The Food and Drug Administration has announced that it has stopped inspections in China of drug manufacturing facilities because of the COVID-19 epidemic. The FDA is, however, monitoring the drug supply chain carefully in case of shortages. We wrote earlier about the possibility that this novel coronavirus might disrupt supplies and create shortages. You can read that story here:
Is there a possibility of worldwide drug shortages? China makes key ingredients for many critical pharmaceuticals. Are we prepared for drug disruptions?
Why Does FDA Need to Do Inspections in China?
China makes both raw materials, known as active pharmaceutical ingredients or APIs for short, and finished drug products. The FDA inspects plants making pharmaceuticals destined for the US market, although it uses different rules for inspections in China compared to the US. In this country, inspectors arrive unannounced and aim to inspect manufacturing facilities every two years. In China and several other countries, inspectors must arrange their visits ahead of time. The agency does not have enough personnel to conduct multiple inspections abroad.
Will There Be Drug Shortages?
Concerns have been raised about the possibility of shortages. Erin Fox, PharmD, BCPS, FASHP, a pharmacist who has specialized in drug shortages, points out that hospitals do not stock large medication reserves. Most health systems keep only a few weeks’ supply of medicine on hand.
Such just-in-time inventory control works well under normal circumstances but not during pandemics when factories shut down and transportation is restricted. India makes roughly 40% of the generic drugs sold in the US. Many of the drug companies in India get their active pharmaceutical ingredients from China. Some experts estimate that Indian drug companies may only have a two-month supply of these APIs on hand. If there are disruptions in the pharmaceutical supply chain, Americans could quickly discover that antibiotics and other essential medicines might become scarce.
We have interviewed two authors who have written revealing books about the outsourcing of the American pharmaceutical industry. They both discuss how and why the FDA conducts inspections in China. You may wish to listen to Show 1131: Was Your Medicine Made in China? with Rosemary Gibson. The other interview was with Katherine Eban. It is Show 1169: What Are the Problems with Generic Drugs?