FDA dithers over BMI (Battelle Memorial Institute) mask technology approval
[PJ] Ohio Attorney General Dave Yost has had enough of the FDA's dithering over approval of an innovative process that could get millions of N95 masks to hospitals and other healthcare facilities, where they are in critically short supply as the Chinese coronavirus continues to stretch their resources. "If this isn't cleared up by morning, I'm ready to sue the FDA," Yost wrote on his Facebook page on Sunday afternoon.
What's the problem? Yost says the FDA is limiting the number of masks that an Ohio Company, Battelle Memorial Institute, can sterilize for reuse. The company has pioneered a technology that uses hydrogen peroxide vapor to make N95 masks safe for reuse and wants to ramp up production at their facility so they can send the masks where needed, but the FDA essentially shrugged and seemed to say, 'what's the big hurry?'
"The Food and Drug Administration -- after dithering all week -- finally gave Battelle approval to sterilize a measly 10,000 masks a day," Yost said. "They could be doing 160,000 per day."
And while the FDA dithers, grandmas across the nation are hunched over their sewing machines, heroically pumping out handmade masks to help fill the need for the critical protective masks.
"Gov. Mike DeWine has called the President. The FDA commissioner assured him that this would be taken care of. But as of this writing, the FDA has not moved," said Yost.
President Trump praised Battelle on Twitter Saturday, and urged the FDA to move quickly to approve increased production of the masks:
Posted by: Besoeker 2020-03-30