by Will Kessler
The Food and Drug Administration (FDA) has inspected fewer pharmaceutical manufacturing facilities compared to before the COVID-19 pandemic, with foreign facilities, including those from China, seeing the largest decreases, according to a study released in December.
In 2022, the total number of inspections of drug manufacturing establishments by the FDA decreased by 79% for foreign and 35% for domestic facilities compared to 2019, before the COVID-19 pandemic, according to a study by Emily Cuddy, Yun Peng Lu and David B. Ridley using data acquired through Freedom of Information Act requests. Despite the drop in inspections, there was no corresponding decrease in imports or manufacturing, while resources allocated by the FDA toward inspections surged per inspection.
As of 2019, establishments responsible for manufacturing greater than two-thirds of active ingredients for pharmaceuticals sold in the U.S. were situated abroad, with India, Italy and China being the top producers, according to the study. Around half of the final drug products consumed by Americans are made by foreign producers.
The FDA halted inspections completely in China and India between April 2020 and March 2021, following the onset of the COVID-19 pandemic, according to the study. Travel restrictions due to disease mitigation efforts limited inspection activities during this period.
The decline in inspections and the use of announced visits during the COVID-19 pandemic present possible quality issues, as bad actors have in the past used the opportunity to hide such issues, according to the study. FDA official action notices at the time rose as well, also indicating possible quality issues as administrative and regulatory actions were recommended due to violations.
Judicial Watch released 58 pages of records from the FDA showing that a Pfizer study surveyed 23 people in 2021 to gauge reactions to its COVID vaccine booster before asking the FDA to approve it. READ: https://t.co/pDMBVnvbup
— Judicial Watch ⚖️ (@JudicialWatch) December 5, 2023
“The American public should rest assured that the drugs they rely on are high quality, safe and effective,” the FDA said in a statement to the Daily Caller News Foundation. “Drugs intended for the U.S. market manufactured outside the U.S. must meet the same standards as drugs made in the U.S. As drug manufacturing has globalized over the years, we have modernized our programs to help ensure that companies — regardless of where they are located — continue to meet the FDA’s strict standards for producing medicines.”
Following the start of the COVID-19 pandemic, the FDA reduced its physical inspections, resorting to inspecting drug product imports, receiving records instead of inspections and conducting remote interactive evaluations, according to the report. The FDA has sought to inspect all approximately 3,000 foreign establishments that provide drug products to the U.S. market following an incident in 2008 when an uninspected Chinese manufacturer exported adulterated heparin that caused 81 deaths in the U.S.
China is also a primary source country for fentanyl and fentanyl-related substances being trafficked directly into the U.S., even though the country has repeatedly promised to crack down on the illicit substance. Fentanyl accounted for almost 70% of the 110,000 overdose deaths in the U.S. in 2022.
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Will Kessler is a reporter at Daily Caller News Foundation.
