Federal Regulations are Preventing Antibody Tests From Being Rolled Out

Economic and public health experts have said that the biggest thing standing between the U.S. and the re-opening of the economy is widespread testing. Until we know exactly what kind of situation we have on our hands, there’s just no way to safely get people back to work in massive numbers. Therefore, it is imperative that we ramp up testing way beyond our current capacities, and that includes antibody testing, which will give us much more information about who has already contracted the virus and how many people are walking around with asymptomatic cases of the disease.

So, since everyone from the Oval Office on down knows that this should be the country’s #1 priority, what’s the hold-up?

Well, according to Dr. Stephen McColgan of Vivera Pharmaceuticals, the problem is that the FDA is preventing these tests from rolling out due to a bunch of federal regulations. In an interview with Fox News’s Tucker Carlson on Wednesday night, McColgan said that his company has been sitting on a “rapid antibody test” for three weeks, but FDA red tape has kept this essential tool from reaching the American people.

“We have a rapid antibody test, and the key to this is, this is part of the solution to the crisis,” McColgan said. “It identifies patients who have immunity and it identifies people that can give plasma for critically ill patients.”

McColgan said that Vivera had acquired the test from Germany, the country that has experienced some of the lowest mortality rates from the coronavirus. Part of that, he said, is because Germany has done a much better job of testing the entire population to see who is and isn’t already immune to the disease. This allows for a much more targeted social distancing campaign – one that works without shredding the entire economy into a million tiny pieces.

“They are sending all sorts of stuff over here and that’s why this is high quality, high value,” he said. “I know President Trump is a problem solver and he’s decisive and a made-in-America kind of guy so our goal is to make get America back to work again and to make America well again.”

He explained that the test isn’t just about getting immune people back to work, either.

“So when you have a patient that’s had the infection and recovered, they have antibodies,” he said. “Those antibodies mean they have had immunity. So when you spin the plasma off their blood and give it to the critically ill patient, those antibodies fight the viral infection and allow that patient to recover and his immunity to pick up. So it’s critical at this point.”

So why, Tucker asked, is America sitting idly by while letting Germany and other European countries take advantage of this critical test?

“Yeah, I don’t know,” said McColgan. “You know the red tape and the FDA and President Trump has been trying to cut through it and, you know, they take their time. I don’t know why. New York’s been crying about no testing, no tests, we’ve had these tests for three weeks. We’re just trying to deploy it. It’s the way the red tape of government moves slowly.”

Absolutely unacceptable.


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