Steely resolve, seamless coordination and smart decisionmaking will not be enough to end the COVID-19 pandemic in the United States. It's also going to require a lot of stuff — much more than we have today, according to the Biden administration.
N95 respirators. Rubber gloves. Rapid test kits and swabs. Special syringes to extract a sixth dose of vaccine from a vial intended to hold five. Enough medical supplies to inject Americans with 600 million doses of vaccine.
All this and more are subject to continued use of the Defense Production Act (DPA), according to President Joe Biden's 198-page national strategy for the pandemic. Supplies for testing, vaccination and personal protection top the list.
The Korean War-era law compels private companies to prioritize federal government contracts over other business, and creates financial incentives to expand domestic production. It includes exemptions from antitrust laws when voluntarily cooperating with the Federal Emergency Management Agency.
Labor union National Nurses United enthusiastically cheered the news, saying a comprehensive COVID response plan that fully uses the DPA could lead to increased manufacturing of supplies like N95 masks and other protective equipment. Manufacturers, under pressure to produce more supplies, acknowledge the law can help spur more capacity.
But medical technology trade group AdvaMed says the flow of medical supplies is often limited by allocation problems in the field.
"We now have a deep understanding of how [the DPA] can be an effective tool in some cases and disruptive in others," AdvaMed CEO Scott Whitaker said in a Jan. 22 letter to Biden.
The DPA has several tools that let the president shape the economy for national defense: Title I of the law forces companies to devote manufacturing capacity to its orders, Title III provides incentives to get companies to build what the government wants, and Title VII allows company executives to form voluntary groups to encourage production, even when such coordination might normally be illegal. The Trump administration used the DPA to prioritize contracts for billions of dollars' worth of masks, drugs, testing and diagnostic supplies, and personal protective equipment throughout 2020.
Maplewood-based 3M Co. got several different Title I and Title III contracts throughout last year to produce N95 masks, while Ireland-based Medtronic got a Title I contract to produce mechanical ventilators for critical care patients.
Yet the nonpartisan Government Accountability Office in November urged further use of the law "to increase domestic production of key medical supplies [which] can help alleviate national security risks from continued reliance on foreign manufacturers."
The stack of executive orders Biden was photographed signing at the Resolute Desk on Jan. 21 included one that orders a national inventory of pandemic supply shortfalls, with an eye to revising unrealistic delivery estimates and taking "immediate action" to secure necessary supplies:
"The head of the relevant agency shall … take appropriate action using all available legal authorities, including the Defense Production Act, to fill those shortfalls as soon as practicable by acquiring additional stockpiles, improving distribution systems, building market capacity, or expanding the industrial base."
Kathryn Jordan Mims, a Washington, D.C.-based partner with business law firm White & Case, said virtually any company or subcontractor in the vaccine supply chain could be subject to the DPA in 2021.
"A company is likely not to have much of a choice when it comes to accepting a priority-rated contract," said Mims, speaking about the DPA in general. "Maybe it's a PR opportunity. This is an opportunity to showcase patriotism, or their willingness to work with the government."
3M, which developed the N95 mask in the 1990s, entered 2021 on a high note financially, announcing last week that it projects 8% sales growth for the year.
The company used DPA funds and orders last year to help quadruple its monthly output of N95 masks to 95 million per month, made at plants in South Dakota and Nebraska.
"We welcome President Biden's leadership," 3M spokeswoman Jennifer Ehrlich said via e-mail last week, when asked about the DPA. "We have been actively engaged with Biden's team since the transition period."
Rhode Island-based Honeywell Safety Products USA, which got DPA contracts to produce N95 masks last year, declined to comment on any discussions with the Biden administration.
"As a longstanding national security partner and government contractor, Honeywell is very familiar with meeting the demands of the Defense Production Act and is committed to supporting the COVID-19 response efforts," spokesman Eric Krantz said in an e-mail last week.
The start of the pandemic a year ago triggered an international scramble for medical supplies and kits needed to run COVID tests.
Even now, front-line caregivers are wearing N95 masks over multiple days and decontaminating them with each use, even though the face-worn air filters were designed as single-use items and their rubber straps can degrade over time.
But with two vaccines already approved in the U.S., and more vaccine candidates on the way, the Biden administration has specifically cited the need for mass vaccination as reason to invoke the DPA.
Andy Slavitt of Edina, a former Medicare administrator who is advising the White House on pandemic response, told reporters last week that the DPA is "a very important vehicle for us" and that even large projects are being considered.
"Whether a factory can be retrofitted to mass produce another vaccine — that is under active exploration," Slavitt said. "As you can imagine, it is not as simple as walking in and flipping a switch."
Nationwide needs
The pandemic supplies with identified shortfalls are:
• N95 masks
• Isolation gowns
• Nitrile gloves
• Polymerase chain reaction (PCR) sample c ollection swabs
• Test reagents
• Pipette tips
• Laboratory analysis machines for PCR tests
• High-absorbency foam swabs
• Nitrocellulose material for rapid antigen tests
• Rapid test kits
• Low dead-space needles and syringes
• "All the necessary equipment and material to accelerate the manufacture, delivery, and administration of COVID-19 vaccine."
Joe Carlson • 612-673-4779
