Coronavirus halts FDA inspections in China, might disrupt drug supply

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The Food and Drug Administration has pulled inspectors from China amid the rapidly-spreading coronavirus and has warned Americans might face shortages of “critical medical products” if the outbreak persists.

The federal agency halted inspections of drug and device factories due to the State Department warning against travel to China. The FDA has faced Congressional scrutiny for its oversight of overseas factories following high-profile recalls of blood pressure-lowering medications and reports revealing fewer overseas inspections in recent years.

Although the coronavirus outbreak seems to put the federal agency behind schedule on routine safety and quality checks of drug and device factories, Commissioner Stephen Hahn said the agency can still monitor China-made products through testing, records requests and “import bans” that forbid products from entering the U.S.

Dr. Stephen Hahn is the new commissioner of the Food and Drug Administation.

“The robust and multi-layered compliance process at the FDA is helping to protect American patients and consumers even though we are not able to conduct inspections in China at this time,” Hahn said in a statement.

The FDA’s database of inspections, current as of Feb. 7, shows the agency has not listed any inspections of a Chinese factory since last December. Inspections in China typically slow down in January around the time of Chinese New Year, but the absence of on-site safety and quality checks will now extend into March.

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