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COVID-19 Forces FDA to Stop Inspections in China

Quarantines related to the COVID-19 epidemic make it impossible for the FDA to conduct drug manufacturer inspections in China.
Pharmaceutical tablet manufacturing machine. Orange pills are sorted on a metal round conveyor.

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:

Will Worldwide Drug Shortages Result from Coronavirus Chaos?

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.

Learn More:

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?

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About the Author
Terry Graedon, PhD, is a medical anthropologist and co-host of The People’s Pharmacy radio show, co-author of The People’s Pharmacy syndicated newspaper columns and numerous books, and co-founder of The People’s Pharmacy website. Terry taught in the Duke University School of Nursing and was an adjunct assistant professor in the Department of Anthropology. She is a Fellow of the Society of Applied Anthropology. Terry is one of the country's leading authorities on the science behind folk remedies. .
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This is the primary reason we should’ve kept our own manufacturing capabilities within our own borders.

Your article leaves the question unanswered: Why does the FDA now have too few personnel to conduct the necessary multiple inspections in China? The headline says inspections are to stop. So are you saying that the FDA had the inspectors, but now does not?

Many pharmaceutical manufacturers in China already flat out refuse FDA Inspections. Doesn’t stop the U.S. pharmacies from buying and stocking them. Price/Profit trumps quality and safety.

I think the issue of our medications being manufactured in China is much more of a threat than the coronavirus. And now we can’t even do inspections? I think we need to start manufacturing all drugs in the U.S. Wonder how fast that could happen?

Why does the U.S. outsource pharmaceuticals?? It would seem to me that it would be better for all of U.S. citizens to not be relying on China to make our meds.

It is shameful that the pharmaceutical industry and the U.S. government allowed the health of Americans to be put in jeopardy by outsourcing life-saving medications and supplies to China.

On a related topic, should I be worried about taking glaucoma generic eye drop from Bangalore, India?

The drug shortage is already here. Neither Walgreens nor Walmart can fill my blood pressure prescription for Valsartan due to the drug being “back ordered at the factory.” The United States has allowed its population to be put at great risk by allowing Big Pharma to insist on getting our drugs as cheaply as possible in foreign, often third-world countries with repeated very poor safety records. We need to make medications under hygienic, safe conditions here in the United States and secure our own supply of medications for our population. Depending on foreign countries, and the goodwill of their governments, for our medicine supply is quite foolish.

Recently, I lost count of the recalls on various blood pressure medications made abroad due to adulteration with known carcinogens. Inability to provide medications to our population makes us quite vulnerable when world-wide calamities or conflicts with other governments occur.

I personally think that we should have never used China as a manufacturer in the first place. But lobbyists and greed in Congress pushed this through. There are friendlier nations as well as our own country that can do what China does.

I’ve read Eban’s “Bottle of Lies” book describing the problems with drugs manufactured overseas and why it is difficult for the FDA to monitor and inspect these manufacturers. The solution, in my opinion, is to STOP trying to monitor other governments’ products, processes and oversight, and START sampling all drugs and drug ingredients shipped into U.S. ports.

Construct at least one special analysis lab on each coast of the U.S. through which all imported drugs/ingredients must be received. Inspect a sample of all such shipments. REJECT any shipments with high impurities, toxic ingredients, and out of range strength. Once enough inferior shipments are sent back to country of origin, the country will get the message (and not get their funds). The FDA can always offer consulting to improve processes and correct deficiencies. To expect the FDA to be the world’s on-site drug police is unrealistic.

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