Gov Battles FDA Over Ohio Tech

Governor Mike DeWine came out swinging in his fight to get the Food and Drug Administration to approve new technology to sterilize surgical masks.  He called an unscheduled press conference on Sunday to call out the agency on its inaction. Here are the 6 crucial takeaways.

Ohio has 29 COVID-19 deaths

Ohio has a critical shortage of Personal protective gear like surgical masks for the fight against Coronavirus. Currently Ohio has 1,653 confirmed cases of the virus in 66 counties. There have been 29 deaths.

New Tech Will Save Lives

Ohio-based company Battelle Labs say they have created new machines capable to sterilizing up to 80,000 N-95 masks each per day. They have two ready to go in Ohio, three ready to ship to COVID-19 hot spots, and expect to have 15 more ready to go sometime next week.

Governor Frustrated With FDA

The Governor says the FDA told him approval was on the way, but that turned out to be the case. He thought that approval had been granted around 1 am on Sunday, but woke up to find that the approval was limited to sterilizing just 10,000 masks per day and only in Ohio. “When you’re dealing with people who say approval is coming you tend to believe them. When you find out that’s not the case. “It’s time to move.”

Lt. Governor Jon Husted said, “I’ve never seen the governor more frustrated. This needs to be approved today. We can’t tiptoe towards this situation. We have to run full-speed.”

It’s estimated that Ohio will need 11.7 million of the N-95 surgical masks when COVID-19 cashes surge. This new technology could sterilize 160,000 masks per day.

Battelle Labs CEO Lewis Von Thaer says, “We believe we can make this not be an issue for the state of Ohio.”

DeWine: FDA Must Help First Responders

DeWine blasted the FDA for not doing all it can to protect hospital personnel, first responders, nursing home workers, and other healthcare professionals. “”All of these people who are at the front line. Who charge towards danger when we pull back. They need our help.”

Gov Went Straight To The Top

The Governor said he’d gone straight to the top to fix the issue. “Needless to say I was quite angry. I picked up the phone and called President Trump. He called me back. He said he would do everything he could to make sure this got done today. ”

He said the FDA had been in touch with his administration and Battelle labs. DeWine had high hopes the issue could be worked out sometime today. He said the new tech “…has the ability to help here in Ohio and across the country.” DeWine said he wanted to , “Not only to appeal to the FDA but to express to other governors and other states that help is on the way.”

 

FDA Must Speed Up

The Governor says he realizes that bureaucracy is sometimes slow-moving. “That’s not just true in Washington but also in Columbus. I’ve received calls, sometimes not as urgent, and had to get into the bureaucracy and get it done.”

Lt. Governor Husted said that while the FDA is mainly concerned with safety, he’s more interested with the situation on the ground.

DeWine agreed. “There’s a lot of moving parts. The FDA does what it does. They want to make sure things are safe, I get that. Sometimes you gotta rattle it. We have to protect the people on the front line. We don’t have enough of these masks and we have a solution. Free Us. Let Us do it.”

 

 

 

 

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