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Face masks in the national stockpile have not been substantially replenished since 2009

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The H1N1 influenza pandemic of 2009 triggered the largest deployment in U.S. history of the Strategic National Stockpile, the federal government's last-resort cache of drugs and medical supplies. The stockpile distributed 85 million N95 respirators - fitted face masks that block most airborne particles - along with millions of other masks, gowns and gloves.

The gear to protect medical personnel came from multibillion dollar emergency funding authorized by Congress in 2007 and 2009, leading to calls for the government to better prepare for the next outbreak.

The trade group for manufacturers of personal protective equipment in mid-2009 urged "immediate action" to restock N95 masks. The International Safety Equipment Association warned of "significant shortages" if another pandemic caused demand for masks to surge.

A nonprofit representing public health agencies, the Association of State and Territorial Health Officials (ASTHO), echoed industry's appeal in a 2010 report funded by the federal government, recommending the repository of masks be "replenished for future events."

But the stockpile's reserves were not significantly restored after the 2009 pandemic, in the view of industry and public health experts. With a limited budget of about $600 million annually, officials in charge of the stockpile focused on what they say was a more pressing priority: lifesaving drugs and equipment for diseases and disasters that emerged before the new coronavirus, which has no vaccine or specific anti-viral treatment.

"In hindsight, it appears to be shortsighted," said Gerrit Bakker, ASTHO senior director of public health preparedness. "It's an issue of, 'Will there be any (masks) left when they get to me? And if the stockpile won't have enough for my state, what am I going to do?' "

The limitations of the stockpile - valued at $7 billion - reflect challenges in what many experts say is an underfunded public health system that leans toward smaller inventories to hold down costs and looks to fast-moving private supply chain when crises emerge. Public health and emergency preparedness officials also say the stockpile's budget lags behind the expanding threats of the past two decades - from terrorist attacks, to natural disasters to deadly infectious diseases.

The Department of Health and Human Services said last week that the stockpile has about 12 million N95 respirators and 30 million surgical masks - 1% of the estimated 3.5 billion masks the nation would need in a severe pandemic. Another 5 million N95 masks in the stockpile are expired.

Robert Kadlec, HHS assistant secretary for preparedness and response, mistakenly told a Senate committee last week that the stockpile held 35 million N95s. "It strikes me we should have substantially more," said Sen. Mitt Romney, R-Utah, before health officials corrected Kadlec's error, saying there only one-third that many.

HHS announced last week that it planned to buy 500 million N95 masks over the next 18 months. To spur private industry, the government is guaranteeing that it will buy them even if coronavirus dissipates and hospitals cancel orders.

Bids are being accepted through March 18, but masks are already in high demand. On Tuesday, the Centers for Diseases Control and Prevention loosened its guidelines to match generally those of the World Health Organization, which recommends respirators only for procedures that cause the patient to cough, sending tiny virus particles into the air. "Facemasks are an acceptable alternative when the supply chain of respirators cannot meet the demand," the CDC said in a statement that is expected to unsettle health-care workers who have been trained to use the more protective gear during contagions.

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Washington state initially received half of the 233,000 respirators and 200,000 surgical masks that authorities urgently requested from the stockpile. After an outcry from lawmakers, federal officials said the state would receive more masks.

In California, expired N95 masks are being distributed from a state stockpile to ease hospital shortages. The CDC has approved the use of several models of N95 masks beyond their expiration date "due to the potential urgent demand."

Massachusetts General Hospital in Boston, one of the top research hospitals in the nation, had less than a week's worth of N95s left before a shipment arrived late Friday.

The CDC recommendations on maximizing the use of N95s include a section on "when no respirators are left." As part of the White House effort to tamp down worries about coronavirus, Vice President Mike Pence recently visited Minnesota-based 3M and touted its production of 35 million a month.

Before coronavirus hit, HHS estimated $620 million in stockpile spending for the current fiscal year, compared with $610 million in each of the previous two years. The department also estimated that maintaining and replenishing the current inventory would cost $1.1 billion in the 2021 fiscal year.

How to allocate the stockpile's limited budget is a matter of debate.

Charles Johnson, president of the ISEA trade group, said the organization "is unaware of a significant restocking" of personal protective equipment since 2009. "We have always advocated replenishing the supply whenever it's tapped," he said.

Greg Burel, who served as director of the stockpile for more than 12 years until he retired this year, generally agreed with the trade group's assessment of personal protective equipment reserves.

Much of the protective equipment for the 2009 flu pandemic was purchased with billions of dollars in additional funding approved by Congress. That funding did not become permanent.

"Goals are balanced against available resources for procurement over time," said an HHS spokeswoman who declined to speak on the record. "The SNS' role is to supplement state and local supplies during public health emergencies."

Burel said he has no regrets about the stockpile's spending. If the stockpile had not invested in certain lifesaving pharmaceuticals, he said, manufacturers would have stopped making them.

"If there is a drug product that we must have or else people would die and a commercial product we can buy in a time of need, then we're going to invest in that drug product," Burel said. "Those are the kind of hard decisions you have to make."

In 2013, scientific advisory boards to the federal government highlighted the stockpile's insufficient funding. "If the current trajectory is left unchanged, we anticipate a widening gap between the explicit and implicit responsibilities of the SNS and the resources available to fulfill those responsibilities," the advisory boards wrote in recommendations for improvements by 2020.

That sentiment was echoed in a 2016 report by a National Academy of Sciences, Engineering and Medicine committee, in which one participant said: "The resources that American people are willing to commit to a Strategic National Stockpile are not sufficient to meet all of the expectations."

A detailed breakdown of the stockpile's annual spending is not publicly available because of national security concerns; officials say they do not want to give terrorists a road map flagging the nation's strengths and vulnerabilities. Even the locations of the warehouses are kept secret. A Washington Post reporter who visited one in 2018 on the condition that the location not be disclosed saw hundreds of thousands of shrink-wrapped boxes of medicines, stacked nearly five stories high.

"If you imagine the largest big-box store you've ever been in and multiply that by 10, that's what it looks like," said Tom Frieden, the former head of the CDC. "It's a really impressive national resource."

Budget documents offer a glimpse of the stockpile's priorities. In the fiscal year that ends in September, the HHS planned to spend $9 million on antivirals for pandemic influenza, $38 million for an anthrax antibiotic, $97 million on a nerve agent antidote and about $200 million on smallpox vaccines and antivirals. The stockpile holds more than enough smallpox vaccines for the entire U.S. population, according to a 2017 federal strategic planning document.

President Donald Trump has signed off on $8.3 billion in emergency funding to fight coronavirus, of which $3.1 billion would flow to health officials to purchase additional stockpile supplies, finance research into vaccines, treatments and diagnostic tests and support emergency preparedness programs.

The stockpile program was created in 1999 under President Bill Clinton amid fears triggered by the first World Trade Center bombing in 1993 and the sarin gas attack on the Tokyo subway and the Oklahoma City, Oklahoma, bombing in 1995. Originally called the National Pharmaceutical Stockpile, it was designed to be able to deliver medicine and other supplies within 12 hours in response to chemical, biological, radiological and nuclear threats. The Sept. 11, 2001, attacks and subsequent anthrax threats fit the bill.

But a series of devastating hurricanes and floods put other demands on the federal stockpile for refrigerators, bottled water and vaccines for tetanus, rabies and hepatitis. More recently, the Ebola epidemic and Zika outbreak posed different challenges. Combating Zika required mosquito spray, said Tara O'Toole, undersecretary for science and technology under President Barack Obama and chair of the National Academy of Sciences, Engineering and Medicine committee in 2016 that examined challenges facing the program.

"The stockpile is suffering from mission creep. Actually it's mission gallop," she said. "What do we put in the stockpile? Everything?"

In late 2018, responsibility for managing the stockpile shifted from the CDC to a different part of the HHS. That arm, headed by Kadlec, assistant secretary for preparedness and response (ASPR), already supervised the National Disaster Medical System, which deploys thousands of federal employees to help with major emergencies. That system has its own inventories of medical supplies and other equipment.

"Once we get into the situation where we have broad enough community spread and need to deploy the stockpile broadly, this will be a big test as to how well the shift to ASPR has worked," said Georges Benjamin, executive director of the American Public Health Association.

Delaware as of Tuesday afternoon had no confirmed cases of the disease caused by coronavirus but has already put in a request for a 120-day supply of N95 masks, said Steven Blessing, one of state's top public health officials. About 75% of the state's supply is usable, he said.

"We're managing it very carefully and making sure the people using the masks really need them to treat folks in the most dangerous situations," Blessing said. "I feel pretty confident about where we are right now. We have a lot of confidence in the stockpile and think they're a great partner."

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The Washington Post's Julie Tate and Dalton Bennett contributed to this story.

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