Covid-19 testing: Got swabs?
I have been retired for 2 years from a long career in bioinformatics at a National Laboratory and was enjoying doing independent consulting and management coaching when the pandemic started. About the time that SF went into lockdown in mid-March, a friend in China asked for help getting some Covid-19 testing supplies into the American market (as the outbreak centered in Wuhan was by then hammered into submission by an extremely vigorous lockdown for 2 months.)
This opportunity gave my wife and me a new challenge during what has turned out to be a very strange year. It also let me learn a lot about various aspects of the Covid-19 testing supply chain. Here are a few observations:
Actions this spring by a raft of shady “brokers” and outright scammers claiming to have scarce PPE (masks, gloves, gowns, sanitizer, etc.) and testing supplies (nasopharyngeal swabs and collection tubes, viral transfer media, etc.) caused US medical supply distributors to be extremely wary of anybody claiming to be importing supplies from China.
US medical supply distributors invariably wanted to deal in “landed goods” only, to avoid the risks and hassles of directly importing goods.
Pandemic working conditions have enabled US distributors to set up very efficient screening firewalls. People now working from home are inaccessible via their office phone and operators often point only to generic support email addresses (or web response forms that never once have been answered.)
Many US medical supply distributors indicate on their websites if products are backordered and estimates of when they will be able to ship. Nasopharyngeal swabs and 10mL collection tubes, products my friend’s company in China manufactures, are frequently shown with long backorders (8+ weeks for US-made swabs are common, and some 10mL tubes in early October 2020 showed a backlog as far as the end of January 2021.) Interestingly, when I have been able to coax a response from companies showing long backlogs, the response has invariably been “we are not currently looking for new suppliers.” While this is understandable in cases where a distributor has a single supplier for such products (and fears upsetting that relationship), it is puzzling in other cases where multiple suppliers for one product are all backordered.
FDA regulations apply to importing and marketing all medical supply products. We learned to navigate a thicket of rules involving registering foreign manufactures, foreign exporters, and US-based initial importers (necessary in order to offer “landed goods” so that US distributors could be completely free of any importing concerns.) Picking correct FDA product codes (which affect import duties as well as regulatory status) is a black art. (Using the FDA’s database, we have seen ~10 different product codes used for viral transfer media.)
We helped the company to apply for an Emergency Use Authorization (EUA) from the FDA for a Covid-19 rapid antibody test in early May. The FDA has had over 2,400 EUA applications (for Covid-19 PCR, antibody, and antigen tests) since March. Rapid antibody tests are their lowest priority; after 5 months, we are still awaiting a decision (along with ~100+ other rapid antibody tests.) As of October 16, the FDA has 150 rapid antibody tests on their “Do Not Distribute” list. Only 16 Lateral Flow rapid antibody tests have received EUA to date. For comparison, 186 Covid-19 PCR higher-priority tests have received EUA. Regulatory processes at the FDA are thorough and therefore do not scale easily. (The FDA to their credit has done extensive hiring and reassignment, but their unprecedented backlog remains enormous.)
Logistics of moving goods via air, sea, and ground are a complex domain with an entirely separate lexicon of acronyms. If you don’t know your FOB from your DAP or DDP, you don’t know INCOTERMS.
As a rank amateur I definitely have gained immense respect for the professionals involved in all parts of the global medical supply chain. Whatever success I had in the past obtaining government funding for biodefense projects has translated poorly into marketing disposable medical devices! With luck, the slow dance with a major US medical supply distributor will successfully conclude at some point before the year ends. I am less sanguine about the FDA providing an EUA decision by then, but who knows?
Thanks for reading, and if you know any end-users who need swabs and collection tubes, point them my way please. Keep wearing your masks and stay safe!
(Tom Slezak led a pathogen bioinformatics team at LLNL for many years. He now provides independent consulting and advising services to a range of biotech companies and is attempting to help a foreign manufacturer of disposable Covid-19 testing supplies to enter the US market.)