Post by Nadica (She/Her) on Sept 6, 2024 4:41:30 GMT
COVID Delays Leave Nearly 2,000 Drug Plants Behind on Inspections: Report - Published Sept 5, 2024
Nearly 2,000 drug plants have still not been inspected since the COVID-19 pandemic halted global factory checks, an investigation by The Associated Press (AP) found.
The AP reported on Thursday that Food and Drug Administration (FDA) agents have not returned to about 2,000 drug manufacturing companies to conduct safety and quality inspections since before May 2019, according to FDA data obtained and analyzed by the AP.
The drug firms overdue for inspections make up about 42 percent of the 4,700 plants registered to manufacture drugs for the United States, according to the AP's findings.
These plants make hundreds of medicines, including antibiotics, blood thinners and cancer drugs, used by millions of Americans, and if these plants are not inspected, it increases the risks of contamination and other issues.
While most of the overdue plants are in the U.S., over 340 are in India and China, which together are the largest source of drug ingredients used to make low-cost prescription drugs in the U.S.
Factories that haven't been inspected in five or more years are considered a significant risk by the FDA and are supposed to be prioritized for "mandatory" inspections, according to agency guidelines.
"The U.S. drug supply is the safest on the planet and no other regulator conducts more inspections than the FDA," Michael Rogers, FDA Associate Commissioner, told the AP.
In March 2020, the FDA stopped all but the most "mission critical" inspections. Later that year, the agency gradually resumed prioritized inspections, but regular international checks did not start back up until 2022.
Rogers said that the FDA has increased drug manufacturer inspections each year since 2021, prioritizing factories outside the U.S. But last year's inspections were still down nearly 40 percent from pre-pandemic levels. Before the pandemic, the agency conducted an average of around 4,300 annual inspections.
One reason for the backlog of uninspected plants is staff shortages.
"There's a significant cost to the agency associated with the loss through attrition of an experienced investigator," Rogers said. "We need to retain these people, and we are."
Drug companies began moving manufacturing overseas in the 1990s for cheaper labor and materials. The FDA didn't open its first overseas outposts until 2008, and the Government Accountability Office has flagged the agency's shortfalls overseeing the global drug supply as a "high risk" issue since 2009.
"We have to recognize that this is the world we live in and we have to adapt to it," Dr. Stephen Ostroff, former FDA chief scientist, told the AP. "That has to include being able to get into these facilities and take a look at what they're doing, particularly in India and China."
Nearly 2,000 drug plants have still not been inspected since the COVID-19 pandemic halted global factory checks, an investigation by The Associated Press (AP) found.
The AP reported on Thursday that Food and Drug Administration (FDA) agents have not returned to about 2,000 drug manufacturing companies to conduct safety and quality inspections since before May 2019, according to FDA data obtained and analyzed by the AP.
The drug firms overdue for inspections make up about 42 percent of the 4,700 plants registered to manufacture drugs for the United States, according to the AP's findings.
These plants make hundreds of medicines, including antibiotics, blood thinners and cancer drugs, used by millions of Americans, and if these plants are not inspected, it increases the risks of contamination and other issues.
While most of the overdue plants are in the U.S., over 340 are in India and China, which together are the largest source of drug ingredients used to make low-cost prescription drugs in the U.S.
Factories that haven't been inspected in five or more years are considered a significant risk by the FDA and are supposed to be prioritized for "mandatory" inspections, according to agency guidelines.
"The U.S. drug supply is the safest on the planet and no other regulator conducts more inspections than the FDA," Michael Rogers, FDA Associate Commissioner, told the AP.
In March 2020, the FDA stopped all but the most "mission critical" inspections. Later that year, the agency gradually resumed prioritized inspections, but regular international checks did not start back up until 2022.
Rogers said that the FDA has increased drug manufacturer inspections each year since 2021, prioritizing factories outside the U.S. But last year's inspections were still down nearly 40 percent from pre-pandemic levels. Before the pandemic, the agency conducted an average of around 4,300 annual inspections.
One reason for the backlog of uninspected plants is staff shortages.
"There's a significant cost to the agency associated with the loss through attrition of an experienced investigator," Rogers said. "We need to retain these people, and we are."
Drug companies began moving manufacturing overseas in the 1990s for cheaper labor and materials. The FDA didn't open its first overseas outposts until 2008, and the Government Accountability Office has flagged the agency's shortfalls overseeing the global drug supply as a "high risk" issue since 2009.
"We have to recognize that this is the world we live in and we have to adapt to it," Dr. Stephen Ostroff, former FDA chief scientist, told the AP. "That has to include being able to get into these facilities and take a look at what they're doing, particularly in India and China."