Biden’s COVID-19 response will make manufacturers busy

Manufacturers of vaccine supplies and personal protective equipment can expect more work as the new Biden administration rolls out its “full-scale, wartime” plans to combat the COVID-19 pandemic.

In one of his first official acts as president, Joe Biden announced a plan to “fully use” the Defense Production Act to ramp up manufacturing of testing supplies, masks, face shields and other PPE, with an eye toward boosting American manufacturing to reduce reliance on other countries. The president also announced his intention to invest $25 billion in a vaccine manufacturing and distribution plan that will provide vaccines to all Americans, free of charge. The vaccine distribution is part of Biden’s $1.9 trillion economic stimulus plan that he wants Congress to pass.

A statement from the White House announced plans to establish a Pandemic Testing Board, similar to President Franklin Roosevelt’s War Production Board from World War II, to produce and distribute tens of millions of tests for COVID-19.

On Tuesday, Biden signed an executive order requiring everyone on federal property to wear a mask. Today, he asked every governor to make mask-wearing mandatory in their state, and local authorities to also make it mandatory to buttress their state orders.

The new Biden administration also plans to ask Congress to pass an emergency package to ensure schools have the additional resources they need to adapt effectively to the virus. And it proposed a “restart package” to help small businesses cover the costs of PPE and plexiglass so they can operate safely.

An impressive challenge for medtech manufacturers

Biden’s plans reflected what some in industry and public health have been asking for for months — more production and better distribution. Representatives of the International Safety Equipment Association (ISEA), which includes the major manufacturers of N95 masks, told reporters in December that they plan to ask the federal government to establish a new emergency PPE distribution system in coordination with the states.

Companies like Becton Dickinson (NYSE:BDX) are already facing an arguably impressive challenge. The Franklin Lakes, N.J.–based medtech giant already has commitments to provide more than 1 billion needles and syringes to deliver future COVID-19 vaccines in the U.S., UK, Canada and elsewhere. Over the summer, HHS’s Biomedical Advanced Research and Development Authority (BARDA) covered more than half of the $70 million in costs for BD to expand syringe and needle production in Nebraska. The company recently announced $1.2 billion to expand and upgrade multiple drug-delivery facilities to support the expected transition to pre-fillable syringes for COVID-19 vaccines.

The Nebraska plant expansion is “well underway” and “on target to bring that capacity online this summer, which will add hundreds of millions of additional domestically produced needles and syringes annually,” BD spokesman Troy Kirkpatrick told Medical Design & Outsourcing in an email.

BD officials have already met with the Biden transition team and COVID-19 Advisory Board “to ensure they understand all that BD can bring to the table to help support the U.S. response to COVID-19,” Kirkpatrick added. “We have not received any new orders for injection devices beyond our existing contracts for 286 million needles and syringes that we have previously disclosed and were ordered during the Trump administration.  The U.S. government will have priority access to those manufacturing lines as part of the public/private partnership. We look forward to continuing discussions with the Biden administration and stand ready to support a heightened COVID-19 response in the United States while also ensuring our continued support of routine health care.”

Medline announced in November that it would repurpose part of a Georgia factory to produce medical face masks, beginning this month. The Northfield, Ill.-based company said it is modifying its Lithia Springs, Ga., plant to begin its first North American face mask production, and anticipates launching a second production line launching later in 2021. When the two lines are fully operational, Medline estimates it will produce 36 million face masks per month.

3M is manufacturing more N95 masks than it ever has, Denise Rutherford, senior VP of corporate affairs for the company, said in December. So has family-owned Moldex, which established a new factory outside Nashville, Tenn., to manufacture N95s. Moldex also added N95 production at its Culver City, Calif. headquarters, said company sales VP Bill Schubach, but he could not provide production figures.

Officials at 3M have also been meeting with Biden’s team since the transition began “and remain committed to doing all we can to help America fight COVID-19,” the company said in a statement to MDO. “It’s been a year since 3M began our early and rapid ramp-up of N95 production at all our plants. We’re making more than 95 million respirators at month at our plants in South Dakota and Nebraska — quadrupling production over the last 12 months. We are also focusing on distribution and how best policymakers can use existing tools or employ new authorities to ensure that we are balancing stockpiling with meeting current demand.”

3M also said it has ramped up the production of reusable respirators and powered air-purifying respirators (PAPRs), and accelerated production of other products used in the response to COVID-19, including biopharma filtration products used in developing drugs and vaccines, hand sanitizers and disinfectants used in hospitals.

Congratulations from the medical device industry

The medical device industry responded with congratulations to Biden and Vice President Kamala Harris on their inaugurations and pledged their support.

“We look forward to a new era of bipartisanship on behalf of the patients our industry serves,” AdvaMed president & CEO Scott Whitaker said in a statement. “At AdvaMed, our top priority is delivering next-generation innovation to save and improve lives, and we are encouraged to by your readiness to improve patient access and patient outcomes. We stand ready to work with you and your teams to ensure that all Americans can continue to receive the very best health care in the world.”

“MDMA congratulates President Biden and Vice President Harris on their inauguration, and we wish them the best as they work to help unite our nation, and to confront the ongoing challenges presented by the COVID-19 pandemic,” said Medical Device Manufacturers Association’s president & CEO Mark Leahey in a separate statement. “Medical technology innovators have a long, proud tradition of solving some of the most pressing challenges that patients and physicians face. MDMA remains committed to working with policymakers and stakeholders to help ensure that the United States remains the global leader in medical technology innovation, and that our industry continues to lead the way in developing lifesaving and life-changing cures and therapies.”

The Association of Public Health Laboratories also welcomed actions taken today by the new administration to scale up the federal response to the coronavirus pandemic.  “These steps will substantially boost testing and laboratory capacity, address chronic supply chain issues and improve reporting and collection of data to help further guide the public health response,” said Scott Becker, CEO of the trade group, in a statement. “Case counts and deaths due to the SARS-CoV-2 virus have eclipsed levels unimaginable just months ago. We have been at this for almost a year and clearly something needs to change. This reboot of our national response in a true partnership with states and localities will address many of our current challenges and help us better contain the virus.”

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