FDA drug company inspections drop amid pandemic: report

FDA drug company inspections drop amid pandemic: report
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The number of drug company inspections conducted by the Food and Drug Administration (FDA) have dropped significantly due to the pandemic, resulting in a delay of new drug approvals.

The New York Times reports that the FDA conducted 52 drug company inspections between March and October last year, a sharp drop from the 400 inspections that were conducted in 2019 between the same months.

Not only have drug company inspections dropped, but the Times notes that travel restrictions have also hindered the FDA’s ability to inspect imported medicines, which account for 60 percent of drugs in the U.S.


Mary Denigan-Macauley, director of healthcare at the Government Accountability Office (GAO), told the Times that any backlog or drop in inceptions is cause for concern.

“Regardless of where drugs are manufactured, domestically or overseas, the F.D.A. has the responsibility to ensure they are effective and safe,” Denigan-Macauley said.

FDA officials told the newspaper that inspections had been limited in order to protect FDA employees, saying the agency was abiding by guidelines set by the Centers for Disease Control and Prevention which stated that federal employees should be discouraged from travelling during the pandemic.

The FDA officials denied that the drop in inspections was slowing down drug approvals, but the Times reported that several drug companies like Spectrum Pharmaceuticals, Biocon Biologics and Bristol Myers Squibb have noted the FDA's deferred actions.

In a statement to The Hill, an FDA representative said the agency was "committed" to overseeing the "effectiveness and quality of FDA-regulated products."

"During this worldwide public health emergency, in situations where physical inspections are not feasible due to travel and quarantine restrictions, the agency continues to be successful in its oversight of regulated industry and in making regulatory decisions by using additional tools such as remote interactive evaluations, record requests, and leveraging information from trusted regulatory partners," the FDA representative added.


According to Denigan-Macauley, the FDA has postponed over a thousand surveillance inspections, which are meant to ensure companies are abiding by good manufacturing practices.

“Drugs that are waiting for pre-approval inspections will also have a backlog,” Denigan-Macauley told the newspaper.

Denigan-Macauley is scheduled to testify before the House Appropriations subcommittee on Tuesday to speak on the issue of the FDA's inspection backlog.