F.D.A. has NOT inspected more than 2000 drug plants

[Melensdad]

Well this is something that all consumers should be worried about.

Non political.

Just typical for non-accountable government employees who are nearly impossible to fire.

I typically buy 'generic' brand medications like the CVS or Walgreen's version of DayQuil or their own store brand versions of Advil, but I have to admit i might be changing my buying habits.

Nearly 2,000 drug plants are overdue for FDA checks after COVID delays, AP finds

Federal regulators responsible for the safety of the U.S. drug supply are still struggling to get back to where they were in 2019, before the COVID-19 pandemic upended factory inspections in the U.S. and across the world, The Associated Press has found. An AP analysis of Food and Drug...

uk.finance.yahoo.com

FULL STORY AT LINK ABOVE ^^^​

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WASHINGTON (AP) — Federal regulators responsible for the safety of the U.S. drug supply are still struggling to get back to where they were in 2019, before the COVID-19 pandemic upended factory inspections in the U.S. and across the world, The Associated Press has found.​

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An AP analysis of Food and Drug Administration data shows that agency staffers have not returned to roughly 2,000 pharmaceutical manufacturing firms . . .​

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The firms that are overdue for safety and quality inspections represent about 42% of the 4,700 plants that are currently registered to produce drugs for the U.S. and previously underwent FDA review before May 2019, the AP found. The plants make hundreds of critical medicines, including antibiotics, blood thinners and cancer therapies.​

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Under FDA’s own guidelines, factories that haven’t been inspected in five or more years are considered a significant risk and are supposed to be prioritized for “mandatory” inspections. Most of the overdue plants are in the U.S., but more than 340 are in India and China, countries that together make up the largest source of drug ingredients used in low-cost U.S. prescriptions.​

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“Generic drugmakers are under intense pressure to cut their costs and some will do that by cutting quality,” . . . “If they’re not inspected, then we won’t know about it until — in a few tragic cases — it’s too late.”​

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Last year, tainted eyedrops from an Indian factory led to an outbreak of antibiotic-resistant bacteria that sickened more than 80 Americans, killing four of them and blinding more than a dozen others. The plant never registered with the FDA.​

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But last year’s inspection numbers were still down almost 40% from the pre-pandemic period, when the FDA averaged around 4,300 annual inspections. Rogers offered no date for when the backlog of uninspected plants might be cleared.​

 

[Melensdad]

And more:

5 takeaways from AP's report on the big backlog of uninspected drug factories

As COVID-19 swept across the globe in early 2020, the Food and Drug Administration pulled most of its safety inspectors from the field, creating a massive backlog of uninspected pharmaceutical plants in the U.S. and overseas. Nearly five years later, The Associated Press wanted to assess the...

www.yahoo.com

FULL STORY AT LINK ABOVE ^^^

5 takeaways from AP's report on the big backlog of uninspected drug factories​

Thu, September 5, 2024 at 8:16 AM CDT​

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WASHINGTON (AP) — As COVID-19 swept across the globe in early 2020, the Food and Drug Administration pulled most of its safety inspectors from the field, creating a massive backlog of uninspected pharmaceutical plants in the U.S. and overseas.​

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Nearly five years later, The Associated Press wanted to assess the FDA's performance in catching up on inspections of factories that produce drugs used by millions of Americans.​

. . . ​

Here are five takeaways from the AP’s exclusive story:​

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The FDA hasn’t returned to roughly 2,000 drug manufacturing plants since before the pandemic​

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The overdue drug plants identified by the AP represent about 42% of the firms that are currently registered to produce drugs for the U.S. and previously underwent FDA surveillance inspections before May 2019. The plants make hundreds of critical medicines, including antibiotics, blood thinners and cancer therapies.​

​

Under FDA's own guidelines, factories that haven’t been inspected in five or more years are considered a significant risk and are supposed to be prioritized for inspection.​

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While most of the overdue plants are in the U.S., more than 340 are in India and China, the main producers of generic drug ingredients for U.S. prescriptions.​

. . .​

FDA staffers keep leaving the agency, hampering inspection efforts​

. . . ​

Vacancies persist among FDA’s workforce​

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FDA staffers are uncovering serious problems as they return to overseas plants​

. . . ​

 

[waybomb]

From experience...FDA does not inspect FDA inspected facilities.

 

[dendori]

I guess they all follow the steps from here.

 

[tommu56]

I guess they missed the The Wuhan Institute of Virology TOO!!!!!