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.
“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.
The FDA inspects when an overseas factory seeks approval to supply drugs or drug ingredients for the American market. Factories are also subject to periodic “surveillance” inspections to gauge whether they are meeting quality standards. When the agency becomes aware of a possible safety problem with a drug or manufacturing process the FDA conducts “for cause” inspections.
Hahn said all inspections scheduled for February were postponed or the agency used “other information to inform decisions allowing the products to enter our U.S. market.” He said 90% of those inspections were routine surveillance. The agency also delayed this month’s scheduled for-cause inspections after analyzing information for each factory in question. Most surveillance inspections scheduled for March at drug and medical device factories already have been postponed, he said. The agency did not address inspections in January.
“We will continue to closely monitor the situation in China so that as the situation improves, we will be prepared to resume routine inspections,” he said.
The FDA has faced questions from lawmakers about how the coronavirus outbreak has affected the agency’s oversight of drug and device factories. And last December, before the outbreak was known, a Government Accountability Office report revealed the number of inspections at overseas factories dropped 10% from 2016 to 2018 and found “persistent challenges” such as not hiring and retaining enough inspectors.
Michael Carome is director of Public Citizen’s health research group and an expert on drug safety and FDA oversight.
“The fact that the FDA has suspended inspections is worrisome,” Carome said. “We start from a baseline position of they are not doing enough inspections in China, where the active ingredients for a lot of our drugs are made. Any further delay or suspension in their inspections makes the problem worse.”
Carome said a short suspension probably won’t make a huge difference. However, if the outbreak delays inspections for several weeks or months “that’s going to impact drug safety,” he said.
Another potential problem: The U.S. might need to navigate drug or medical product shortages if the coronavirus outbreak continues to snarl production in China, a pivotal supplier for American consumers, doctors and hospitals.
Hahn said the agency is “keenly aware” the coronavirus outbreak “will likely impact the medical product supply chain, including potential disruptions to supply or shortages of critical medical products in the U.S.”
The agency has reached out to manufacturers and shifted resources to identify potential medical product shortages. He said the agency is tracking reports of increased orders of medical devices such as masks, gloves, respirators and surgical gowns.
Howard Sklamberg, a former FDA deputy commissioner overseeing foreign inspections during the Obama administration, said the agency tries to take action to avert drug and medical device shortages. Some strategies might include finding other suppliers, possibly in another country, or accelerating approval of a drug from another manufacturer awaiting FDA review.
Some drug or device supply disruptions can be predicted, such as when a company alerts the FDA of plans to discontinue a drug or suspend production due to a manufacturing problem. Other times, the change can be sudden. In 2017, Hurricane Maria slammed Puerto Rico and shut down production at drug factories that made critical supplies such as saline solution.
“This type of thing happens more frequently than one might think,” Sklamberg said of drug shortages. “It happens when there is a weather problem. Oil spills. Or there could be a situation like a civil war,” which can disrupt production or make it impossible for inspectors to access a factory.
Even if inspectors are shut out of routine surveillance or “for-cause” checks, the FDA has other options to protect consumers from receiving tainted products. The agency can halt overseas shipments of problem drugs, devices or food through “import alerts” coordinated with customs and border enforcement officials.
Whether the coronavirus disrupts drug supplies “largely depends on how long the emergency continues and how broad the geographic area is,” said Sklamberg, now a partner in the law firm Akin Gump.
“The supply chain and the level of inventory in the US already varies a lot by drug. It’s hard to make an overall statement, other than it depends on how long this goes on.”
Tom Cosgrove, a former director of FDA’s office of manufacturing quality, said the FDA’s inspection system is very flexible.
“The issue is, how will the FDA inspection regime fare if they can’t access China?” said Cosgrove, now a partner in the law firm Covington & Burling.
If the quarantine succeeds and inspections resume “within a couple of months, I don’t think there will be a major impact on the FDA. But if it’s more than a couple months, the FDA could fall behind on its inspection program and it would take a long time to catch up.”