Pharmaceutical Drugs and the Unsettling Truths About Where They Came From

Did you know that more than 50 percent of manufacturers who supply America with pharmaceutical drugs are based overseas?

Fret not. By law, the bureaucrats at the U.S. Food and Drug Administration (FDA) supervise the manufacture of all pharmaceutical drugs marketed in the United States…regardless of where they are produced.

But perhaps you should worry. This is at least according to a new report the U.S. Government Accountability Office (GAO) published this month. 

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“While domestic inspections have almost always been unannounced, FDA’s practice of generally preannouncing foreign inspections up to 12 weeks in advance may have given establishments the opportunity to fix problems before the inspection,” the GAO staff members wrote.

“As a result, investigators may be less likely to see the true day-to-day operating environment of foreign establishments as compared to domestic. Further, the FDA has relied on translators provided by the foreign establishments being inspected, which investigators noted can raise questions about the accuracy of information FDA investigators collect.”

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That report also blames globalization and COVID-19. These two factors complicated the FDA’s oversight of more than 4,800 foreign manufacturers.

The FDA inspected a relatively small number of foreign pharmaceutical manufacturing establishments in 1997. The agency significantly increased these numbers over the next two decades, with a peak in fiscal year 2016. 

Beginning in 2020, the FDA postponed most inspections because of the pandemic. During that time, the agency relied on inspections conducted by foreign regulators.

“The postponement of inspections led to a backlog of establishments never inspected or not inspected by FDA within five years—categories for which FDA considers inspections mandatory,” the GAO report said.

All of this begs the following question:

Americans rely on pharmaceuticals manufactured in other countries. Some, like China, are hostile to the United States. Isn’t that a national security risk?

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Three years ago, U.S. Republican Sen. Marsha Blackburn of Tennessee and U.S. Democratic Sen. Bob Menendez of New Jersey introduced the Securing America’s Medicine Cabinet (SAM-C) Act.

The number of Chinese facilities who manufacture pharmaceuticals for Americans had more than doubled since 2010, said Blackburn at the time.

The SAM-C Act would have encouraged pharmaceutical drug manufacturers to bring drug manufacturing back to the United States. In this country, ingredients and processes are more easily verified.

In three years, however, that bill appears to have gone nowhere.

Special thanks to Warhammer’s Wife proofreading this story before publication to make certain there were no misspellings, grammatical errors or other embarrassing mistakes and/or typos. Follow Warhammer on Twitter @Real_Warhammer