Want Faster FDA Release For Pharmaceutical Imports? Here's How.

By Elizabeth Lomax, president and principal consultant, Lomax Associates, Inc.

For pharmaceutical imports, U.S. Customs and Border Protection (CBP) import requirements are straightforward. The same rules apply to all imported articles, including drugs. On the other hand, FDA import requirements can be complex and not easy to understand. Only a few pathways are available for importing drugs, especially when they have not yet been approved. Even a small error can cause the FDA to put the import on review or hold. As a pharmaceutical importer, it is important to understand precisely when and how approved drugs, clinical supplies, and R&D materials may be imported. And you need to know what to do to increase the probability that your shipment will be released quickly.

When drugs are imported into the U.S., the shipment must be reviewed and released by FDA as well as CBP. The review is based on the documents the importer submits at the time of entry as well as the data provided in what is called the “FDA message set.” The message set provides FDA with the information it needs to ensure the import adheres to the requirements of an available import pathway. For clinical supplies, that means the drug must be covered by a valid IND that lists the foreign manufacturers for both the API and drug product. To show compliance, the message set must contain the IND number, a description of the product, and the name, address, and FDA registration number of the manufacturer(s), shipper, importer, and the delivery party. The message set must also include the FDA product code (a five- to seven-digit alphanumeric code describing the product) and a code indicating the intended use of the drug is investigational use.

All this information is reviewed by FDA’s PREDICT system, which stands for Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting. PREDICT checks the submitted message set information against FDA’s own data to verify that the IND is valid and covers the imported drug, that the drug was manufactured by the same entity listed in the IND, and that the parties involved are FDA registered. It also looks at the compliance history of the importer and the manufacturer to determine whether any issues may warrant further review or even exclusion of the drug due to safety concerns or other risk factors.

When PREDICT is able to verify the message set data, the importer receives a “may proceed” message and the drug is cleared for delivery to the importer. Submission of a complete and accurate message set is the key to allowing FDA’s system to issue a fast, automated “may proceed.” When data is incomplete or unclear, review shifts to an FDA compliance officer, resulting in a delay or even detention of the goods. For example, a mismatch between the manufacturer name and address submitted in the message set and what is shown in FDA’s own system often means PREDICT is not able to identify the entity authorized to manufacture the drug, thus preventing an automated release.

What can you do to ensure your imports are more likely to receive an automated “may proceed”?

1. Determine the regulatory requirements for your goods so you know whether submission of a message set is required. FDA applies a flag by tariff code to identify goods under its jurisdiction that may require a message set. Tariff codes flagged FD1 may or may not require data depending on their use (e.g., chemicals used for manufacturing drugs versus industrial use, which can be disclaimed), while submission of a message set is mandatory for tariff codes flagged FD2. Your customs broker can help identify the flag applicable to your goods.

2. Once you know the applicable regulatory requirements, collect the data needed for the FDA message set for your product to show it complies with the pathway requirements. Again, the pathway for importing investigational drugs requires a valid IND as well as the other information described above. There are other ways to import clinical drugs, but they are limited. Having a valid IND is the most commonly used and most efficient pathway.

3. Provide the foreign supplier with basic instructions regarding what FDA information to include on the commercial or pro forma invoice required for shipping. The supplier should clearly identify the manufacturer name, address, and FDA registration number (if different from the shipper), state the country of origin and IND number, and provide a brief end use statement such as “for investigational use.” The product description used should be consistent with the IND so the FDA can easily verify the drug is the subject of the IND.

4. Draft an end use letter to support the intended use code for investigational use. The letter should be prepared by the importer (not the foreign supplier) on company letterhead, clearly identify the product as shown in the IND, provide a reference to the shipment (e.g., an invoice number, air waybill number, or forwarder job number), and briefly state how the drug will be used. For clinical drugs, a statement such as “this drug is being imported under IND 12345 for further packaging and labeling for investigational use” is sufficient. You do not need to reiterate manufacturer information or state the quantity or batch/lot numbers if this information is already on the invoice.

5. Review data and documents to make sure they are accurate. This ensures the customs broker will pull the correct information from the documents for the FDA message set. The best practice is to provide your customs broker with all the necessary data via a separate email. This prevents them from guessing or having to search for it. You know your product the best and are the most well equipped to determine the right data. If you leave it to the customs broker, the risk is high they will get it wrong, which could knock the import out of the PREDICT automated review process and send it to a compliance officer, which will cause delays.

One last tip. Now that you have expended all that effort to gather the required regulatory information, maintain the data in a trade master database. The database could be in an ERP or automated global trade management system or just in an Excel spreadsheet. A trade master database becomes your single source of truth for data needed for frequently imported materials and provides an easy way to retrieve data for future shipments. Using verified information from your database will ensure consistency and compliance of your FDA message sets.

Being proactive can go a long way toward ensuring your clinical supply chain flows smoothly and trials commence on time. All it takes is a little up-front effort to understand the FDA’s import requirements for investigational drug and gather the data to show compliance with this import pathway.

About The Author:

Elizabeth Lomax has over 25 years of experience in the trade compliance field. She is the founder and president of Lomax Associates, Inc., a boutique trade consulting practice focusing on the pharmaceutical and biotech industries. Elizabeth’s other experience includes serving as head of global trade compliance for Novartis Pharma AG in Basel, Switzerland. Prior to the global role, Elizabeth was responsible for trade compliance for Novartis’ U.S. pharmaceuticals business located in New Jersey. Elizabeth also worked in the customs and trade compliance group at Ernst & Young in New York and in the international trade practice of the law firm of Katten Muchin Zavis in Chicago.

Elizabeth is a licensed customs broker and holds a Certificate of Purchasing and Inventory Management (CPIM) from APICS. You can reach her via email at beth@lomaxassociates.com.