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Surprise!: FDA Will Expand The Use Of ‘Unannounced Inspections’ In Foreign Countries

Surprise!: FDA Will Expand The Use Of ‘Unannounced Inspections’ In Foreign Countries Surprise!: FDA Will Expand The Use Of ‘Unannounced Inspections’ In Foreign Countries

The U.S. Food and Drug Administration (FDA) announced Tuesday that it will increase unannounced inspections at foreign manufacturing plants that produce food and drugs for U.S. consumption.

The announcement expands upon an FDA pilot program which was already performing unannounced inspections in India and China, according to the statement.

“For too long, foreign companies have enjoyed a double standard—given advanced notice before facility inspections, while American manufacturers are held to rigorous standards with no such warning. That ends today,” FDA Commissioner Dr. Marty Makary said.

He teased the announcement in a Monday press opportunity in the Oval Office while attending President Donald Trump’s signing of an executive order banning gain-of-function research.

“We have had this crazy system in the United States where American pharma manufacturers in the United States are put through the wringer with inspections and the foreign sites get off easy with scheduled visits,” he said.

Along with around 12,000 domestic inspections, the FDA also conducts approximately 3,000 foreign inspections annually in over 90 countries, according to the announcement. Despite giving advanced warning, the FDA still discovers “serious deficiencies” abroad more than twice as much as it does domestically, the administration said.

The news comes despite mainstream media reports that senior FDA officials were planning on reducing inspections due to layoffs in support staff. (RELATED: RFK Jr Slashes 10,000 Jobs In First Step To Gut ‘Bureaucratic Sprawl’ At HHS)

The administration cut 170 staffers, including the entire travel operations division, anonymous federal health officials told CBS News in early April.

“As of yesterday, all front-line investigators will now be spending significant time processing their own travel and related administrative requirements, rather than spending that time in firms ensuring the American consumer is protected,” an FDA official said.

The FDA had already been going through a backlog in inspections stemming from the COVID-19 pandemic.

The administration’s hiring rate was unable to outpace losses, partly due to inspector retirements, according to a report from the Government Accountability Office (GAO).

“FDA faces significant challenges in recruiting, hiring, and retaining both domestic and foreign investigators, according to FDA documentation,” the report read.

America imports about 15 percent of the country’s total food supply from abroad, according to the FDA. Drugs, however, are a different story.

More than 60 percent of the manufacturers for drugs imported to America were located overseas in 2018, according to the GAO. The U.S. is particularly reliant on China for antibiotics. Chinese-produced active pharmaceutical ingredients are in almost 90 percent of antibiotics sold in America, according to a recent report from analytics firm Exiger.



This article was originally published at dailycaller.com

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