FDA's Draft Guidance For Industry On Pre-Launch Activities Importation Requests: Dead On Arrival?

On July 25, 2013, the Food and Drug Administration ("FDA" or "the Agency") published a Draft Guidance for Industry entitled "Pre-Launch Activities Importation Requests", or "PLAIR". The draft guidance describes FDA policy on requests for importation of unapproved finished dosage form drug products by an applicant preparing for market launch pursuant to a New Drug Application ("NDA"), an Abbreviated New Drug Application ("ANDA") or a Biologics License Application ("BLA"). The draft guidance describes the procedure for making requests for importation prior to approval, as well as the factors FDA will look to in deciding whether to grant such requests.

Under the PLAIR program, an applicant with a pending NDA, AND or BLA would submit a request to the Agency requesting permission to allow it to import the finished drug product subjected to the application to allow it to prepare it for market launch. If the PLAIR request is granted, the applicant would be permitted to import the product, but FDA would formally detain it on entry. At that point, FDA would:

.....regard the PLAIR request to mean that the owner or consignee has requested to recondition the drug by obtaining FDA approval of the pending application, as specified in the PLAIR request FDA has granted. FDA will thus detain the drug for up to 6 months pending a decision on the underlying application. The Agency will release the drug product when and if FDA approves the underlying NDA, ANDA, or BLA within 6 months and the conditions of the PLAIR are otherwise met. A PLAIR can only be submitted for products in final packaged form, or for products that require minimal processing, such as final packaging and/or labeling.

The draft guidance sets forth in detail what must be submitted in such a request. Importantly, it does require the applicant to certify that the product will:

Remain at the facility where the processing occurred or be transferred to a single site consisting of a warehouse or a distribution facility controlled by or under contract with the applicant; Remain under quarantine pending final approval of the application; and Remain subject to the terms and conditions of the U.S. Customs and Border Protection (CBP) entry bond that covers the specific shipment. The PLAIR should be submitted no sooner than sixty (60) days prior to user fee goal date for the application. PLAIR requests are to be submitted by email only in PDF format. The amount of the product to be imported must be...