Are FDA Regulations Delaying the Delivery of Protective Equipment to the US?

Registered nurse Angelo Daulat at Kaiser Permanente in Richmond on March 19, 2020, where patients with respiratory symptoms were being triaged. (Beth LaBerge/KQED)

Back in January, Jiayue He’s father in China asked her to mail him some masks. By the time they reached him, three or four weeks later, he didn’t need them anymore. Now, he's mailing them to other family members in Toronto.

Jiayue He, who also goes by Jenny, is the co-founder of Ergeon, a tech-enabled home improvement company in Palo Alto. She spent the first 10 years of her life in China and has family in Wuhan, where the coronavirus is believed to have started.

After living in England and Canada, Jenny came to the U.S. in 2004 to earn her doctorate in computer science. She went on to work at McKinsey & Company with industrial conglomerates on issues related to the global supply chain, and became familiar with the ins and outs of moving goods internationally.

Jenny said that while she was initially worried about her family in China, now they're worried about her, as the U.S. has quickly become the epicenter of the outbreak.

“They're very nervously watching the death figures in the U.S., and they've been telling me to not go outside — at all,” she said.

When Jenny heard that a friend had sourced 20 million N95 masks from China, she thought, “Gosh, maybe I should do something.”

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She sent a note to her dad, who runs a company that helps process industrial waste. Since he services factories in China, Jenny thought he might know where to find masks and other personal protective equipment likes gloves.

On March 21, Jenny’s dad told her he had found suppliers for masks and gowns and test kits.

“How much are you looking for?” he asked.

But there was one major catch: The equipment her father found was not all certified by the U.S. Food and Drug Administration.

Because of this, it would be difficult to export to the U.S. However, some of the goods from China were CE certified, meaning they met the standards of the European Economic Area, and could be sold there. Jenny noted that the CE certification takes around 10 days, while FDA certification can take closer to nine months.

So Jenny and her husband, John Craig, decided to do something. Last week, they started a petition on Change.org, asking the FDA to relax its regulations on imports.

"The U.S. federal government should allow for PPE [personal protective equipment], diagnostic tests and ventilators that have been certified by other reputable bodies besides the FDA to be easily imported and used," the petition states.

“What I’m proposing is very similar to what the Chinese government actually did," Craig said. “Because the U.S. is unfortunately a fairly decentralized health care system, and the government is not stepping up to manage the supply chain, I think it's best to kind of just throw the doors open and flood the market.”

Craig was born in Minnesota, grew up in Canada and worked in Asia for seven years for an elevator manufacturer. He said he understands why the standards for importing medical gear are stricter in normal times, but argues they should be relaxed during a pandemic.

"China relaxed their own standards, and that's part of how they got on top of things,” he said.

On Saturday, the FDA relaxed some restrictions on the import of protective gear and other devices. It is also offering manufacturers more guidance on how to get clearance for those products (this resource links to a 334 page document). But Craig said the process is still too complicated and difficult for people who simply want to help out.

As they outlined in their petition, the couple thinks the FDA should allow products with different certifications — like the CE certification — to be sold in the U.S.

As long as it's been approved by a reputable body, Craig said, companies and residents in the U.S. should be able to import them, especially when “it looks like people are literally gonna die because we don't have enough stuff.”

California Gov. Gavin Newsom speaks during a press conference at the Bloom Energy Sunnyvale campus on March 28, 2020. Bloom Energy is a fuel cell generator company that has switched over to refurbishing ventilators as an increasing number of patients experience respiratory issues as a result of COVID-19. (Beth LaBerge/KQED)

California Gov. Gavin Newsom said the state wants to work with the FDA to loosen some standards. For example, California has 21 million N95 masks, most of which have expired. He’s working to get the federal agency’s approval to use them.

FDA Commissioner Stephen M. Hahn said Saturday that the agency is partnering with the Federal Emergency Management Agency to address supply chain issues, “including importation of needed medical products to support the U.S. response.”

Also on Saturday, the Journal of American Medical Association (JAMA) published an editorial saying medical professionals need more protection. They also asked the medical community for ideas on how to solve this problem.

The number one suggestion was to import: “Purchase from international suppliers,” the journal wrote in its summary of responses. “China proposed as a primary market given manufacturing capacity, experience with and decline in COVID-19 incidence.”

“Loosen import regulations,” was another popular suggestion.

There are risks to this strategy. The Netherlands recalled defective masks imported from China earlier this month, while Spain and Turkey have said some testing kits from that country have proven faulty.

Craig admits that he’d have a different opinion if the U.S. was relaxing standards on drugs or internal medicine. But he says when it comes to protective gear, “We’re just staring down the gun of this tsunami of patients.”

More than a 1,000 people have signed the couple's Change.org petition. But Craig and Jenny would still like to see a simpler process and hope Congress will pass a law changing the policy for importing medical gear during major health emergencies.

Craig says it’s a question of organizational inertia as well as ego. “It's a matter of pride. Basically by doing this, you're admitting that, well, we have to go and ask for foreign help to solve the problem,” he said. “I think most politicians might have trouble doing that.”

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