New Bipartisan Bill Aims to Take On Counterfeit Medical Supplies — and Support Made in USA

By Elizabeth Brotherton-Bunch
Dec 14 2021 |
An N95 mask made by 3M. Getty Images

Sens. Tammy Baldwin (D-Wis.) and Bill Cassidy (R-La.) say their bill will address counterfeit medical devices and promote local manufacturing of critical goods like PPE.

We’re nearly two years into the COVID-19 pandemic, and sadly too many hospitals and health care systems remain overwhelmed by patients. And while progress has been made in addressing the virus — hello, vaccines! — there’s concern that the United States is still unprepared should another pandemic strike, especially if it proves more lethal.

New legislation introduced on Tuesday by Sens. Tammy Baldwin (D-Wis.) and Bill Cassidy (R-La.) aims to take on one of the lingering problems that rose to the forefront during the pandemic: counterfeit medical devices.

The Medical Device Integrity Act would give the Food and Drug Administration (FDA) authority to require that medical device manufacturers respond to records requests to help the agency verify the quality of these devices, which range from everything from bandages to ventilators to personal protective equipment like PPE.

Counterfeit PPE is rampant. Flawed KN95 masks, many of them cheap imports from China, have flooded the market, undercutting American producers while also selling consumers a product that doesn’t provide adequate protection. It’s especially concerning because millions of fake masks have made it into hospitals and other medical facilities, putting healthcare workers on the front lines at risk.

The legislation introduced Tuesday sets out to give the FDA another tool in taking on the counterfeiters.

Right now, the FDA can request records from companies to help verify the legitimacy of their product, which is especially important because many FDA inspections were halted due to the pandemic. But companies aren’t required to respond. From February to May 2021, 40% of medical device manufacturing facilities didn’t submit records when requested, according to Baldwin’s office.

“The bipartisan Medical Device Integrity Act will ensure that the medical equipment – like masks, gloves, PPE, and more – we rely on are of the highest quality,” Baldwin said. “By rooting out poor quality medical equipment that is often made abroad, this legislation will also support our Made in America economy, supporting jobs across Wisconsin and the country.”

Supporting domestic production of PPE and other medical equipment is critical to taking on the current pandemic and preparing for the next one. The United States was woefully unprepared at the start of the COVID-19 pandemic, unable to make the things Americans desperately needed to respond to the virus.

But if we find ourselves in the same place during the next pandemic, we’ll only have ourselves to blame.

American manufacturers large and small stepped up to the plate in the wake of COVID-19, building and investing in facilities to make critical medical equipment like N95s. But since then, many have reported that they had to layoff workers or halt production because they cannot compete against cheap Chinese imports — which is especially grating considering so much of their competition is flawed or downright fake.

And as Cassidy pointed out, it isn’t just quality the United States needs to be worried about. In a statement, he reminded folks that when the pandemic broke, “China embargoed PPE manufactured by U.S. companies that was supposed to be sent to the U.S. This endangered Americans.” 

That’s why identifying and addressing counterfeits right now is critical. The United States needs to ramp up and maintain domestic production of PPE. But counterfeit PPE, priced far below fair market value, undercuts American producers and puts consumers in danger. It shouldn’t be on the market at all — and agencies like the FDA need to be able to use all available tools at their disposal to root out the fakes.