The Hill
BY REPS. PAUL TONKO (D-N.Y.), DON BACON (R-NEB.), AND SENS. DEB FISCHER (R-NEB.), AND KYRSTEN SINEMA (D-ARIZ.), OPINION CONTRIBUTORS
The coronavirus has come to America, but public health workers here lack an adequate supply of the respiratory protective devices (respirators) designed to protect them against airborne diseases. The disease has spread globally with the number of infected people and death tolls rising daily. The Centers for Disease Control and Prevention (CDC) activated its Emergency Response System on Jan. 21.
Unfortunately, the U.S. Strategic National Stockpile, which includes respirators the CDC has recommended for worker safety during public health emergencies, has not been replenished since the 2009 H1N1 virus outbreak.
We’re referring to professional-grade N95, powered air purifying respirators and others certified by the National Institute for Occupational Safety and Health (NIOSH) that health care workers need while treating suspected or infected victims. No one can imagine public-health workers doing their life-saving work without the benefit of proper personal protective equipment.
As we move to replenish the national stockpile of those respirators, Congress first needs to fix a past legislative oversight which omitted NIOSH-certified respirators from the liability protections afforded to drugs, biological products, and other FDA-approved devices. Under the Public Readiness and Emergency Preparedness Act (PREP) Act, the federal government assumes the liability, if there is any, for items identified as necessary for public health emergency response. In fact, a federal fund is set aside to pay out any claims from someone who used a PREP Act-covered item.
We introduced bipartisan bills in both the House and Senate to fix that problem. With coronavirus now in the U.S., it’s time to quickly pass this legislation.
In a PREP Act declaration, the U.S. government determines what products are to be used to protect health care workers. This ensures that the government and health care workers can get quick deliveries of drugs and other items covered under the PREP Act so they can respond to the emergency.
If coronavirus infections continue to increase rapidly, the Department of Health and Human Services will undoubtedly issue a PREP Act declaration for appropriate equipment for health care workers and first responders. Given that the CDC is recommending N95 masks and reusable respirators, such as powered air purifying respirators to keep people safe from coronavirus exposures, these NIOSH-certified respirators should be among the products in the declaration. But Congress must first pass legislation to include them on the list of covered products.
Neglecting to include respirators on the list of covered products puts the people supplying, distributing, and manufacturing this lifesaving equipment in a tough spot.
Right now, businesses that provide and distribute respirators must embrace the very real possibility of opportunistic lawsuits. These companies have no federal protection like that provided to companies selling vaccines and other products needed in a public health emergency. Such lawsuits could cause insurers of manufacturers or suppliers to stop covering public health use of respirators or drop coverage completely. Suppliers of these respirators should not be left exposed to a potentially catastrophic liability risk.
The fix is simple: parity. Treat respirator providers just like every other medical device or drug company protected under the PREP Act.
Our bill will provide long-overdue protection for manufacturers and suppliers of NIOSH-approved respirators during federally declared health emergencies.
The clock is ticking. We in Congress need to move faster than this latest virus and pass this legislation to keep Americans safe.
Paul Tonko represents New York’s 20th District. Don Bacon represents Nebraska’s 2nd District. Deb Fischer represents the state of Nebraska. Kyrsten Sinema represents the state of Arizona.