President Trump on 27 March signed into law a $2.2tn COVID-19 stimulus package that provides $80m to the Food and Drug Administration for emergency use authorizations of medical products, and doles out billions to other agencies to help fight the spreading virus.
The US House approved the package earlier in the day, after the Senate passed the Coronavirus Aid, Relief and Economic Security (CARES) Act on 25 March.
The $80m set aside for the FDA in the bill is expected to be used “to prevent, prepare for and respond to the coronavirus, including funds for the development of necessary medical countermeasures and vaccines, advanced manufacturing for medical products, the monitoring of medical product supply chains, and related administrative activities,” said Steven Grossman, deputy executive director of the Alliance for a Stronger FDA. The group, which lobbies for more funding for FDA, had endorsed the bill.
“FDA will continue to take actions to help increase the supply of ventilators … as well as filtering facepiece respirators due to COVID-19 shortages, as part of our commitment to ease burdens on the health care system during the pandemic.” – Stephen Hahn
An example of actions the FDA will use the CARES Act dollars for, in order to address medical supply shortages, could be seen in its 22 March“ immediately in effect” guidanceto allow medtech manufacturers to modify medical-use ventilation equipment, including anesthesia gas machines and continuous positive airway pressure (CPAP) devices, to increase the US supply of ventilators. (Also see "FDA Allowing Modifications To Ventilator Equipment To Bolster Supplies During COVID-19 Crisis" - Medtech Insight, 23 Mar, 2020.)
The agency also on 26 March relaxed some regulatory requirements on facial masks, and is expected to allot some of its $80m cut of the stimulus package funding to reviewing new emergency use authorization (EUA) applications from manufacturers that develop ways to safely reprocess N95 respirators worn by medical staff treating COVID-19 cases, the FDA said in a guidance. (Also see "COVID-19 Leads FDA To Relax Rules On Surgical Masks, Offer EUAs For Reprocessing Some Respirators" - Medtech Insight, 26 Mar, 2020.)
“FDA will continue to take actions to help increase the supply of ventilators … as well as filtering facepiece respirators due to COVID-19 shortages, as part of our commitment to ease burdens on the health care system during the pandemic,” FDA commissioner Stephen Hahn said in a 27 March statement.
CDC Will Use Funding To Distribute Lab Tests, PPE
In addition to supporting the FDA’s work issuing EUAs for point-of-care tests and new medical equipment, the bill gives a total of $4.3bn to the Centers for Disease Control and Prevention (CDC) to distribute to states, cities and counties to purchase laboratory test kits, ensure infection control, and to purchase personal protective equipment (PPE), including N95 masks, gowns and gloves, according to a Senate Appropriations Committee summary of the CARES Act.
A $1.5bn chunk of the CDC’s dollars will go to the state governments for laboratory testing to detect positive COVID-19 cases, for contact tracing to identify additional cases, to buy PPE, and for surveillance for coronavirus, the summary said. Another $1.5bn is allocated to repatriation and quarantine efforts, support for use of lab-developed tests by cities and counties, and to combating antimicrobial resistance from secondary infections related to COVID-19.
The CDC will also spend $500m for global disease detection and emergency response, and $500m for public health surveillance and analytics infrastructure modernization. Meanwhile, $300m of that agency’s dollars will replenish the Infectious Diseases Rapid Response Reserve Fund, which supports immediate response activities during outbreaks.
FEMA Dollars Will Help Distribute Needed Countermeasures
Under the umbrella of the Department of Homeland Security, which will receive $45.8bn of the CARES Act funding to help people, communities and frontline personnel prepare for and recover from coronavirus, the Federal Emergency Management Agency (FEMA) will use $45m to build capacity at hospitals and treatment centers, and coordinate distributions of medical equipment from the Strategic National Stockpile.
For example, the FEMA has been instrumental since early March in purchasing additional ventilators and other medical equipment for use by states and communities where it’s most critically needed, and the medtech industry – represented by AdvaMed – recently formally asked the agency for assistance in distributing additional ventilators manufactured in response to the coronavirus crisis to COVID-19 hotspots. (Also see "COVID-19: AdvaMed Asks FEMA To Centralize Procurement, Allocation Of Ventilators" - Medtech Insight, 25 Mar, 2020.)
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