The U.S. relies on China for medications as production for many generic medicines are located off-shore, but the Food and Drug Administration said it does not know much more than that.
"The FDA doesn’t know whether Chinese facilities are actually producing APIs (active pharmaceutical ingredients), how much they are producing, or where the APIs they are producing are being distributed worldwide, including in the United States," said Janet Woodcock, FDA’s director of the Center for Drug Evaluation and Research, in congressional testimony. "We do not have information that would enable us to assess the resilience of the U.S. manufacturing base, should it be tested by China’s withdrawal from supplying the U.S. market."
As reported in an article by Fierce Pharma, FDA information shows that the amount of Chinese facilities licensed to produce APIs for U.S. drugs is greater than the entire European Union. But, Fierce Pharma reports, these statistics don't mean or amount to much.
In the global market, China is the largest supplier of API's, according to a CGTN article.
These APIs refer to the biologically active component of a drug product, which include tablets and capsules, according to Science Daily. While there are usually several components in the drugs, APIs represent the primary elements.
The FDA said it doesn’t have information about the volume of APIs produced in China.
More than 90% of the antibiotics, vitamin C, hydrocortisone and ibuprofen in the United States comes from pharmaceutical companies in China, according to an article in the New York Times.
Additionally, 70% of acetaminophen and 40% to 45% of heparin comes from China, said to Yanzhong Huang, a senior fellow for global health at the Council on Foreign Relations.
When inspections happen in China, they are usually known of and prepared for ahead of time. The FDA said inspections must be announced long before the inspection date through Chinese and U.S. State departments.
Even with the time to prepare, FDA officials said they have identified serious regulatory concerns.
But the FDA does not have many options when it comes to responding to the inspections and any errors or violations, according to a Forbes article.
Also, the FDA does not require or perform "release testing" on imported drugs from overseas locations, including China, even through the FDA runs six different Offices of Pharmaceutical Quality in the U.S. that have the capability to perform such tests.
"These new ways of making drugs could, with the proper strategies, revitalize pharmaceutical manufacturing in the United States," Woodstock told Congress.