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Alarming Lapses in Inspection of Drugs Made in Foreign Countries

March 10, 2021 by Tom Ramstack
GAO Health Care Director Mary Denigan-Macauley, PhD.

WASHINGTON — A government report released Tuesday raised alarms about the quality of pharmaceuticals made in foreign countries but consumed by Americans.

It said the purity of the drugs is questionable because of a lack of adequate inspections by the Food and Drug Administration of the manufacturing plants that produce them.

“The outbreak of COVID-19 has called greater attention to the United States’ reliance on foreign drug manufacturers,” the Government Accountability Office report said. “FDA reports that 74% of establishments manufacturing active ingredients and 54% of establishments manufacturing finished drugs for the U.S. market were located overseas, as of May 2020.”

The report did not describe specific drugs that are contaminated but merely said there is potential for them to slip into U.S. markets because of scant oversight of the manufacturing processes.

The Food and Drug Administration reported doing 1,671 inspections of foreign and domestic drug manufacturing facilities in 2019.

By January of this year, “we found that the total number of FDA inspections of foreign establishments was about 60% lower in fiscal year 2020 than during each of the previous two fiscal years,” the GAO report said. “From March 2020 … through the end of the fiscal year, FDA conducted three foreign mission critical inspections—one each in Canada, Germany, and India.”

Last March, the Food and Drug Administration announced it would temporarily halt all but critical inspections to protect its employees from COVID-19.

The sharp drop in mandatory inspections has delayed new drug applications. Critics of the agency argue that Food and Drug Administration inspectors should be considered essential workers required to continue with their normal job duties.

The warnings about inspection lapses were the subject of a House Appropriations subcommittee hearing Tuesday, where lawmakers sought assurances drugs used by Americans are safe.

“The health, safety and welfare of the American people are at great peril,” said Rep. Sanford Bishop, D-Ga., who chairs the subcommittee on agriculture, rural development, Food and Drug Administration and related agencies.

He cited government reports showing that in 2016, about 1,000 of 3,000 foreign drug manufacturers had never been inspected by the Food and Drug Administration, particularly in India. Some of them lacked proper sterilization of equipment and engaged in deceit to hide their lack of professional standards, Bishop said.

He put part of the blame on different inspection procedures the FDA uses for foreign facilities.

In the United States, the inspectors usually show up unannounced to check on manufacturers’ compliance with safety standards. In foreign countries, they lack discretion for unannounced inspections.

“The majority of foreign plants receive notice of inspections as much as 12 weeks in advance,” Bishop said.

As a result, they often clean up their plants before inspectors arrive to create the appearance of health and safety compliance, he said.

Mary Denigan-Macauley, director of health care for the Government Accountability Office, blamed a lack of qualified personnel for some shortcomings in inspections.

“Something isn’t quite working and that’s what we’re trying to figure out,” Denigan-Macauley told lawmakers. “There are still vacancies year after year.”

In addition, the Food and Drug Administration lacks interpreters who understand the languages of foreign manufacturers. Denigan-Macauley said inspectors often must depend on the drug manufacturers to offer them translation services.

“If you’re relying on that establishment for the translations, that’s not acceptable,” she said.

Rep. Jeff Fortenberry, R-Neb., questioned the wisdom of allowing Chinese manufacturers to determine the quality of drugs sold in America after their government initially concealed the source and dangers of COVID-19.

“I am not very optimistic” about whether China would ensure the quality of drugs sold in the United States, he said.

He recommended that the Food and Drug Administration use its authority more often to stop foreign-made drugs of questionable quality from entering the United States.

“It’s a powerful tool and I hope it’s used well,” Fortenberry said.

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