Yesterday, Sen. Marco Rubio (R-Florida) said that 80 percent of active drug ingredients come from China.

But Rubio’s statement is false. The United States doesn’t know how many active drug ingredients come from China or where they’re distributed. Most importantly, the government doesn’t know how dependent we are on China or other countries for these products.

However, China’s increased presence in this market suggests the United States’ dependence on other countries is growing, a Food and Drug Administration (FDA) official said months ago.

What are active drug ingredients?

They’re the ingredients that make drugs work. They are substances that have a direct effect on disease prevention, treatment or the way the body works.

Active drug ingredients are used in tablets, capsules and other drug products, like injections.

In industry jargon, these are also called active pharmaceutical ingredients, or APIs.

How did Rubio’s comment come up?

Health and Human Services Secretary Alex Azar testified yesterday during a Senate appropriations subcommittee hearing on the Health and Human Services budget. But instead, much of the hearing focused on the novel coronavirus, a respiratory illness that the Centers for Disease Control and Prevention expects to spread to communities in the United States.

Rubio mentioned the statistic and later asked Azar how the US could deal with a drug shortage related to China.

Azar said: “It’s a very difficult challenge, because the supply chains with drugs, as with the rest of our economy, are very much globalized and entwined with China and elsewhere, and one can’t stand up a manufacturing facility for pharmaceuticals just overnight.”

Azar said that companies are required to report potential drug shortages and none connected to China or the coronavirus have been reported. Companies aren’t required to report potential medical device shortages, he said.

Some drug manufacturers are based in China’s Hubei province, home to Wuhan, the epicenter of the coronavirus. Azar said those companies report having large stockpiles of product available.

On Twitter, Rubio repeated his claim on how many active drug ingredients come from China, adding, “The potential for disruption from #coronavirus reminds us how dangerous it is for us to be this dependent on one country for our medicines.”

However, FDA officials have said we don’t know the extent of our reliance on China for these drug components.

If we don’t know how many active drug ingredients are from China, what do we know?

An FDA spokesperson directed us to congressional testimony from Dr. Janet Woodcock, the director of FDA’s Center for Drug Evaluation and Research. Four months ago, she said the United States “relies heavily” on other countries, including China, for drug materials and drugs themselves, creating vulnerabilities in the supply line.

Seeking cost savings and lax environmental regulations, drug production has slowly moved outside the US in recent decades – especially in the area of active drug ingredients.

Last year, only 28 percent of active drug ingredient manufacturers were in the United States. That means most were overseas, with 26 percent in the European Union, 18 percent in India and 13 percent in China, according to FDA data.

China’s role in this market is expanding. The number of registered Chinese facilities making active drug ingredients more than doubled during the last decade. According to an FDA analysis, three drugs on the World Health Organization’s list of essential medicines have API manufacturers based solely in China.

Compared to China, the United States has more than twice the number of facilities that make APIs for regulated drugs. China doesn’t have any facilities that make active drug ingredients for flu medicines, while the US has two.

Why don’t we know how many active drug ingredients from China are in American drugs?

The FDA has a list of the manufacturing facilities that make drugs for the US market, but the data is missing vital information.

Among the issues Woodcock pointed out: Companies don’t have to tell the FDA if they’re making active drug ingredients at a certain facility or how much they’re making. The FDA doesn’t know which companies supply drug manufacturers with active drug ingredients.

And disclosure rules are different for facilities that make active drug ingredients for products that can be marketed without FDA approval. Companies that supply APIs for those products don’t have to register their facility with the FDA if they send the ingredients to a manufacturer outside the United States.

Woodcock said that as a result of this missing information, the FDA “cannot determine with any precision the volume of API that China is actually producing, or the volume of APIs manufactured in China that is entering the U.S. market, either directly or indirectly by incorporation into finished dosages manufactured in China or other parts of the world.”

So, the FDA doesn’t know how dependent the United States is on APIs from China, India or other countries, Woodcock said, adding that the agency doesn’t even know how many active drug ingredients the United States produces.

The FDA also doesn’t know how many drugs produced in other countries used APIs from China.

Contact Big If True editor Mollie Bryant at 405-990-0988 or bryant@bigiftrue.org. Follow her on Facebook and Twitter.

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