult with legal counsel regarding compliance and any other available recourse. Guidance documents are not binding law, rather they are meant to assist relevant parties in better understanding FDA interpretation of certain regulations and policies. Nevertheless, following the appropriate protocol is key to obtaining permission from FDA for drug and device importation and marketing.