Virus forces FDA to curtail drug company inspections

Backlog may delay drug approvals, could lead to medicine shortages.

The COVID-19 pandemic has forced the Food and Drug Administration to postpone hundreds of drug company inspections, creating an enormous backlog that is delaying new drug approvals and leading the industry to warn of impending shortages of existing medicines.

What’s happening

Pandemic-related travel restrictions and safety concerns have also hampered the FDA’S ability to ensure the safety of the ever-increasing number of imported medicines, which make up more than 60% of the drugs sold in the United States.

“Regardless of where drugs are manufactured, domestically or overseas, the FDA has the responsibility to ensure they are effective and safe,” said Mary Denigan-macauley, director of health care, public health and private markets for the Government Accountability Office, a congressional watchdog agency. “Any drop in inspections, or backlog, is concerning.”

What the data shows

The numbers show a steep decline. The FDA conducted 52 inspections of domestic pharmaceutical plants between March 2020, when the pandemic took hold in the U.S., and Oct. 1, compared with 400 during the same months in 2019, according to the GAO. Inspections of foreign manufacturing facilities have been at a virtual standstill for months.

In an interview, FDA officials said they sharply curtailed the inspections to protect their investigators, following guidelines from the Centers for Disease Control and Prevention, which discouraged federal employees from travel during the pandemic.

But some people in both industry and public health communities say that federal drug inspections are essential, and that the agency should bypass travel restrictions by taking precautions.

“I think they can and they should,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group, a nonprofit advocacy organization.

Denigan-macauley said the FDA has postponed more than 1,000 surveillance inspections — the routine visits that the agency conducts to check for adherence to good manufacturing practices.

FDA officials denied the dramatic drop in inspections has slowed drug approvals. But a number of drug companies, including Spectrum Pharmaceuticals, Biocon Biologics and Bristol Myers Squibb, has issued statements noting deferred FDA action because of the agency’s inability to conduct inspections.

What might be at risk

In October, Spectrum announced the FDA had deferred action on its application for Rolontis, a treatment for cancer patients who have a very low number of certain white blood cells, because it could not inspect the manufacturing plant the company uses in South Korea.

In late December, Biocon Biologics notified shareholders the FDA deferred action on its joint application with Mylan for a proposed biosimilar to Avastin, a cancer drug.

FDA VIA NEW YORK TIMES The FDA conducted 52 inspections of domestic pharmaceutical plants between March 2020 and Oct. 1, compared with 400 during the same months in 2019, according to reports.