Covid News: Many adults in US remain unvaccinated despite warnings of new wave
The Food and Drug Administration is accelerating a wide range of facility inspections that were delayed by travel breaks after the pandemic began.
Inspections have long been a crucial tool to ensure that medicines are free of contaminants, defects in devices are repaired and the food supply is hygienic. If agency inspectors find serious problems, they usually demand improvements, but they can also seize goods or take civil or criminal action.
Typically in recent years, FDA inspected about 12,500 U.S. facilities a year, a number that has fallen by about half, to about 6,100, in 2021. Foreign inspections — the agency visits facilities making products for the U.S. market — have fallen even more precipitously , rising from more than 3,100 in the years before the pandemic to 167 in 2021.
In recent months, FDA inspections have revealed alarming issues. A consumer complaint led federal inspectors to a Family Dollar distribution center in Arkansas in January, where they found live and dead rodents “in various states of decomposition.”
A company document review revealed that 2,300 rodents had been collected since March 2021. A recall of a wide range of foods, drugs, cosmetics and dietary supplements followed.
FDA inspectors also probed Abbott Nutrition’s infant formula manufacturing facility in Sturgis, Michigan, after the company reported finding Cronobactor sakazakii bacteria during his own routine tests.
The company also issued a recall. the the survey includes five infant hospitalizations and may have contributed to two deaths.
It is estimated that 73% of facilities manufacturing active medicinal ingredients for the US market are located overseas. The Federal Accountability Office has raised concerns on the duration of inspections and vacancies among foreign inspectors.
The FDA said Friday that “mission-critical” inspections have never stopped, even as the agency halted travel to keep its workforce safe during pandemic virus surges. National inspections resumed in February after a pause during the spike in cases of the Omicron variant. The FDA planning to come back at its “normal cadence” of inspections abroad in April.
The FDA is “working as quickly and safely as possible to resume normal operation of inspections that put public health first,” spokesman Jeremy Kahn said in an email.
In the United States and abroad, the drop in inspections has been accompanied by a drop in enforcement actions, such as warning letters, injunctions and product recalls, according to to an analysis by the law firm Skadden, Arps, Slate, Meagher & Flom.
The app has also shifted focus, noted partner Jennifer Bragg, focusing more on unsubstantiated claims about testing and treating the coronavirus.
An unintended consequence of a new wave of inspections could be that companies halt production while responding to issues FDA officials uncover, exacerbated current shortage of medicine or sterile injection fluid.
It happened years ago when the agency zeroed in on overseas blood thinner makers after sterility lapses were linked to dozens of deaths in the United States, said Erin Fox, a drug shortage expert at the University of Utah.
“Are we going to have a repeat of this?” Mrs. Fox wondered. “Just quality in general is really important.”