Crossing U.S. Borders: Facilitating the Clearance of Critical Healthcare Shipments
Healthcare supply chains are becoming increasingly global and complex. Biopharma products are often manufactured in one part of the world and sold in another, while clinical trials are conducted in remote populations with limited access to medicine. As a result, healthcare shipments have to cross borders and even continents for package contents to reach final patients.
In the United States, the Food and Drug Administration’s (FDA’s) mission is to protect public health by controlling products manufactured domestically and by regulating the entry of various goods into the country.
US FDA import operations volume is measured by the number of import line items rather than by the number of entries or shipments. Each shipment arriving at the US border contains at least one import line, the number of lines being determined by the nature and origin of commodities.
In 2014, the FDA reviewed over 32 million import lines overall within its 16 import districts, up from 9 million lines in 2003.
FDA regulated commodities are classified by the federal agency in six categories, namely human foods, animal drugs and feed, cosmetics, human drugs, biologics, and devices. This last category includes heart valves and knee prostheses, but also simple toothbrushes, dental crowns, blood pressure monitors, or X-ray systems for instance.
- The FDA import commodity mix has been changing over the years, as the importance of human food import lines in the portfolio of US imports decreased from 64% in 2003 to 37% in 2014.
- The share of human biopharma import lines remained constant at around 2% in the same timeframe.
- In contrast, the relative importance of devices increased tremendously from 24% in 2003 to 51% in 2014, partially driven by regulatory changes, such as data submission rules for medical device kits.
FedEx Express international shipments are reviewed by the FDA at six US airport clearance locations.
FedEx Express receives about 10% of total FDA import shipments each year, confirming the major role played by FedEx in global trade.
Compliance with export/import regulations is key for obtaining timely clearance from regulatory agencies and for shipments to cross borders without delays. The FedEx Regulatory Affairs and Trade Compliance team provides complimentary import regulatory knowledge and expertise to facilitate proper and expeditious clearance of safe healthcare shipments.