This past year saw several recalls of over-the-counter eye drops and the frequency of the recalls has raised concern about the manufacturing practices of overseas plants.
A study that was recently published online in Pharmaceuticals & Medical Technology reveals that during the onset of the COVID-19 pandemic, the FDA ceased inspections of most overseas drug manufacturing plants. Even as recently as 2022, inspections of foreign plants remained well below pre-pandemic levels with a 79 percent decrease in foreign inspections and a 35 percent decline in domestic inspections compared with 2019. Despite this reduction in inspections, there was no reciprocal reduction in drug manufacturing or importation of drugs. And now, almost 4 years post-pandemic, most foreign inspections are still on hold.
Researchers of the study offer the following recommendations to Congress: prioritizing foreign inspections, increasing the investigator workforce, increasing international cooperation, spreading the drug quality assurance burden and increasing patients' awareness of drug quality.
