United States: FDA's Draft Guidance For Industry On Pre-Launch Activities Importation Requests: Dead On Arrival?

On July 25, 2013, the Food and Drug Administration ("FDA" or "the Agency") published a Draft Guidance for Industry entitled "Pre-Launch Activities Importation Requests", or "PLAIR". The draft guidance describes FDA policy on requests for importation of unapproved finished dosage form drug products by an applicant preparing for market launch pursuant to a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 The draft guidance describes the procedure for making requests for importation prior to approval, as well as the factors FDA will look to in deciding whether to grant such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The draft guidance sets forth in detail what must be submitted in such a request.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

Once submitted, the Agency will review the PLAIR request and determine whether the foreign manufacturing facility has a satisfactory inspection history and is in substantial compliance with current Good Manufacturing Practice. If the PLAIR request is granted, the Agency will notify the applicant by email. The applicant will then have six (6) months from initial shipment date to market the product. FDA will release it from detention upon approval of the NDA, ANDA or BLA. If the application is not approved in that period, FDA will refuse admission and the applicant will have sixty (60) days to export or destroy the product.

The draft guidance, if implemented, will certainly make it much easier for foreign manufacturer product to put on the market after approval, which has been a problem from time to time, as until now, the Agency permitted importation solely upon case-by case basis that led to problems. So it is certainly a welcome program to the industry. Whether it can be implemented, however, is in question.

On the same day that the Agency published notice about the guidance in the Federal Register, the D.C. Court handed down its decision in Cook v. FDA, __ F.3d __ (Civil No. 1:11-cv-002891 (D.C. Cir. 2013). That case had to do with a request by prisoners on death row to enjoin FDA from allowing the importation of unapproved (and, hence, misbranded) drugs used in lethal injection protocols. FDA in 2011 had issued a policy statement that it would defer to other law enforcement agencies and "would exercise its enforcement discretion not to review shipments of those products and allow it through CBP procedures." Essentially, the Court held that Section 381 of the Federal Food Drug and Cosmetic required that FDA "shall" refuse admission to unapproved drugs, leaving it no discretion to allow importation, and distinguishing the Heckler v. Chaney decision (470 U.S. 821, 1985), which FDA has historically relied upon on the basis of whether it can exercise discretion in its enforcement authority. The Court held that:

We identify these oases of possible agency discretion not to suggest they are beyond judicial review, a question not before us, but rather to delineate the bounds of our interpretation. We do not say the FDA must sample and examine every article under its jurisdiction that is offered for import but only that it must sample and examine drugs "manufactured, [etc.,]" in an unregistered establishment. Id. Nor do we say the FDA must find any type of drug "appears" to violate a substantive prohibition of the FDCA but only that, having found a drug apparently violates the Act, the FDA must "refuse[] [it] admission."

and further that:

In sum, we hold 21 U.S.C. § 381(a) requires the FDA to (1) sample "any drugs" that have been "manufactured, prepared, propagated, compounded, or processed" in an unregistered establishment and (2) examine the samples and determine whether any "appears" to violate the prohibits listed in § 381(a)(1)-(4). If, "from the examination of such samples or otherwise," the FDA finds an apparent violation of the Act, then it must (3) "refuse[] admission" to the prohibited drug.

All, however, may not be lost as the Court opined that the reconditioning exception may allow the Agency to permit import of unapproved drugs. As stated:

DThe plaintiffs further argue, and again we agree, that reading "shall be refused admission" as mandatory gives meaning to the exception to that command, "except as provided in subsection (b)." That subsection provides "[i]f it appears to the [FDA] that ... an article ... can, by relabeling or other action, be brought into compliance," then "final determination as to admission of such article may be deferred" while the owner posts a bond and takes remedial action.

In addition, the Court emphasized that the foreign manufacturer was "unregistered", which would not be the case with PLAIR requests.

It may be unlikely that any party would challenge FDA's PLAIR guidance. So, manufacturers may have a tool that allows them to get new products about to be approved made outside the U.S. in the pipeline sooner than under current practice. 

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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