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In the early days of the pandemic, the U.S. government turned down an offer to manufacture millions of N95 masks in America

May 10. 2020
Mike Bowen, Vice President of Prestige Ameritech, stands with a truck load of masks to be sent to MD Anderson Cancer Center. MUST CREDIT: contributed by Elizabeth Givens.
Mike Bowen, Vice President of Prestige Ameritech, stands with a truck load of masks to be sent to MD Anderson Cancer Center. MUST CREDIT: contributed by Elizabeth Givens.
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By The Washington Post · Aaron C. Davis · NATIONAL, HEALTH 

It was Jan. 22, a day after the first case of covid-19 was detected in the United States, and orders were pouring into Michael Bowen's company outside Fort Worth, some from as far away as Hong Kong.

Bowen's medical supply company, Prestige Ameritech, could ramp up production to make an additional 1.7 million N95 masks a week. He viewed the shrinking domestic production of medical masks as a national security issue, though, and he wanted to give the federal government first dibs.

"We still have four like-new N95 manufacturing lines," Bowen wrote that day in an email to top administrators in the Department of Health and Human Services. "Reactivating these machines would be very difficult and very expensive but could be achieved in a dire situation."

But communications over several days with senior agency officials - including Robert Kadlec, the assistant secretary for preparedness and emergency response - left Bowen with the clear impression that there was little immediate interest in his offer.

"I don't believe we as an government are anywhere near answering those questions for you yet," Laura Wolf, director of the agency's Division of Critical Infrastructure Protection, responded that same day.

Bowen persisted.

"We are the last major domestic mask company," he wrote on Jan. 23. "My phones are ringing now, so I don't 'need' government business. I'm just letting you know that I can help you preserve our infrastructure if things ever get really bad. I'm a patriot first, businessman second."

In the end, the government did not take Bowen up on his offer. Even today, production lines that could be making more than 7 million masks a month sit dormant.

Bowen's overture was described briefly in an 89-page whistleblower complaint filed this week by Rick Bright, former director of the Biomedical Advanced Research and Development Authority. Bright alleges he was retaliated against by Kadlec and other officials - including being reassigned to a lesser post - because he tried to "prioritize science and safety over political expediency." HHS has disputed his allegations. 

Emails show Bright pressed Kadlec and other agency leaders on the issue of mask shortages - and Bowen's proposal specifically - to no avail. On Jan. 26, Bright wrote to a deputy that Bowen's warnings "seem to be falling on deaf ears." 

That day, Bowen sent Bright a more direct warning. 

"U.S. mask supply is at imminent risk," he wrote. "Rick, I think we're in deep s---," he wrote a day later.

The story of Bowen's offer illustrates a missed opportunity in the early days of the pandemic, one laid out in Bright's whistleblower complaint, interviews with Bowen and emails provided by both men. 

Within weeks, a shortage of masks was endangering health-care workers in hard-hit areas across the country, and the Trump administration was scrambling to buy more masks - sometimes placing bulk orders with third-party distributors for many times the standard price. President Donald Trump came under pressure to use extraordinary government powers to force private industry to ramp up production.

In a statement, White House economic adviser and coronavirus task force member Peter Navarro said: "The company was just extremely difficult to work and communicate with. This was in sharp contrast to groups like the National Council of Textile Organizations and companies like Honeywell and Parkdale Mills, which have helped America very rapidly build up cost effective domestic mask capacity measuring in the hundreds of millions."

Carol Danko, an HHS spokeswoman, declined to comment on the offer by Bowen and other allegations raised in the whistleblower complaint. Wolf also declined to comment on the whistleblower complaint.

A senior U.S. government official with knowledge of the offer said Bowen, 62, has a "legitimate beef."

"He was prescient, really," the official said, speaking on the condition of anonymity to describe internal deliberations. "But the reality is [HHS] didn't have the money to do it at that time."

Another HHS official, also speaking on the condition of anonymity, said: "There is a process for putting out contracts. It wasn't as fast as anyone wanted it to be." 

- - - 

Two decades ago, the low-slung factory in Texas was part of a supply conglomerate that produced almost 9 in 10 medical and surgical masks used in the United States.

Bowen was a new product specialist at the plant back then, and he watched as industry consolidations and outsourcing shifted control of the plant from Tecnol Medical Products to Kimberly-Clark and then shuttered it altogether. In less than a decade, almost 90 percent of all U.S. mask production had moved out of the country, according to government reports at the time.

Bowen and Dan Reese, a former executive at Tecnol, went into business together in 2005 and eventually bought the plant, believing a market remained for a dedicated domestic manufacturer of protective gear.

In wake of the terrorist attacks of Sept. 11, 2001, Congress appropriated $6 billion to buy antidotes to bioweapons and the medical supplies the country would need in public health disasters. An obscure new government organization called the Biomedical Advanced Research and Development Authority, or BARDA, was among the agencies purchasing material for what would become the Strategic National Stockpile.

Bowen began studying BARDA, attending its industry conferences and searching for a way in to press his case. 

In the parlance of BARDA, Bowen was seeking a "warm base" contract. The government would pay a premium to have masks manufactured domestically, but his company would keep its extra factory lines in working order, meaning production could be ramped up in an emergency.

Bowen said he soon concluded that BARDA's focus was trained elsewhere, on billion-dollar deals to induce manufacturing of vaccines for the most exotic disasters, such as weaponized attacks with anthrax or smallpox.

Still, as Bowen moved down the supply chain, appealing directly to hospitals to buy his domestic-made masks, his sales pitch often ended with a plea to call BARDA.

Bowen often carried PowerPoint slides from a 2007 presentation by BARDA and its parent division at HHS, the Office of the Assistant Secretary for Preparedness and Response. One had a table showing that, in the event of a pandemic, the country would need 5.3 billion N95 respirator masks, 50 times more than the number in the stockpile. The presentation concluded: "Industrial surge capacity of [respiratory protection devices] will not be able to meet need and supplies will be short during a pandemic."

Bowen said he felt like a voice in the wilderness.

"The world just looked at me as a mask salesman who was saying the sky was falling," he said, "and they would say, 'Your competitors aren't saying that in China.' "

After Trump's election, Bowen hoped the new president's America-first mentality might trickle down to operations like his. He wrote a letter to Trump and addressed it to 1600 Pennsylvania Avenue: "90% of the United States protective mask supply is currently FOREIGN MADE!" it began.

"I didn't think Trump would read it, but I thought someone would and take note," Bowen said.

He also called Bright, who had been appointed to lead BARDA just before Trump took office. "In 14 years of doing this, there have been maybe four people in government who I felt like really understood this issue," Bowen said. "Rick was one of them." 

In Trump's first year, however, Bowen grew newly disillusioned. During a week that the White House touted its "Buy American, Hire American" initiative, Bowen lost a military contract worth up to $1 million, to a supplier that would make many of the masks in Mexico, he said.

"Shame on the Department of Defense! One of these days the US military will need America's manufacturers to help win another war or fight another pandemic - and they will not exist," Bowen wrote on Aug. 17, 2017, to Maj. Gen. Jeffrey Clark, a senior official with the Pentagon's Defense Health Agency.

Clark, who retired last year, did not respond to a message seeking comment.

- - - 

For Bowen, the first signs of trouble came in mid-January. Online orders through his company's website, typically totaling maybe $2,000 a year and accounting for only a fraction of his business, suddenly skyrocketed to almost $700,000 in a few days.

On Jan. 20, Bowen also fielded a call from the Department of Homeland Security, urgently seeking masks for airport screeners. Bowen said he did not have masks in stock to fill the order, but the call led him to contact Bright to tell him about the surge in demand for masks. "Is this virus going to be problematic?" Bowen wrote.

Inside HHS, Bright quickly passed Bowen's on-the-ground observations to a group that included Wolf, the director of the agency's Division of Critical Infrastructure Protection.

"Can you please reach out to Mike Bowen below? He is a great partner and a really good source for helpful information," Bright wrote on Jan. 21.

"Thanks Rick," she replied. "We are tracking and have begun to coordinate with fda, niosh, and manufacturers today. More to follow tomorrow. Thinking about masks, gowns (inc those in shortage), gloves, and eye protection."

Within a day, Bowen sent an email to Wolf laying out what Prestige could do. The company's four mothballed manufacturing lines could be restarted with large noncancelable orders, he wrote.

"This is NOT something we would ever wish to do and have NO plans to do it on our own," he wrote. "I'm simply letting you know that in a dire situation, it could be done."

Over the next three days, Bowen kept HHS officials informed as orders for a million masks came in from intermediaries for buyers in China and Hong Kong. On Jan. 26, he sent the email warning that the U.S. mask supply was at "imminent risk."

Bright forwarded it that day to Kadlec and others, urging action: "We have been watching and receiving warnings on this for over a week," he wrote.

The next day, Bright wrote to his deputy asking him to explore whether BARDA could divert money earmarked for vaccines and other biodefense measures to instead buy masks.

From his end, Bowen said his proposal seemed to be going nowhere. "No one at HHS ever did get back to me in a substantive way," Bowen said.

The senior U.S. official said Bowen's idea was considered, but funding could not easily be obtained without diverting it from other projects.

Bowen started talking to reporters about the mask shortage in general terms. He was soon invited to appear on former Trump adviser Stephen K. Bannon's podcast: "War Room: Pandemic."

On the Feb. 12 podcast, the two commiserated over the beleaguered state of U.S. manufacturing. "What I've been saying since 2007 is, 'Guys, I'm warning you, here's what is going to happen, let's prepare,' " Bowen said on the program. "Because if you call me after it starts, I can't help everybody."

Bowen said Bannon put him in touch with Navarro, the White House economic adviser.

Navarro was quick to see the problem, Bowen said. After talking with Navarro, Bowen wrote to Bright that he should soon expect a call from the White House, "I'm pretty sure that my mask supply message will be heard by President Trump this week," Bowen wrote. "Trump insider reading yesterday's Wired.com article, the ball is screaming toward your court."

According to Bright's complaint, he soon began attending White House meetings and helping Navarro write memos describing the supply of masks as a top issue. Emails and memos attached to the complaint show Bright reporting back to Kadlec and others about his work with Navarro.

None of it turned the tide for Bowen. 

Nearly a month after his emailed offer, Bowen received his first formal communication about possibly helping to bolster the U.S. supply. The five-page form letter from the Food and Drug Administration - one Bowen said he suspected was sent to many manufacturers - asked how his company could help with what was by then a "national emergency response" to the shortage of protective gear.

Bowen responded on Feb. 16, by firing off a terse email to FDA and HHS officials. He directed the agencies to a U.S. government website listing approved foreign manufacturers of medical masks. "There you'll find a long list of . . . approved Chinese respirator companies," he wrote. "Please send your long list of questions to them."

In March, Bowen submitted a bid to supply masks to the Federal Emergency Management Agency, which by then had taken over purchasing.

The government soon spent over $600 million on contracts involving masks. Big companies like Honeywell and 3M were each awarded contracts totaling for over $170 million for protective gear. One distributor of tactical gear - a company with no history of procuring medical equipment - was awarded a $55 million deal to provide masks for as much as $5.50 a piece, eight times what the government was paying months earlier.

On April 7, FEMA awarded Prestige a $9.5 million contract to provide a million N95 masks a month for one year, an order the company could fulfill without activating its dormant manufacturing lines. For the masks, Prestige charged the government 79 cents a piece.

 

 

 

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