WASHINGTON, DC – A news report posted on nytimes.com reports that the U.S. Food and Drug Administration has postponed conducting hundreds of drug company inspections due to the coronavirus. The FDA states that the agency is trying to guard its employees against the coronavirus. However, critics state the FDA’s inspectors are “essential workers” and must do their jobs. The FDA’s partial shutdown has stalled a substantial number of new drug applications.
In 2019, the FDA administered 1,671 foreign and domestic drug manufacturing facility inspections. The number of inspections in 2020 fell to 742. The U.S. Food and Drug Administration’s postponement of hundreds of drug company inspections has created a tremendous backlog. The backlog is delaying approvals on new drugs, which could cause drug shortages.
Coronavirus-related travel restrictions, along with safety concerns, have also hindered the FDA’s capacity to assure the safety of the imported medicines, which account for approximately 60 percent of the medications marketed in the United States.
The number of FDA inspections declined sharply in 2020. According to the news report, the FDA only conducted 52 domestic pharmaceutical plant inspections between March 2020 and October 1, 2020. In 2019, the FDA conducted 400 domestic inspections during the same time frame, while foreign manufacturing facility inspections have been at a standstill for several months.
FDA officials stated the halting of inspections was to keep their investigators safe from the coronavirus, and the agency was following Centers for Disease Control and Prevention guidelines, which warned against federal employee travel during the coronavirus pandemic. However, public health advocates stated that the FDA drug inspections are essential, and the FDA should circumvent coronavirus travel restrictions.
According to Dr. Michael Carome, the Public Citizen’s Health Research Group’s director, the inspectors can travel safely by wearing gowns, N95s masks, and gloves. Also, the inspectors could be vaccinated. The Public Citizen’s Health Research Group is a nonprofit advocacy organization.
The news article states that FDA officials disputed that the dramatic drop in manufacturing plant inspections has stalled drug approvals. However, several drug companies have issued statements regarding delayed FDA action due to the agency’s incapacity to conduct inspections. Last October, Spectrum stated that the FDA deferred its application for Rolontis. Rolontis is a treatment for cancer patients suffering from very low numbers of white blood cells.
Some safety advocates have proposed that the FDA uses virtual video inspection technology to allow the FDA inspectors to view inside the facilities. The FDA stated that it is evaluating the idea and has used virtual sessions for viewing a manufacturer’s documents.
FDA drug company inspections involve reviewing a company’s internal records, checking how supplies are managed, inspecting the building, determining if the company complies with good manufacturing practices, and reviewing quality controls. The FDA carries out three types of inspections:
- Pre-approval inspections (applications for a new drug);
- Routine surveillance inspections performed once every five years; and
- Problem follow-ups.
Although many public health experts are bothered by the large drop in inspections, most think virtual inspections would not be a safe substitute for in-person inspections. The FDA stated that a majority of the foreign inspections would continue to be postponed.
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